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Generic drugs

Doctors will only prescribe generic drugs from April

General pediatricians in Georgia will only be able to prescribe generic drugs to their patients, without specifying a drug brand, starting next month, Georgian Health Minister Zurab Azarashvili said on Sunday.

In an interview with the Imedi TV channel, Azarashvili said the decision was aimed at providing citizens with freedom of choice when it comes to medicines and was part of an effort to create a “well-regulated and transparent pharmaceutical market” in the world. country.

He also stressed the importance of not prescribing “biased or excessive amounts” of drugs, saying the ministry had drawn up an action plan to do so.

The news about generic drugs comes after the country imported drugs from Turkey-based producers, which led to a reduction in the prices of the drugs most in demand. A digital prescription system has also been operating since March 1, Azarashvili noting that it would facilitate “better regulation” of the market.

Georgian Prime Minister Irakli Garibashvili announced last week that general drug prices in the local Georgian market had been reduced by 60-80% following the import of drugs from Turkey, adding that products such as cardiovascular drugs had decreased from 220 GEL (around $68/€61) to 48 GEL (around $14/€13).

Garibashvili announced his team’s initiative to ensure a reduction in general pharmaceutical prices for citizens at the end of last year, citing the huge discrepancy between the cost of drugs produced under good manufacturing practices on the Turkish market and in Georgia.

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Generic drugs

Global generic drug market to reach $507.8 billion by 2026

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Editing: 7; Published: February 2022
Executive Pool: 1974
Companies: 42 – Players covered include Abbott Laboratories; Apotex Inc.; ASKA Pharmaceutical Co., Ltd. ; Aspen Pharmacare Holdings Limited; AstraZeneca Plc; Baxter International Inc.; Dr. Reddy’s Laboratories Limited; Eli Lilly and company; Endo International plc; Fresenius Kabi; GlaxoSmithKline Plc. ; H.Lundbeck A/S; Hospira; Lupine Pharmaceuticals, Inc.; Mylan NV; Novartis International SA; Novo Nordisk A/S; F. Hoffmann-La Roche AG; Sandoz International GmbH; Sanofi-Aventis US LLC; STADA Arzneimittel AG; Sun Pharma; Teva Pharmaceutical Industries Ltd. and others.
Blanket: All major geographies and key segments
segments: Type (small molecule generics, biosimilars); Therapeutic application (cardiovascular, central nervous system (CNS), dermatology, oncology, respiratory, other therapeutic applications)
Geographies: World; United States; Canada; Japan; China; Europe; France; Germany; Italy; UK; Spain; Russia; Rest of Europe; Asia Pacific; Australia; India; South Korea; Rest of Asia Pacific; Latin America; Argentina; Brazil; Mexico; Rest of Latin America; Middle East; Iran; Israel; Saudi Arabia; UNITED ARAB EMIRATES; Rest of Middle East; Africa.

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ABSTRACT-

Global generic drugs market to reach $507.8 billion by 2026
Generic drugs are described as the bioequivalent versions of brand name drugs in terms of safety, quality, stability, impact, strength, dosage form, and route of administration. Over the years, generic drugs have become safe and effective alternatives to brand name formulations. Generic variants differ from brand names in certain characteristics such as color, flavor and shape, although these factors have no impact on the safety and effectiveness of the drugs compared to the original version. Generic drugs are drugs that are made with the same active ingredient found in brand name drugs and also have the same therapeutic impact as their brand name counterparts. Medications are also prescribed in the same quantity as brand name medications. The method of consumption (route of administration) is also similar to brand name drugs. Generic drugs can only be marketed after the brand name drug patents have expired. The drugs are offered at much lower prices even though they are manufactured under the same strict manufacturing and safety procedures and maintain equivalent quality. A key advantage for generic drug manufacturers is that they do not need to invest time and money in drug R&D and marketing efforts, as generic drug prices are significantly lower compared to their branded counterparts.

Amid COVID-19 Crisis, Global Generic Drugs Market Estimated at US$402.9 billion in 2022, is expected to reach a revised size of US$507.8 billion by 2026, growing at a CAGR of 5.6% over the analysis period. Generic small molecules, one of the segments analyzed in the report, is expected to grow at a CAGR of 5.2% to reach US$325.7 billion at the end of the analysis period. After a thorough analysis of the business implications of the pandemic and the induced economic crisis, the growth of the biosimilars segment is readjusted to a revised CAGR of 6.3% for the next 7-year period. This segment currently accounts for a 37.7% share of the global generic drug market. With several factors encouraging growth contributing to wider adoption, biosimilars are poised to increase their share of the global generic drug market in the coming years. The rise of biosimilars has notably reduced overall drug spending in recent years, a trend that is expected to continue for the foreseeable future. The emergence of biosimilars in the market leads to increased competition, the next generation of biologics under development aims to improve safety, efficacy and cost factors compared to the drugs of the previous generation, which further adds to the competitive heat in the market.

The US market is estimated at $121.8 billion in 2022, when China is expected to reach $91.2 billion by 2026
The generic drug market in the United States is estimated at US$121.8 billion in 2022. The country currently accounts for a 30.46% share of the global market. Chinaworld’s second largest economy, is expected to reach an estimated market size of US$91.2 billion in 2026 with a CAGR of 7.2% over the analysis period. Other notable geographic markets include Japan and Canada, each predicting growth of 3.8% and 5% respectively over the analysis period. In Europe, Germany is expected to grow at around 4.3% CAGR while the rest of the European market (as defined in the study) will reach US$97.6 billion at the end of the analysis period.

The market is expected to be driven by the ever increasing risk of various chronic diseases such as hypertension, obesity and diabetes. Although pharmaceutical companies continue to develop branded drugs due to the shortage of new blockbuster drugs coming to market, generic drugs are expected to continue to meet the majority of these therapeutic needs of the population, especially the elderly population. in expansion. With the high cost of brand name drugs becoming a financial burden on people, efforts have intensified to develop cost-effective generic variants. Many branded drugs are unable to extend their exclusivity, resulting in the loss of patents and making way for affordable generics to be manufactured. The major application areas of generic drugs include cardiology, anti-infection, anti-arthritis, CNS, anti-cancer, and respiratory, among others. Generic drugs for cardiovascular diseases currently represent the dominant segment, accounting for the majority share of the overall market. Cardiovascular diseases such as heart failure, high blood pressure, circulatory disorders, dyslipidemia, cholesterol, arrhythmias, strokes and angina pectoris are the leading causes of death worldwide. The cardiovascular segment is expected to cover a larger portion of the global generic drugs market due to several patent expirations of these drugs. Generic drugs for infectious diseases would gain popularity over the next few years, mainly due to the increasing number of cases around the world. The COVID-19 pandemic has emerged as a significant growth driver for the generic drug market over the past year. As nations’ economies collapsed due to rising unemployment, the demand for cheaper substitutes for brand name drugs grew. Continued

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Medical products

This week’s big story: Stop banning medical product exports, report says

A new report from the National Academies of Sciences, Engineering and Medicine in the United States calls for an international treaty to prevent countries from banning exports of medical products, in a bid to prevent supply shortages.

The paper, called Strengthen the resilience of the country’s medical product supply chains, cites the restrictions that a number of countries have imposed on the export of medical products during the pandemic. Many of these still remain, as according to the World Trade Organization (WTO), 45 countries still had more than 70 restrictions in place in 2021, many of which applied to medical products.

The authors of the article go on to warn that export restrictions “can be dangerously counterproductive. What makes sense in an isolated emergency can be seriously detrimental in a global crisis.”

Globalization and the pharmaceutical industry

The pandemic has highlighted how dependent countries have become on imports to ensure they can meet domestic drug demand. China produces most of the active pharmaceutical ingredients (APIs) needed to manufacture common drugs such as penicillin and acetaminophen. India, in turn, relies heavily on imports from China to manufacture drugs for the US market, where it is the largest supplier of generic drugs.

The Russian invasion of Ukraine also raises fears that global supply chains could be disrupted. Russia signed an executive order this week banning exports of medical products from a list of countries it has deemed “unfriendly”, including the UK, EU, Canada, New Zealand, US States, Switzerland and Japan. This ban will apply to products stored in warehouses in Russia, or which pass through customs controls.

The need for collaboration

In the paper, the authors urge the US federal government to consider a multilateral agreement with major exporters of medical products that would be overseen by the World Trade Organization (WTO). They also suggest that the WTO could impose sanctions on countries that have not joined the agreement.

The 336-page document calls for greater international cooperation to prevent supply chain disruptions. It also contains detailed recommendations to prevent national shortages, such as pharmacy teams working with hospitals to inform them of a potential shortage and suggest alternative forms of treatment.

Earlier this year, the US Food and Drug Administration (FDA) made permanent its guidance to prevent supply shortages in the wake of the Covid-19 pandemic. This included requiring manufacturers to submit a notification at least six months before a product is permanently discontinued.

Also in the news:

google launched a new campaign featuring women entrepreneurs in Africa, including the story of Vivian Nwakah who launched Medsaf, a pharmaceutical supply chain solution to help Nigerians access quality pharmaceutical healthcare.
Pharmaceutical Logistics IQ has launched a new survey with SkyCell to get your perspective on the issues facing pharmaceutical supply chains today and the role hybrid container solutions could play. Share your thoughts with us and enter our draw to win a $100 Amazon gift card.

Get exclusive access to articles, reports, videos, interviews, webinars and other members-only premium content from industry experts and thought leaders by signing up for Pharma Logistics IQ here.

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Generic drugs

Generic Drugs Market 2022 Size, Manufactures, Types, Applications, Opportunities, Challenges and Forecast 2027

Absolute Reports Pvt Ltd

Teva, Novartis – Sandoz, Mylan, Sun Pharmaceutical, Pfizer, Sanofi, Lupin

Pune, March 07, 2022 (GLOBE NEWSWIRE) — Generic drugs market The 2022 Research Report gives experts an analysis of the current global market size estimation, market scenario, structure, products, major industry players, segmentation by types, applications . The Generic Drugs market report covers the dynamics which are having a strong impact on the Generic Drugs market and may also impact its future development. Growth-driving dynamics, market restraints, and recent growths have also been analyzed in the report to provide in-depth industry data.

A generic drug is a pharmaceutical drug that is equivalent to a brand name product in terms of dosage, strength, route of administration, quality, performance, and intended use. The term can also refer to any drug marketed under its chemical name without advertising, or the chemical composition of a drug rather than the brand name under which the drug is sold.

Market competition is not intense. Teva, Novartis – Sandoz, Mylan, Sun Pharmaceutical and Aspen are the industry leaders with approximately 19% market share.

Get a sample copy of the report at – https://www.absolutereports.com/enquiry/request-sample/19859268

North America is the largest consumer location, with a market share of almost 44%. After North America, Europe is the second place of consumption with a market share of 18%.

The global generic drugs market size is expected to reach USD 505790 million by 2027, from USD 281010 million in 2020, at a CAGR of 8.3% during the period 2021-2027.

With industry-standard analytical accuracy and high data integrity, the report brilliantly attempts to unveil major opportunities available in the global Generic Drugs market to help players gain a strong position in the market. Buyers of the report can access verified and reliable market forecasts including those regarding the overall size of the global generic drugs market in terms of revenue.

Market segmentation : –

The Generic Drugs Market report provides an analysis of key trends in each sub-segment of the global Generic Drugs report, with estimates for development at global, regional and country levels and categorized the market based on product type and apps.

Segment by type

  • Order

  • Medicines without a prescription

Segment by application

Inquire or share your questions, if any, before purchasing this report: https://www.absolutereports.com/enquiry/pre-order-enquiry/19859268

The leading companies in the market mainly focus on new ideas associated with the invention and supply of generic drugs. These policies will allow major players to expand their trading boundaries and increase their market position. Here are some of the major players in the Generic Drugs market:

By company

By region

  • North America

  • we

  • Canada

  • Europe

  • Germany

  • France

  • UK

  • Italy

  • Russia

  • Nordic

  • The rest of Europe

  • Asia Pacific

  • China

  • Japan

  • South Korea

  • South East Asia

To understand how the impact of Covid-19 is covered in this report: https://www.absolutereports.com/enquiry/request-covid19/19859268

TOC of Global Generic Drugs Market Size, Status and Forecast 2022

1 Presentation of the report

1.1 Scope of the study

1.2 Market Analysis by Type

1.2.1 Global Generic Drugs Market Size Growth Rate by Type: 2016 VS 2021 VS 2027

1.2.2 Type 1

1.2.3 Type 2

1.3 Market by Application

1.3.1 Global Generic Drugs Market Share by Application: 2016 VS 2021 VS 2027

1.3.2 Request 1

1.3.3 Request 2

1.4 Objectives of the study

1.5 years considered

2 Global Growth Trends

2.1 Global Generic Drugs Market Outlook (2016-2027)

2.2 Generic Drugs Growth Trends by Regions

2.2.1 Generic Drugs Market Size by Regions: 2016 VS 2021 VS 2027

2.2.2 Generic Drugs Historic Market Share by Regions (2016-2021)

2.2.3 Generic Drugs Forecasted Market Size by Regions (2022-2027)

2.3 Dynamics of the generic drugs sector

2.3.1 Generic Drug Market Trends

2.3.2 Generic Drugs Market Drivers

2.3.3 Generic Drugs Market Challenges

2.3.4 Generic Drugs Market Constraints

3 Competition Landscape by Key Players

3.1 Global Top Generic Drugs Players by Revenue

3.1.1 Global Top Generic Drugs Players by Revenue (2016-2021)

3.1.2 Global Generic Drug Revenue Market Share by Players (2016-2021)

3.2 Global Generic Drugs Market Share by Company Type (Tier 1, Tier 2 and Tier 3)

3.3 Players covered: classification by revenue of generic drugs

3.4 Global Generic Drugs Market Concentration Ratio

3.4.1 Global Generic Drugs Market Concentration Ratio (CR5 and HHI)

3.4.2 Global Top 10 and Top 5 Companies by Generic Drugs Revenue in 2020

3.5 Generic Drugs Key Players Head office and Area Served

3.6 Key Players Generic Drug Product Solution and Service

3.7 Date of Entry into the Generic Drugs Market

3.8 Mergers and acquisitions, expansion plans

Generic Drugs Market Research Report Questions Answered:

  • What is the size of the generic drugs market?

  • What are the market driving factors behind the Generic Drugs market?

  • What are the market trends and forecasts for the global Generic Drugs market?

  • What are the trends and forecasts based on market research and analysis of generic drugs market segmentation by type, application, geography?

  • What are the world’s leading generic drug companies?

  • What is the CAGR and revenue expected in the future?

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Generic drugs

Savings on Generic Drugs Continue to Grow, Says Canadian Pharmacy Intermediary SaveRxCanada.to

VANCOUVER, BC, March 3, 2022 /PRNewswire/ — SaveRxCanada.to, a Leading Canadian Pharma Intermediary Since 2002, Continues to See an Uptrend Among Americans buy generic drugs. Generic drugs contain the same active ingredients with the same strength and purity as their brand name counterparts, but at a fraction of the cost.

the Rx Select The SaveRxCanada program was one of the first programs of its kind launched in 2004 to provide access to generic drugs. By adding several international pharmacies to their network, patients were able to find many generic and branded drugs not available in Canada.

The RxSelect program offers free shipping and 5% in rewards points that can be redeemed on future orders.

In United States76 million patients consult at least one prescription drug in 2020.

the 2021 U.S. Generic and Biosimilar Drug Savings Report highlighted the increased cost savings on generic drugs. Some key research findings:

  • $338 billion: US healthcare system savings
  • 90%: Portion of U.S. prescriptions filled with generic drugs
  • $6.61: The average generic share
  • $7.9 billion: savings on biosimilars
  • $109.6 billion: Medicare savings

The savings of individual consumers and the health care system as a whole continue to grow, reaching $338 billion in 2020. Tens of millions of Americans trust their health to generics and biosimilars. These savings are the main component of an often overlooked success story in public health.

About SaveRxCanada.to

SaveRxCanada.to has been a reliable, affordable and reliable Canadian pharmaceutical intermediary for over 18 years.

The company is committed to providing affordable prescription drugs to patients around the world through its network of licensed Canadian pharmacies and international pharmacies.

Visit SaveRxCanada.to to learn more about the company.

Customer service

Toll free: 1-866-799-3435 – Use reference #100048
Monday Friday 9:00 a.m. to 5:00 p.m. (EST)

All orders required a valid prescription from a licensed physician or physician.

This press release was published via 24-7PressRelease.com. For more information, visit http://www.24-7pressrelease.com.

SOURCESaveRxCanada.com

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Generic drugs

Global Multi-Cancer Generic Drugs Market 2021 Manufacturer Landscape, Revenue and Volume Analysis to 2027 – Business Ethics

The research report MarketQuest.bizto Global market for generic drugs for several cancers reviews important industry and market trends, as well as historical and anticipated market data. The research has implications for the stock market as well as other terms and definitions. Analytics promotes its products by application, sort and location in terms of volume and value.

The market accurately reflected the total sales and marketing volume, maximum production and consumption costs, profit margins, import and export, cost structure analysis, in-depth price analysis , vendor landscapes, and other critical market variables. The research helps identify new marketing opportunities and offers a complete picture of the existing global market for generic drugs for multiple cancers.

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The study is significant for organizations or individuals looking to enter the Generic Drugs for Multiple Cancers industry as it provides detailed qualitative and quantitative insights. It also examines how changing patterns, COVID-19, and inflation are affecting market growth. Additionally, supply chain analysis, profit margin analysis, and price research are all covered in depth to help businesses and give them an estimate of how much money they will need to join this market.

Market segmentation based on region:

  • North America (United States, Canada and Mexico)
  • Europe (Germany, France, UK, Russia, Italy and Rest of Europe)
  • Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia)
  • South America (Brazil, Argentina, Colombia and rest of South America)
  • Middle East and Africa (Saudi Arabia, United Arab Emirates, Egypt, South Africa and Rest of Middle East and Africa)

Player Market Segmentation:

  • Pfizer
  • GlaxoSmithKline
  • Novartis
  • Merck
  • Celgene
  • Teva pharmaceutical
  • Mylan
  • Aurobindo Pharmacy
  • Hikma Pharmaceuticals
  • rock
  • Redsenol

Segment the market by product type:

  • Cytotoxic drug
  • Non-cytotoxic drugs

Market segmentation based on application

  • Hospital pharmacy
  • Retail pharmacies
  • Online pharmacies

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In addition, a framework of study has been created to emphasize future events and possibilities in the global Generic Multiple Cancer Drugs industry in recent years. According to the research study, the market will face a variety of drivers and restraints, opportunities and challenges throughout the forecast period. The report also examines the geographical characteristics of the market, which will impact its growth from 2021 to 2027.

Report customization:

This report can be customized to meet customer requirements. Please contact our sales team ([email protected]), who will ensure that you get a report tailored to your needs. You can also get in touch with our executives at +1-201-465-4211 to share your research needs.

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Generic drugs

Generic Drugs Market Continues to Grow Due to Rising Incidence of Chronic Diseases Worldwide | Teva Pharmaceutical Industries, Mylan NV, Novartis International AG, Pfizer, Inc.

Market Overview:

Generic drugs are those that have the same active chemical substance as a brand name drug. Before generics became available, generic drugs were made using identical active ingredients, the only difference being the chemical makeup or dosage. Generic drugs can be sold without any authorization from the Food and Drug Administration. Generic drugs can also be manufactured and approved at the same time as the patented drug if the company that holds the patent for the drug can meet the necessary requirements. Once these requirements are met, a generic drug can be marketed. Generic drugs, however, are not available without a doctor’s prescription because generic drugs lack the safety offered by brand name drugs.

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Key Market Drivers:

Rising cases of chronic diseases across the world is the major factor that is expected to drive the growth of the global generic drugs market. For example, according to the World Health Organization, approximately 422 million people worldwide have diabetes and approximately 1.6 million deaths are directly related to diabetes each year. Generic drugs are manufactured using the same facilities and methods as brand name drugs. In fact, it is usually the same product created with the same quality and consistency. However, generic drugs are manufactured to meet or exceed the safety and efficacy requirements of the United States Food and Drug Administration. Generic drugs can be sold without the need for an expensive marketing campaign because generic drugs can be manufactured at lower prices than brand name drugs. Increase in product launches by major market players is estimated to propel the growth of the global generic drugs market.

Covid-19 impact analysis:

The rising incidence of COVID-positive cases globally has significantly affected the growth of the global generic drugs market. For example, according to Springer, in April 2020, the number of individuals infected with SARS-CoV-2 was approximately 0.9 million with a fatality rate of approximately 1.38%. Additionally, increasing transportation restrictions and lockdown restrictions in several countries has also affected the market growth.

Key points to remember:

  • The global generic drugs market size was valued at around US$263 billion in 2020 and at a CAGR of 6.58%, it is estimated to reach around US$385 billion in 2026, owing to the increase in chronic diseases worldwide. For example, according to the International Agency for Research on Cancer, in 2020 the global cancer burden was approximately 19.3 million.
  • North America is expected to hold a major share of the global generic drug market, owing to the growing prevalence of drug manufacturers in the region. For example, according to Pharmapproach, in 2019 the United States generated approximately US$490 billion in revenue.
  • Asia-Pacific is expected to experience high growth in the global generic drug market, owing to the growing prevalence of pharmaceutical companies in developing regions. For example, according to India Briefing, there are over 3,000 pharmaceutical companies in India, along with 10,500 manufacturing units.

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Reasons to Buy this Generic Drugs Market Report

➡ Save time conducting entry-level research by identifying the size, growth and key players in the emerging Generic Drugs market

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➡Key Company Profiles Reveals Details of Major Generic Drugs Market Players Emerging from Five Transactions and Financial Performance

➡Add weight to presentations and presentations by understanding the future growth prospects of the emerging Generic Drugs market with five-year historical forecasts

➡Compares data from North America, South America, Asia-Pacific, Europe and the Middle East, as well as individual chapters on each region.

Contents

Chapter 1 Industry Overview
1.1 Definition
1.2 Assumptions
1.3 Scope of research
1.4 Market Analysis by Regions
1.5 Generic Drugs Market Size Analysis from 2021 to 2028
11.6 COVID-19 Outbreak: Impact on Generic Drugs Industry

Chapter 2 Global Generic Drug Competition by Types, Applications and Top Regions and Countries
2.1 Global Generic Drugs (Volume and Value) by Type
2.3 Global Generic Drugs (Volume and Value) by Regions

chapter 3 Generation market analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis

Chapter 4 Global Generic Drug Sales, Consumption, Export, Import by Regions (2016-2021)
Chapter 5 North America Generic drugs market To analyse
Chapter 6 Analysis of the generic drugs market in East Asia
Chapter 7 Analysis of the generic drugs market in Europe
Chapter 8 South Asia Generic Drugs Market Analysis
Chapter 9 Southeast Asia Generic Drugs Market Analysis
Chapter 10 Analysis of the generic drugs market in the Middle East
Chapter 11 Analysis of the generic drugs market in Africa
Chapter 12 Analysis of the Generic Medicines Market in Oceania
Chapter 13 Analysis of the generic drugs market in South America
Chapter 14 Company profiles and key figures of the generic drugs sector
Chapter 15 Global Generic Drugs Market Forecast (2021-2027)
Chapter 16 conclusion
Research Methodology

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Generic drugs

FDA OGD Releases Guidance Documents to Accelerate Generic Market Entry | Morgan Lewis – As Prescribed

As the Biden administration and the US Congress continue to debate ways to address perceived concerns about prescription drug prices, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), the FDA has issued approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare and submit abbreviated new drug applications (ANDAs), so generic drugs can gain timely FDA approval and reach the market faster. In January 2022, the FDA released three more guidance documents in the DCAP series.

By helping to make additional generic drugs available at lower prices, the FDA believes this can impact the overall drug price burden. For example, according to the latest Congressional Budget Office (CBO) Reportt, the average net price of a prescription drug in the Medicare Part D and Medicaid programs fell from 2009 to 2018, and this decline “reflects the increased use of cheaper generic drugs.” In the words of the FDADCAP “helps break down barriers to generic drug development and market entry with the goal of driving competition so consumers can get the drugs they need at affordable prices.”

When we asked other departments about the importance of the last three guidelines, Maryll Toufanian, Director of the Office of Generic Drug Policy, replied:

As stated in the DCAP, the FDA understands that it is essential to provide as much transparency as possible in our regulatory expectations. This allows for maximum efficiency for claimants submitting generic drug claims and for our assessment of those claims. Guidance like the one recently released is a key tool in our toolbox to achieve this.

Below is a list of recently released DCAP guidance documents and a brief description of each. Although much of the information has already been provided to industry stakeholders in various forms, it is important for every company considering submitting an ANDA (or has an ANDA pending) to carefully review these published versions of the guidance from the FDA and update their regulatory procedures. Therefore.

REQUESTS FOR INFORMATION AND DISCIPLINE REVIEW LETTERS UNDER GDUFA, GUIDANCE FOR INDUSTRY

Updating a 2017 draft, these final guidelines detail how the DMO will provide ANDA applicants with “preliminary thoughts on possible gaps” after the DMO’s initial assessment for ANDAs submitted between 2018 and 2022 in the under the 2017 Generic Drug User Fee Amendments (GDUFA II). Although future “GDUFA III” legislation will likely change some details, this guidance is also instructive for planning purposes for ANDAs to be filed in 2023 and later.

The guidelines explain that midway through the FDA’s evaluation of an ANDA’s first evaluation cycle (the mid-cycle date), the DMO will issue a Discipline Review Letter (DRL) to ANDA’s applicant to share their preliminary thoughts on a possible application. deficiencies. Alternatively, a Request for Information (RI) can be sent to request additional information or clarification needed to conduct a discipline assessment (eg bioequivalence, labeling or quality). However, these letters will not be sent when the discipline considers that it can act on the ANDA with the information contained in the request.

The use of these letters is intended to provide applicants with the FDA’s thoughts as soon as possible so that they can modify the ANDAs and continue the evaluation process. The FDA hopes that this mid-cycle communication will minimize the number of review cycles needed for approval. Candidates’ responses will not be categorized as a major or minor change to the ANDA and, therefore, will not delay the assessment clock (formerly, the “Exam Clock”), unless the response does not contain information not requested by the FDA or information that requires further evaluation. The letters do not guarantee that a Complete Response Letter (CRL) will not be issued, as the letters reflect feedback from the assessment team, but not feedback from all levels of supervision within other departments.

ANDA SUBMISSION GOOD PRACTICES, INDUSTRY TIPS

In this guide, the OGD highlights common ANDA shortcomings and provides detailed recommendations, so that ANDA applicants can file compliant submissions under GDUFA II and avoid CRLs, data cycles multiple reviews and long approval times. The information is an update of an OGD guide published in 2018 and details the OGD program improvements developed under GDUFA II. By outlining common errors, OGD intends to foster the development of high quality submissions and promote the prompt correction of ANDA deficiencies.

The guidelines cover almost all types of information required in an ANDA, such as patent certifications and exclusivity requirements, labeling, drug substance and drug product descriptions, impurities and intermediates, product quality and manufacturing processes, as well as bioequivalence and dissolution data. Other departments have specific submission and formatting requirements for each eCTD module in all of these areas, so the gap descriptions are helpful and may answer questions that have plagued regulatory affairs staff.

The guide also provides useful information for keeping ANDAs pending, since the initial filing of an ANDA is only the first step to obtaining ANDA approval. During the evaluation cycle, applicants must continually update the information in the ANDA related to many topics, including patent litigation in paragraph IV, orange book changes, manufacturing changes , batch validation and stability data, risk assessment and implementation of mitigation strategy and commercial launch plans. Avoiding submission gaps when submitting updates to a pending ANDA is just as critical as the initial ANDA submission.

ANDA LABELING REVISION FOLLOWING RLD LABELING REVISION, INDUSTRY GUIDANCE PROJECT

These draft guidelines update information that the DMO had previously published in April 2000 via a directive of the same name. Twenty-two years later, FDA reminds ANDA holders of their continued obligation to ensure product labeling is accurate, not false or misleading, and “the same” as the labeling of the corresponding reference medicinal product (RLD). For these reasons, once the FDA approves relevant RLD labeling changes, an ANDA holder should update their labeling “as soon as possible.” To learn about RLD labeling changes, ANDA applicants and ANDA holders should proactively monitor public information, such as the [email protected] web page and the CDER New ListServ.

The DMO also explains that ANDA labeling changes must be organized according to eCTD modules and submitted in electronic format via the electronic submission gateway. An annotated side-by-side comparison of the proposed ANDA labeling and the approved RLD labeling continues to be required.

read more
Generic drugs

FDA OGD Releases Guidance Documents to Accelerate Generic Market Entry

As the Biden administration and the US Congress continue to debate ways to address perceived concerns about prescription drug prices, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), the FDA has issued approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare and submit abbreviated new drug applications (ANDAs), so generic drugs can gain timely FDA approval and reach the market faster. In January 2022, the FDA released three more guidance documents in the DCAP series.

By helping to make additional generic drugs available at lower prices, the FDA believes this can impact the overall drug price burden. For example, according to the latest report from the Congressional Budget Office (CBO), the average net price of a prescription drug in the Medicare Part D and Medicaid programs fell from 2009 to 2018, and this drop “reflects the increased use of lower cost generic drugs. drugs.” In the words of the FDA, DCAP “helps remove barriers to generic drug development and market entry with the goal of stimulating competition so consumers can have access to the drugs they need. need at affordable prices”.

When we asked other departments about the importance of the last three guidelines, Maryll Toufanian, Director of the Office of Generic Drug Policy, replied:

As stated in the DCAP, the FDA understands that it is essential to provide as much transparency as possible in our regulatory expectations. This allows for maximum efficiency for claimants submitting generic drug claims and for our assessment of those claims. Guidance like the one recently released is a key tool in our toolbox to achieve this.

Below is a list of recently released DCAP guidance documents and a brief description of each. Although much of the information has already been provided to industry stakeholders in various forms, it is important for every company considering submitting an ANDA (or has an ANDA pending) to carefully review these published versions of the guidance from the FDA and update their regulatory procedures. Therefore.

REQUESTS FOR INFORMATION AND DISCIPLINE REVIEW LETTERS UNDER GDUFA, GUIDANCE FOR INDUSTRY

Updating a 2017 draft, these final guidelines detail how the DMO will provide ANDA applicants with “preliminary thoughts on possible gaps” after the DMO’s initial assessment for ANDAs submitted between 2018 and 2022 in the under the 2017 Generic Drug User Fee Amendments (GDUFA II). Although future “GDUFA III” legislation will likely change some details, this guidance is also instructive for planning purposes for ANDAs to be filed in 2023 and later.

The guidelines explain that midway through the FDA’s evaluation of an ANDA’s first evaluation cycle (the mid-cycle date), the DMO will issue a Discipline Review Letter (DRL) to ANDA’s applicant to share their preliminary thoughts on a possible application. deficiencies. Alternatively, a Request for Information (RI) can be sent to request additional information or clarification needed to conduct a discipline assessment (eg bioequivalence, labeling or quality). However, these letters will not be sent when the discipline considers that it can act on the ANDA with the information contained in the request.

The use of these letters is intended to provide applicants with the FDA’s thoughts as soon as possible so that they can modify the ANDAs and continue the evaluation process. The FDA hopes that this mid-cycle communication will minimize the number of review cycles needed for approval. Candidates’ responses will not be categorized as a major or minor change to the ANDA and, therefore, will not delay the assessment clock (formerly, the “Exam Clock”), unless the response does not contain information not requested by the FDA or information that requires further evaluation. The letters do not guarantee that a Complete Response Letter (CRL) will not be issued, as the letters reflect feedback from the assessment team, but not feedback from all levels of supervision within other departments.

ANDA SUBMISSION GOOD PRACTICES, INDUSTRY TIPS

In this guide, the OGD highlights common ANDA shortcomings and provides detailed recommendations, so that ANDA applicants can file compliant submissions under GDUFA II and avoid CRLs, data cycles multiple reviews and long approval times. The information is an update of an OGD guide published in 2018 and details the improvements to the OGD program developed under GDUFA II. By outlining common errors, OGD intends to foster the development of high quality submissions and promote the prompt correction of ANDA deficiencies.

The guidelines cover almost all types of information required in an ANDA, such as patent certifications and exclusivity requirements, labeling, drug substance and drug product descriptions, impurities and intermediates, product quality and manufacturing processes, as well as bioequivalence and dissolution data. Other departments have specific submission and formatting requirements for each eCTD module in all of these areas, so the gap descriptions are helpful and may answer questions that have plagued regulatory affairs staff.

The guide also provides useful information for keeping ANDAs pending, since the initial filing of an ANDA is only the first step to obtaining ANDA approval. During the evaluation cycle, applicants must continually update the information in the ANDA related to many topics, including patent litigation in paragraph IV, orange book changes, manufacturing changes , batch validation and stability data, risk assessment and implementation of mitigation strategy and commercial launch plans. Avoiding submission gaps when submitting updates to a pending ANDA is just as critical as the initial ANDA submission.

ANDA LABELING REVISION FOLLOWING RLD LABELING REVISION, INDUSTRY GUIDANCE PROJECT

These draft guidelines update information that the DMO had previously published in April 2000 via a directive of the same name. Twenty-two years later, FDA reminds ANDA holders of their continued obligation to ensure product labeling is accurate, not false or misleading, and “the same” as the labeling of the corresponding reference medicinal product (RLD). For these reasons, after the FDA approves relevant labeling changes for the RLD, an ANDA holder must update their labeling “as soon as possible.” To learn about RLD labeling changes, ANDA applicants and ANDA holders should proactively monitor public information, such as the [email protected] CDER web page and new mailing list.

The DMO also explains that ANDA labeling changes must be organized according to eCTD modules and submitted in electronic format via the electronic submission gateway. An annotated side-by-side comparison of the proposed ANDA labeling and the approved RLD labeling continues to be required.

read more
Generic drugs

FDA OGD Releases Guidance Documents to Accelerate Generic Market Entry – As Prescribed – 02

As the Biden-Harris administration and the US Congress continue to debate ways to address perceived concerns about prescription drug prices, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), the FDA has issued approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare and submit abbreviated new drug applications (ANDAs), so that generic drugs can gain timely FDA approval and reach the market faster. In January 2022, the FDA released three more guidance documents in the DCAP series.

By helping to make additional low-cost generic drugs available, the FDA believes this can impact the overall drug price burden. For example, according to the latest report from the Congressional Budget Office (CBO), the average net price of a prescription drug in the Medicare Part D and Medicaid programs fell from 2009 to 2018, and this drop “reflects the increased use of lower cost generic drugs. drugs.” In the words of the FDA, DCAP “helps remove barriers to generic drug development and market entry with the goal of stimulating competition so consumers can have access to the drugs they need. need at affordable prices”.

When we asked the OGD about the importance of the last three guidelines, Maryll Toufanian, Director of the Office of Generic Drug Policy, replied:

As stated in the DCAP, the FDA understands that it is essential to provide as much transparency as possible in our regulatory expectations. This allows for maximum efficiency for claimants submitting generic drug claims and for our assessment of those claims. Guidance like the one recently released is a key tool in our toolbox to achieve this.

Below is a list of recently released DCAP guidance documents and a brief description of each. Although much of the information has already been provided to industry stakeholders in various forms, it is important for every company considering submitting an ANDA (or has an ANDA pending) to carefully review these published versions of the guidance from the FDA and update their regulatory procedures. Therefore.

Information Requests and Disciplinary Review Letters under GDUFA, Industry Guidance

Updating a 2017 draft, these final guidelines detail how the DMO will provide ANDA applicants with “preliminary thoughts on possible gaps” after the DMO’s initial assessment for ANDAs submitted between 2018 and 2022 in the under the 2017 Generic Drug User Fee Amendments (GDUFA II). Although future “GDUFA III” legislation will likely change some details, this guidance is also instructive for planning purposes for ANDAs to be filed in 2023 and beyond.

The guidelines explain that midway through the FDA’s evaluation of an ANDA’s first evaluation cycle (the mid-cycle date), the DMO will issue a Discipline Review Letter (DRL) to ANDA’s applicant to share their preliminary thoughts on a possible application. deficiencies. Alternatively, a Request for Information (RI) can be sent to request additional information or clarification needed to conduct a discipline assessment (eg bioequivalence, labeling or quality). However, these letters will not be sent when the discipline considers that it can act on the ANDA with the information contained in the request.

The use of these letters is intended to provide applicants with the FDA’s thoughts as soon as possible so that they can modify the ANDAs and continue the evaluation process. The FDA hopes that this mid-cycle communication will minimize the number of review cycles needed for approval. Candidates’ responses will not be categorized as a major or minor change to the ANDA and, therefore, will not delay the assessment clock (formerly, the “Exam Clock”), unless the response does not contain information not requested by the FDA or information that requires further evaluation. The letters do not guarantee that a Complete Response Letter (CRL) will not be issued, as the letters reflect feedback from the assessment team, but not feedback from all levels of supervision within other departments.

ANDA Submission Best Practices, Industry Tips

In this guide, the OGD highlights common ANDA shortcomings and provides detailed recommendations, so that ANDA applicants can file compliant submissions under GDUFA II and avoid CRLs, data cycles multiple reviews and long approval times. The information is an update of an OGD guide published in 2018 and details the OGD program improvements developed under GDUFA II. By outlining common errors, OGD intends to foster the development of high quality submissions and promote the prompt correction of ANDA deficiencies.

The guidelines cover almost all types of information required in an ANDA, such as patent certifications and exclusivity requirements, labeling, drug substance and drug product descriptions, impurities and intermediates, product quality and manufacturing processes, as well as bioequivalence and dissolution data. Other departments have specific submission and formatting requirements for each eCTD module in all of these areas, so the gap descriptions are helpful and may answer questions that have plagued regulatory affairs staff.

The guide also provides useful information for keeping ANDAs pending, since the initial filing of an ANDA is only the first step to obtaining ANDA approval. During the evaluation cycle, applicants must continually update the information in the ANDA related to many topics, including Paragraph IV patent litigation, Orange Book changes, manufacturing changes , batch validation and stability data, risk assessment and mitigation strategy implementation, and commercial launch plans. Avoiding submission gaps when submitting updates to a pending ANDA is just as critical as the initial ANDA submission.

ANDA labeling revision following RLD labeling revision, draft guidance for industry

This draft guidance updates information that the DMO had previously published in April 2000 via a guidance of the same name. Twenty-two years later, FDA reminds ANDA holders of their continued obligation to ensure product labeling is accurate, not false or misleading, and “the same” as the corresponding reference medicinal product labeling (RLD). For these reasons, once the FDA approves relevant RLD labeling changes, an ANDA holder should update their labeling “as soon as possible.” To learn about RLD labeling changes, ANDA applicants and ANDA holders should proactively monitor public information, such as the [email protected] webpage and the CDER New ListServ.

The DMO also explains that ANDA labeling changes must be organized according to eCTD modules and submitted in electronic format through the electronic submission gateway. An annotated side-by-side comparison of the proposed ANDA labeling and the approved RLD labeling continues to be required.

read more
Generic drugs

Generic Drugs Market Share, Size, Business Opportunity, Supply Chain Analysis, Companies and Forecast Report by 2026

global generic drug market

SHERIDAN, USA, Feb. 22, 2022 /EINPresswire.com/ — IMARC Group’s latest research report, titled “Generic Drugs Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021- 2026”, offers a detailed analysis of the market drivers, segmentation, growth opportunities, trends, and competitive landscape to understand the current and future market scenarios.

The global generic drug market share reached a value of US$386 billion in 2020. Looking ahead, IMARC Group expects the market to show moderate growth during the period 2021-2026. A generic drug is an off-patent drug that is identical to other brand name drugs in terms of effect, form, dosage, intended use, quality, and safety. These drugs can only be manufactured after the brand name drug’s patent has expired. Compared to other branded drugs, these are cheaper and do not require extensive research and testing.

Get Free Sample Copy of Report at – https://www.imarcgroup.com/generic-drug-manufacturing-plant/requestsample

Important Attribute and Report Highlights:
• Detailed global market share analysis
• Market segmentation by therapeutic area, drug delivery and distribution channel.
• Historical, current and projected market size in terms of volume and value
• Latest industry trends and developments
• Competitive landscape for the generic drugs market
• Strategies of key players and product offerings

The global market is mainly driven by the increasing prevalence of chronic diseases such as cardiovascular diseases, diabetes, Alzheimer’s disease and Parkinson’s disease. Additionally, significant growth in the pharmaceutical industry has boosted the growth of the market across the globe. Apart from this, increased expenditure by the government as well as private companies to manufacture generic drugs that can improve the healthcare system has created a positive outlook for the market. Additionally, the growing geriatric population has positively influenced the growth of the market. Additionally, the upcoming patent expiration of many branded drugs is expected to drive the market towards growth.

Key Players Covered in the Generic Drugs Market Research Report:
• Teva Pharmaceuticals Industries Ltd.
• Mylan SA
• Novartis AG
• Pfizer Inc.
• Sun Pharmaceutical Industries Ltd.
• Fresenius SE & Co.
• Lupine Limited
• Endo Pharmaceuticals Inc.
• Aurobindo Pharma Limited
• Aspen Pharmacare Holdings Limited

Do you know more information, contact our analyst at– https://www.imarcgroup.com/generic-drug-manufacturing-plant

Overview of the impact of COVID-19:

We regularly monitor the direct effect of COVID-19 on the market, as well as the indirect influence of associated industries. These observations will be incorporated into the report.

Key Market Segmentation:

Breakdown by therapeutic area:
• Central nervous system
• Cardiovascular
• Dermatology
• Genitourinary/Hormonal
• Respiratory
• Rheumatology
• Diabetes
• Oncology
• Others

Rupture by administration of drugs:
• Oral
• Injectables
• Dermal/Topical
• Inhalers

Breakdown by distribution channel:
• Retail pharmacies
• Hospital pharmacies

Breakdown by region:
• North America (United States, Canada)
• Asia-Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Others)
• Latin America (Brazil, Mexico, others)
• Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, others)

Table of Contents of Generic Drugs Market Research Report:
• Preface
• Scope and methodology
• Abstract
• Introduction
• Global generic drugs market
• SWOT analysis
• Value chain analysis
• Price analysis
• Competitive landscape

Other related reports from the IMARC group:
WiFi chipset market: https://www.imarcgroup.com/wifi-chipset-market
Biometrics Market: https://www.imarcgroup.com/biometrics-market
Bakery Ingredients Market: https://www.imarcgroup.com/bakery-ingredients-market
Plant-Based Meat Market: https://www.imarcgroup.com/plant-based-meat-market
Kidney/Renal Function Test Market: https://www.imarcgroup.com/kidney-renal-function-test-market
Aircraft Seating Market: https://www.imarcgroup.com/aircraft-seating-market
Cochlear implants market: https://www.imarcgroup.com/cochlear-implants-market
Shape memory alloys market: https://www.imarcgroup.com/shape-memory-alloys-market
Submersible pumps market: https://www.imarcgroup.com/submersible-pumps-market
Night Vision Devices Market: https://www.imarcgroup.com/night-vision-devices-market

Who we are:

The IMARC Group is a leading market research firm providing management strategies and market research worldwide. We partner with clients across all industries and geographies to identify their most important opportunities, address their most critical challenges and transform their businesses.
IMARC’s information products include major business, scientific, economic and technological developments for business leaders in pharmaceutical, industrial and high-tech organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverages, travel and tourism, nanotechnology and new processing methods are at the top of the list. company expertise.

Elena Anderson
IMARC Group
+16317911145
write to us here

read more
Generic drugs

Generic Drugs Market – EIN Presswire

generic drugs market report

SHERIDAN, USA, Feb. 22, 2022 /EINPresswire.com/ — IMARC Group’s latest research report, titled “Generic Drugs Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021- 2026”, offers a detailed analysis of the market drivers, segmentation, growth opportunities, trends, and competitive landscape to understand the current and future market scenarios.

The global generic drug market share reached a value of US$386 billion in 2020. Looking ahead, IMARC Group expects the market to show moderate growth during the period 2021-2026. A generic drug is an off-patent drug that is identical to other brand name drugs in terms of effect, form, dosage, intended use, quality, and safety. These drugs can only be manufactured after the brand name drug’s patent has expired. Compared to other branded drugs, these are cheaper and do not require extensive research and testing.

Get Free Sample Copy of Report at – https://www.imarcgroup.com/generic-drug-manufacturing-plant/requestsample

Important Attribute and Report Highlights:
• Detailed global market share analysis
• Market segmentation by therapeutic area, drug delivery and distribution channel.
• Historical, current and projected market size in terms of volume and value
• Latest industry trends and developments
• Competitive landscape for the generic drugs market
• Strategies of key players and product offerings

The global market is mainly driven by the increasing prevalence of chronic diseases such as cardiovascular diseases, diabetes, Alzheimer’s disease and Parkinson’s disease. Additionally, the significant growth in the pharmaceutical industry has boosted the growth of the market across the globe. Apart from this, increased expenditure by the government as well as private companies to manufacture generic drugs that can improve the healthcare system has created a positive outlook for the market. Additionally, the growing geriatric population has positively influenced the growth of the market. Additionally, the upcoming patent expiration of many branded drugs is expected to drive the market towards growth.

Key Players Covered in the Generic Drugs Market Research Report:
• Teva Pharmaceuticals Industries Ltd.
• Mylan SA
• Novartis AG
• Pfizer Inc.
• Sun Pharmaceutical Industries Ltd.
• Fresenius SE & Co.
• Lupine Limited
• Endo Pharmaceuticals Inc.
• Aurobindo Pharma Limited
• Aspen Pharmacare Holdings Limited

Do you know more information, contact our analyst at– https://www.imarcgroup.com/generic-drug-manufacturing-plant

Overview of the impact of COVID-19:

We regularly monitor the direct effect of COVID-19 on the market, as well as the indirect influence of associated industries. These observations will be incorporated into the report.

Key Market Segmentation:

Breakdown by therapeutic area:
• Central nervous system
• Cardiovascular
• Dermatology
• Genitourinary/Hormonal
• Respiratory
• Rheumatology
• Diabetes
• Oncology
• Others

Rupture by administration of drugs:
• Oral
• Injectables
• Dermal/Topical
• Inhalers

Breakdown by distribution channel:
• Retail pharmacies
• Hospital pharmacies

Breakdown by region:
• North America (United States, Canada)
• Asia-Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Others)
• Latin America (Brazil, Mexico, others)
• Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, others)

Table of Contents of Generic Drugs Market Research Report:
• Preface
• Scope and methodology
• Abstract
• Introduction
• Global generic drugs market
• SWOT analysis
• Value chain analysis
• Price analysis
• Competitive landscape

Other related reports from the IMARC group:
WiFi chipset market: https://www.imarcgroup.com/wifi-chipset-market
Biometrics Market: https://www.imarcgroup.com/biometrics-market
Bakery Ingredients Market: https://www.imarcgroup.com/bakery-ingredients-market
Plant-Based Meat Market: https://www.imarcgroup.com/plant-based-meat-market
Kidney/Renal Function Test Market: https://www.imarcgroup.com/kidney-renal-function-test-market
Aircraft Seating Market: https://www.imarcgroup.com/aircraft-seating-market
Cochlear implants market: https://www.imarcgroup.com/cochlear-implants-market
Shape memory alloys market: https://www.imarcgroup.com/shape-memory-alloys-market
Submersible pumps market: https://www.imarcgroup.com/submersible-pumps-market
Night Vision Devices Market: https://www.imarcgroup.com/night-vision-devices-market

Who we are:

The IMARC Group is a leading market research firm providing management strategies and market research worldwide. We partner with clients across all industries and geographies to identify their most important opportunities, address their most critical challenges and transform their businesses.
IMARC’s information products include major business, scientific, economic and technological developments for business leaders in pharmaceutical, industrial and high-tech organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverages, travel and tourism, nanotechnology and new processing methods are at the top of the list. company expertise.

Elena Anderson
IMARC Group
+1 631-791-1145
write to us here

read more
Generic drugs

Bridion’s Generic Drugs Get Mass Approval in Korea


Korean pharmaceutical companies recently obtained generic marketing authorization for Bridion (sugammadex) from MSD, a muscle relaxant antagonist.


As the original drug’s patent expires in April, local drugmakers are expected to engage in fierce competition to sell generic copies, observers said.


Bridion Inj. from MSD Korea. is an agent that reverses neuromuscular blockade induced by general anesthetics during surgery.


The Ministry of Food and Drug Safety said on Friday that JW Pharmaceutical, GC Pharma and Daewoong Pharmaceutical had received Bridion’s generic drug license.


Bridion arrived in Korea in February 2013. During surgery, the injection is used to reverse neuromuscular blockade induced by the general anesthetics Rocuronium Bromide or Vecuronium Bromide.


The government has approved Bridion’s generic drugs since December 29, when Hanlim Pharm won the first license.


Nineteen Bridion generics have won local approval, and half of them are expected to be manufactured at Huons’ third plant in Jecheon, North Chungcheong Province.


Industry watchers said the generic Bridion market will heat up in April.


Bridion’s patent, registered in Korea, is titled “6-mercapto-cyclodextrin derivatives: reversal agents for drug-induced neuromuscular block”. It expires on April 12, 2022.


Korean drugmakers tried unsuccessfully to revoke Bridion’s patent.


CTC Bio sued to invalidate the patent, and Intro Bio Pharma, Hana Pharm, Huons Global, and Chong Kun Dang also sued to invalidate the patent extension, but the court dismissed them all.


No local company has succeeded in invalidating Bridion’s patent, which means that no company has obtained the exclusive right to sell a generic drug for a certain period.


A company that quickly secures the generic drug market with patent expiration should have an advantage. Thus, observers said that market competition among Korean pharmaceutical companies will become severe.

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Generic drugs

Bureau of Generic Medicines 2021 Annual Report

Message from the director

Welcome to the seventh annual report of the Office of Generic Drugs (OGD) of the Center for Drug Evaluation and Research (CDER) of the United States Food and Drug Administration (FDA).

Ensuring that patients who need safe and effective drugs have better access to them is a public health priority for the FDA. As you will read in this report, the priority of access to more affordable medicines goes hand in hand with OGD’s mission to ensure that affordable, high-quality generic medicines are available to the American public. In this report, I am pleased to share with you a snapshot of our successes.

Currently, 90% (9 out of 10) of all prescriptions dispensed in the United States are for generic drugs. To make this possible, the Generic Drug Program approves safe, effective, high-quality drugs and monitors these drugs once they hit the market.

How did we do in 2021?

Last year, the Generic Drug Program approved hundreds of abbreviated new drug applications (ANDAs) and thousands of application supplements. Our office has prioritized the evaluation of generic drug submissions for potential treatments and supportive therapies for patients with COVID-19, approving more than 75 original ANDAs, some in record time,1 and since the start of the pandemic, more than 1,200 supplements. We have funded approximately $20 million in science and generic drug research programs. We published 149 product-specific guidelines for generic drug development, including 54 for more difficult-to-develop complex drugs, to support agency thinking on the most appropriate methodology and evidence needed to support development specific generic drugs.

Innovation has helped ensure public access to more affordable medicines

In 2021, OGD’s scientific and programmatic innovations supported our generic drug evaluation work. For example, we have established the scientific basis to support alternative bioequivalence (BE) approaches for several generic drugs. One such example included a novel in vitro BE approach that directly led to the development, evaluation and approval of the first generic difluprednate (Generic Durezol) ophthalmic emulsion used to treat ocular swelling and pain after eye surgery.

Another innovation came with the approval this year of the first generic paliperidone palmitate extended-release injectable suspension (Generic Invega Sustenna), a long-acting injectable indicated for the acute and maintenance treatment of schizophrenia in ‘adult. The FDA has developed modeling and simulation approaches for pharmacokinetic study designs and BE assessments, which the applicant has used. In yet another example, we approved the first generic complex for injection of ferumoxytol (generic Feraheme), a parenteral (non-oral) iron product that treats iron deficiency anemia. Our scientific investment in product characterization and advanced BE study designs were key to this approval. Another programmatic innovation successfully deployed was increasing the frequency of certain updates from monthly to bi-monthly in the FDA’s electronic Orange Book. This change in the frequency of updates provides even more timely information on listed pharmaceutical products, including their market status.

Scientific and regulatory collaboration has moved the needle

Sally Choe, Ph.D. Director, Bureau of Generic Drugs

Scientific and regulatory collaborations have helped us create new approaches to support generic drug review in 2021.

FDA’s partnership with the University of Maryland and the University of Michigan (the Complex Generics Research Center) has reached thousands of stakeholders around the world with workshops that have stimulated innovative dialogue and generated new insights into science and research crucial to the development of complex generic drugs.

Additionally, the continued implementation of the Competitive Generic Therapy (CGT) pathway established by Congress helped us reach an important milestone in 2021: approving 100 ANDAs designated as CGTs. The CGT pathway for generic drugs helps incentivize market entry of drugs with ‘inadequate generic competition’. This milestone is a sign that the CGT program is achieving its goal – the development and marketing of safe and effective generic drugs in areas of the market that previously had little or no competition.

Globally, 2021 marked the launch of a joint FDA and European Medicines Agency pilot program to provide parallel scientific advice to developers of complex generic drugs. The pilot project allows reviewers from both agencies to simultaneously communicate their views on scientific issues, in real time, to manufacturers working on the development of complex generic drugs. This collaboration can help shorten the time it takes for these important products to gain regulatory approval. The FDA also launched the Global Generic Drug Cluster, the first forum created for major regulatory agencies to increase scientific alignment around topics relevant to generic drug development.

In 2021, despite the unique challenges caused by the ongoing pandemic, OGD continued to innovate and conduct scientific research to advance the generic drug agenda. Today, the generic drug program is stronger than ever and continues to take timely steps to improve access to generic drugs. As always, this is good news for the American public.

Sally Choe, Ph.D.
Director, Bureau of Generic Drugs

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Generic drugs

Inhalation & Nasal Spray Generic Drugs Market Size, Scope, Growth – Teva, Sandoz (Novartis AG), Mylan, Allergan PLC – Sox Sphere

New Jersey, United States,- the Generic Inhalation and Nasal Spray Market The report covers the entire global market scenario including key players, their future promotions, preferred vendors, market shares along with historical data and price analysis. It continues to offer key details on changing dynamics to generate market improving factors. It aims to rationalize the expenses of the company. You can also find the current revenue generation rate and spend score here. The best thing about the Generic Drugs for Inhalation and Nasal Spray market report is the provision of guidelines and strategies followed by leading market players. The investment opportunities in the market highlighted here will be of great help in moving the business forward. Knowing the current state of the market is the most important thing covered here to help big players survive in the cutthroat market.

This Generic Inhalation and Nasal Spray Drugs Market study outlines the economic catastrophe induced by the COVID-19 outbreak, which has affected all sectors of the business. A great global economic loss has occurred due to several industrial closures and loss of income. Here, a high degree of information is offered to assess the market situation.

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Key market observation is conducted to draw key conclusions about the growth of the business. In the Competitive Assessment section, this Generic Inhalation and Nasal Spray Drugs Market report sheds light on the list of manufacturers, market conditions, current trends, company profiles and market innovations. It becomes easy for the market players to seize the right opportunities as this report analyzes the weaknesses and strengths of the various competitors in detail. The regional market as well as applications analyzed here to provide the right business opportunities for the business players. This Generic Inhalation and Nasal Spray Drugs Market report is the perfect blend of customer performance and economic trends to enhance business ideas. It also facilitates the task of the main actors of the company by reducing the risks associated with the activity.

Key Players Covered in the Generic Inhalation and Nasal Spray Market Research Report:

Teva, Sandoz (Novartis AG), Mylan, Allergan PLC, Cipla, Akorn, Apotex, Sun Pharma (Ranbaxy), Nephron Pharma, Beximco Pharma, Hikma (Roxane), XIANJU PHARMA

Generic Inhalation and Nasal Spray Market Segmentation:

By Product Type, the market is primarily split into:

• Corticosteroids
• Bronchodilators
• Combinations
• Decongestant sprays
• Others

By application, this report covers the following segments:

• Asthma
• COPD
• Allergic rhinitis
• Other

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Scope of the Generic Drugs for Inhalation and Nasal Spray Market Report

ATTRIBUTES DETAILS
ESTIMATED YEAR 2022
YEAR OF REFERENCE 2021
FORECAST YEAR 2029
HISTORICAL YEAR 2020
UNITY Value (million USD/billion)
SECTORS COVERED Types, applications, end users, and more.
REPORT COVER Revenue Forecast, Business Ranking, Competitive Landscape, Growth Factors and Trends
BY REGION North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
CUSTOMIZATION SCOPE Free report customization (equivalent to up to 4 analyst business days) with purchase. Added or changed country, region and segment scope.

Geographic segment covered in the report:

The Inhalation & Nasal Spray Generic Drugs report provides information about the market, which is sub-divided into sub-regions and countries/regions. In addition to the market share in each country and sub-region, this chapter of this report also contains information on profit opportunities. This chapter of the report mentions the market share and growth rate of each region, country and sub-region over the estimated period.

• North America (USA and Canada)
• Europe (UK, Germany, France and rest of Europe)
• Asia-Pacific (China, Japan, India and the rest of the Asia-Pacific region)
• Latin America (Brazil, Mexico and rest of Latin America)
• Middle East and Africa (GCC and Rest of Middle East and Africa)

Answers to key questions in the report:

1. Who are the top five players in the Generic Inhalation and Nasal Spray market?

2. How will the generic inhaler and nasal spray market develop over the next 5 years?

3. Which products and applications will capture the lion’s share of the Generic Inhalation and Nasal Spray market?

4. What are the drivers and restraints of the Generic Inhalation and Nasal Spray market?

5. Which regional market will show the strongest growth?

6. What will be the CAGR and size of the Generic Inhalation and Nasal Spray market throughout the forecast period?

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Our 250 analysts and SMEs offer a high level of expertise in data collection and governance using industry techniques to collect and analyze data on over 25,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise and years of collective experience to produce informative and accurate research.

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Generic drugs

Generic Drug Industry Trends, Share, Size, Growth and Forecast to 2026 – Sox Sphere

According to the latest report of the IMARC group, entitled “Generic Drugs Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026“, the global generic drug market share reached a value of US$386 billion in 2020. Looking ahead, IMARC Group expects the market to show moderate growth over the period 2021-2026. A generic drug is an off-patent drug that is identical to other brand name drugs in terms of effect, form, dosage, intended use, quality, and safety. These drugs can only be manufactured after the brand name drug’s patent has expired. Compared to other branded drugs, these are cheaper and do not require extensive research and testing.

We regularly monitor the direct effect of COVID-19[female[feminine in the market, as well as the indirect influence of associated industries. These observations will be incorporated into the report.

Request a free sample report: https://www.imarcgroup.com/generic-drug-manufacturing-plant/requestsample

Market Trends and Drivers:

The global market is mainly driven by the increasing prevalence of chronic diseases such as cardiovascular diseases, diabetes, Alzheimer’s disease and Parkinson’s disease. Additionally, the significant growth in the pharmaceutical industry has boosted the growth of the market across the globe. Apart from this, increased expenditure by the government as well as private companies to manufacture generic drugs that can improve the healthcare system has created a positive outlook for the market. Additionally, the growing geriatric population has positively influenced the growth of the market. Additionally, the upcoming patent expiration of many branded drugs is expected to drive the market towards growth.

Explore the full report with table of contents and list of figures: https://bit.ly/3AbtDoN

Competitive landscape:

By IMARC Group, Global Generic Drugs Market report also analyzed the competitive landscape of the market with some of the major generic drug manufacturing companies being

Some of these key players include:

  • Teva Pharmaceuticals Industries Ltd.
  • Mylan AG
  • Novartis AG
  • Pfizer Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Fresenius SE & Co.
  • Lupine Limited
  • Endo Pharmaceuticals Inc.
  • Aurobindo Pharma Limited
  • Aspen Pharmacare Holdings Limited

Key Market Segmentation:

Breakdown by therapeutic area:

  • Central nervous system
  • Cardiovascular
  • Dermatology
  • Genitourinary/Hormonal
  • Respiratory
  • Rheumatology
  • Diabetes
  • Oncology
  • Others

Rupture by administration of drugs:

  • Oral
  • Injectables
  • Dermal/Topical
  • Inhalers

Breakdown by distribution channel:

  • Retail pharmacies
  • Hospital pharmacies

Breakdown by region:

  • North America (USA, Canada)
  • Asia-Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
  • Europe (Germany, France, United Kingdom, Italy, Spain, Others)
  • Latin America (Brazil, Mexico, Others)
  • Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, Others)

Main highlights of the report:

  • Market Performance (2015-2020)
  • Market Outlook (2021-2026)
  • Impact of COVID-19 on the market
  • Porter’s Five Forces Analysis
  • Historical, current and future market trends
  • Market drivers and success factors
  • SWOT analysis
  • Market structure
  • Value chain analysis
  • Complete mapping of the competitive landscape

Note: If you need specific information that is not currently covered by the report, we can provide it to you as part of the customization.

About Us

The IMARC Group is a leading market research firm providing management strategies and market research worldwide. We partner with clients across all industries and geographies to identify their most important opportunities, address their most critical challenges and transform their businesses.

IMARC’s information products include major business, scientific, economic and technological developments for business leaders in pharmaceutical, industrial and high-tech organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverages, travel and tourism, nanotechnology and new processing methods are at the top of the list. company expertise.

Contact us

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Generic drugs

U.S. Generic Drugs Market Report 2021: Small

Dublin, 07 Feb. 2022 (GLOBE NEWSWIRE) — The “Generic Drug Market in the United States, by Type (Generic to Small Molecule vs. Biosimilars), by Application, by Mode of Drug Delivery, by Form, by Source, by Distribution The Report Channel, by Region, Competition, Forecast and Opportunities, 2026” has been added to from ResearchAndMarkets.com offer.

The U.S. Generic Drugs Market was valued at USD 70.78 Billion in 2020 and is expected to grow at a CAGR of 9.43% during the forecast period and may reach the market value of USD 126.74 Billion by 2026 .

Factors such as the cost-effective nature of generic drugs and growing demand from developing economies are majorly responsible for this futuristic growth estimate of the generic drugs market in the United States over the next five years. Generic drugs do not require extensive research and development as in the case of prescription drugs and patent drugs.

Market players and research institutes are investing heavily in patented pharmaceuticals. Moreover, FDA approvals for generic drugs are not required as generic drugs contain the same composition as that of the previously patented drug and thus support the growth of the generic drug market in the United States over the next five years . The healthcare industry in the United States, in terms of generic drugs, has gone from an 80% growth in 2020 to a previous growth of 20% in 2015.

The increase in generic drug exports to developing economies like Kenya, India, etc. also justifies the growth of the US generic drug market over the next five years.

The US generic drugs market is segmented on the basis of type, drug delivery route, form, manufacturing source, application, company, and regional distribution. Based on type, the market can be divided into generics and small molecule biosimilars. Small molecule generics are expected to register the largest market revenue shares and dominate the market segment over the next five years owing to their simpler and easier manufacturing processes.

When producing small molecule generics, generic drug manufacturers are required to prove that the final product contains the same chemical compounds as the patented drug. With similar functions and pharmacokinetic properties, the generic small molecule is accepted. Additionally, the demand for cost-effective generic drugs is expected to further support the growth of the generic drug market in the United States over the next five years.

Based on applications, the market can be fragmented into cardiovascular diseases, diabetes, neurology, oncology, infectious diseases, and others. Cardiovascular diseases are expected to dominate the market segment while recording the highest market revenue shares over the next five years owing to the increasing cases of cardiovascular diseases in the United States.

Additionally, increased demand for treatment and extended medication protocols is driving the growth of cardiovascular disease sub-segment while sustaining the growth of the generic drug market in the United States over the next five years.

The increase in pharmaceutical research and development for the oncology disease is expected to drive the growth of the oncology sub-segment and drive the growth of the US generic drug market over the next five years.

Major market players in the United States leading the growth of the generic drugs market include:

  • Teva Pharmaceuticals USA, Inc.
  • Pfizer Inc.
  • Sandoz US
  • Endo Pharmaceuticals Inc.
  • Aurobindo Pharma USA, Inc.
  • Abbott Laboratories Inc.
  • Eli Lilly and company
  • Sun Pharma Inc.
  • Lupine Pharmaceuticals, Inc.
  • Zydus Pharmaceuticals USA Inc.

Report Scope:

Years considered for this report:

  • Historical years: 2016-2019
  • Reference year: 2020
  • Estimated year: 2021
  • Forecast period: 2022-2026

Generic Drugs Market in the United States, by Type:

  • Generic Small Molecule
  • Biosimilars

Generic Drugs Market in the United States, by Application:

  • Cardiovascular illnesses
  • Diabetes
  • Neurology
  • Oncology
  • Infectious diseases
  • Others

Generic Drugs Market in the United States, by Mode of Drug Delivery:

  • Oral
  • Parenteral
  • Topical
  • Others

Generic Drugs Market in the United States, by Form:

  • Tablet
  • Capsule
  • Injection
  • Others

Generic drugs in the United States, by source:

  • In-house manufacturing
  • Contract manufacturing organizations

Generic Drugs Market in the United States, by Distribution Channels:

  • Retail pharmacies
  • Online pharmacies
  • Hospital pharmacies
  • Others

For more information on this report visit https://www.researchandmarkets.com/r/3b41r9

  • Generic drugs market in the United States


        
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Generic drugs

Generic Drug Markets Over $125 Billion in the United States, Competition, Forecast and Opportunities, 2026

DUBLIN, February 2, 2022 /PRNewswire/ — The “Generic Drugs Market in the United States, by Type (Small Molecule Generics vs. Biosimilars), by Application, by Mode of Drug Delivery, by Form, by Source, by Distribution Channel, by Region, Competition, Forecast and Opportunity, 2026” report has been added to from ResearchAndMarkets.com offer.

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The generic drug market in the United States has been assessed $70.78 billion in 2020 and is expected to grow at a CAGR of 9.43% over the forecast period and could reach the market value of $126.74 billion by 2026.

Factors such as the cost-effective nature of generic drugs and growing demand from developing economies are majorly responsible for this futuristic growth estimate of the generic drugs market in the United States over the next five years. Generic drugs do not require extensive research and development as in the case of prescription drugs and patent drugs.

Market players and research institutes are investing heavily in patented pharmaceuticals. Moreover, FDA approvals for generic drugs are not required as generic drugs contain the same composition as that of the previously patented drug and thus support the growth of the generic drug market in the United States over the next five years . United States The healthcare industry, in terms of generic drugs, has gone from 80% growth in 2020 to a previous growth of 20% in 2015.

Increased generic drug exports to developing economies such as Kenya, Indiaetc also justifies the growth of the generic drugs market in the United States over the next five years.

The US generic drugs market is segmented on the basis of type, drug delivery route, form, manufacturing source, application, company, and regional distribution. Based on type, the market can be divided into generics and small molecule biosimilars. Small molecule generics are expected to register the largest market revenue shares and dominate the market segment over the next five years owing to their simpler and easier manufacturing processes.

When producing small molecule generics, generic drug manufacturers are required to prove that the final product contains the same chemical compounds as the patented drug. With similar functions and pharmacokinetic properties, the generic small molecule is accepted. Additionally, the demand for cost-effective generic drugs is expected to further support the growth of the generic drug market in the United States over the next five years.

Based on applications, the market can be fragmented into cardiovascular diseases, diabetes, neurology, oncology, infectious diseases, and others. Cardiovascular diseases are expected to dominate the market segment while recording the highest market revenue shares over the next five years owing to the increase in the cases of cardiovascular diseases in United States.

Additionally, increased demand for treatment and extended medication protocols is driving the growth of cardiovascular disease sub-segment while sustaining the growth of the generic drug market in the United States over the next five years.

The increase in pharmaceutical research and development for the oncology disease is expected to drive the growth of the oncology sub-segment and drive the growth of the US generic drug market over the next five years.

The main market players in United States that are driving the growth of the generic drugs market include:

  • Teva Pharmaceuticals United StatesInc.

  • Pfizer Inc.

  • Sandoz US

  • Endo Pharmaceuticals Inc.

  • Aurobindo Pharmacy United StatesInc.

  • Abbott Laboratories Inc.

  • Eli Lilly and company

  • Sun Pharma Inc.

  • Lupine Pharmaceuticals, Inc.

  • Zydus Pharmaceuticals United States Inc.

Report Scope:

Years considered for this report:

Generic Drugs Market in the United States, by Type:

  • Generic Small Molecule

  • Biosimilars

Generic Drugs Market in the United States, by Application:

  • Cardiovascular illnesses

  • Diabetes

  • Neurology

  • Oncology

  • Infectious diseases

  • Others

Generic Drugs Market in the United States, by Mode of Drug Delivery:

  • Oral

  • Parenteral

  • Topical

  • Others

Generic Drugs Market in the United States, by Form:

  • Tablet

  • Capsule

  • Injection

  • Others

Generic drugs in the United States, by source:

Generic Drugs Market in the United States, by Distribution Channels:

  • Retail pharmacies

  • Online pharmacies

  • Hospital pharmacies

  • Others

For more information about this report visit https://www.researchandmarkets.com/r/k9pvax

Media Contact:

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Prescription drugs

In-depth research on emerging growth trends, regional status of major key players, driving factors, business strategies and industry size forecast to 2026 – Bristol City Supporters Trust

The Non-prescription Drugs market report covers the whole scenario of the global market including key players, their future promotions, preferred vendors, market shares along with historical data and price analysis. It continues to offer key details on changing dynamics to generate market improving factors. It aims to rationalize the expenses of the company. You can also find the current revenue generation rate and spend score here. The best thing about the Non-Prescription Drugs market report is the provision of guidelines and strategies followed by leading market players. The investment opportunities in the market highlighted here will be of great help in moving the business forward. Knowing the current market status is the most important thing covered here to help big players survive in the compatiator analysis market.

This Non-Prescription Drugs Market study depicts the economic catastrophe induced by the COVID-19 outbreak, which has affected all sectors of the business. A major global economic loss has occurred due to several industrial closures and loss of income. Here, a high degree of information is offered to assess the market situation.

Get Full Sample PDF Copy of Report: https://www.worldwidemarketreports.com/sample/720473

The report helps to identify the major players in the non-prescription drugs market. It helps to analyze the competitive environment of the Non-Prescription Drugs market, including company overview, company total revenue, market opportunities, value, production sites and facilities , SWOT analysis, product details. The study also reveals the sales, revenue and market share of each market player included in this report for the period 2022-2026. It also helps to determine growth drivers and future prospects for the forecast schedule.

The main key vendors in this market are: Pfizer, Roche, Sanofi, Johnson & Johnson, Merck & Co. (MSD), Novartis, AbbVie, Gilead Sciences, GlaxoSmithKline (GSK), Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly , Teva, Bayer

To understand how the impact of covid-19 is covered in these reports: https://www.worldwidemarketreports.com/covidimpact/720473

By Product Type, the market is primarily split into: Branded Drugs, Generic Drugs

By application, this report covers the following segments: Hospital, Clinic

Regions Covered in the Non-prescription Drugs Market Report 2022:

✤ The Middle East and Africa (GCC countries and Egypt)
✤ North America (United States, Mexico and Canada)
✤ South America (Brazil etc.)
✤ Europe (Turkey, Germany, Russia UK, Italy, France etc.)
✤ Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia and Australia)

Additionally, the report provides an overview of key market drivers, challenges, opportunities, and risks and vendor strategies. Key players are also profiled with their market shares in the discussed Global Non-prescription Drugs Market. Overall, this report covers the historical status, current status and future prospects of the global Non-prescription Drugs Market for 2016-2026.

This Non-Prescription Drugs report provides a superior market perspective in terms of product trends, marketing strategy, future products, new geographic markets, future events, sales strategies, or actions or behaviors of clients. This market research presents actionable market insights with which sustainable and profitable business strategies can be created.

For more information or query or customization before buying: https://www.worldwidemarketreports.com/quiry/720473

Important report features:

✤ Detailed analysis of the Non-Prescription Drugs market
✤ Fluctuating industry market dynamics
✤ Detailed market segmentation
✤ Historical, current and projected market size in terms of volume and value
✤ Recent industry trends and developments
✤ Competitive Landscape of Non-prescription Drugs Market
✤ Strategies of key players and product offerings
✤ Potential and niche segments/regions showing promising growth
✤ A neutral perspective on the performance of the non-prescription drug market.

Report on reasons to buy:

✤ The report analyzes the future growth of the non-prescription drugs market.
✤ To analyze various perspectives of the Non-prescription Drugs market using Porter’s Five Forces Analysis.
✤ Study on which product type is expected to dominate the market and which regions are expected to grow fastest during the forecast period.
✤ To recognize the new developments, Non-Prescription Drugs Market shares, and policies employed by key market players.
✤ Competitive landscape, including Non-Prescription Drugs market share of major players along with key policies accepted for development over the past five years.
✤ Comprehensive company profiles covering product offerings, key financial information, recent developments, SWOT analysis and strategies employed by the leading player in the non-prescription drugs market.

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Generic drugs

Prescribe generic drugs

Notwithstanding the code of ethics of the Medical Council of India and clear government orders regarding the prescription of generic drugs for patients, doctors continue to flout these instructions under pretexts unclear to health administrators who have now demanded prescription audits to check if patients are being prescribed these drugs which are less expensive than general drugs. Generic drugs are drugs created with the same ingredients as brand name drugs. MCI’s recent guideline under Code of Medical Ethics 1.5 states that every physician should, whenever possible, prescribe drugs with generic names and should ensure that there is a prescription and a rational use of drugs. By default, most drugs sold in India are generic. However, they are marketed under a brand given by the manufacturer. This directive transfers the responsibility for the selection of the brand name of the medicine and the manufacturer to the pharmacist, as is the practice in Europe and in many developed countries. This advice is downplayed by the licensed doctors of India, stating that this advice will put the health of the patients in the hands of the pharmacists instead of the doctor. The generic drug must have the same destination as the branded product that serves as its prototype. It relates to the name of the salt or the active ingredient of a drug delivery form. Generic drugs are drugs designed to work exactly the same way as brand name drugs, but are often less expensive. Although not associated with any particular company, generics are generally subject to government regulations in the countries in which they are issued. They are labeled with the manufacturer’s name and a generic nonproprietary name. The directive from MCI or any other regulatory body favoring the writing of generic names only should be carefully evaluated by the clinician practitioner. Patient safety must be of paramount importance. Every effort should be made by professional bodies to achieve syncretism with government regulations based on a thorough understanding of the issues. The solution to the brand versus generic problem lies in strengthening the country’s existing quality control structure. Generic drugs are available at Jan Aushadhi Kendras across Jammu and Kashmir and doctors have to prescribe them to patients. There is a need for awareness among the masses as Kendras are functional in the district while other Kendras are in preparation. The new format regarding “prescription verification” would review collected prescriptions and see if generic drugs are prescribed and preference is given to drugs available free of charge from hospital supplies. It will also check unnecessary tests, diagnoses; procedures and referrals to private/specialist clinics without requirement.

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Prescription drugs

Pfizer, Gilead Sciences, Johnson & Johnson, Roche, AbbV – The Oxford Spokesperson

The Global Prescription drugs The industry report gives a comprehensive report on the global prescription drugs market. Details such as market size, key players, segmentation, SWOT analysis, pestle, carrier 5, most influential trends and business environment are mentioned in this report. Additionally, this report contains tables and figures that give a clear outlook of the prescription drugs market. With the help of this report, an organization can achieve its goals and build its unique strategy. A sample report is available in 20 different formats, so let us know your exact requirements so we can focus on your area.

These are the few market players in this industry-

Pfizer, Gilead Sciences, Johnson & Johnson, Roche, AbbVie, Sanofi, Amgen, Novartis, Merck & Co. (MSD), GlaxoSmithKline (GSK), Bayer, Takeda, AstraZeneca, Takeda, Novo Nordisk, Teva, Bristol-Myers Squibb, Boehringer Ingelheim, Allergan, Eli Lilly

We have recent updates from the Prescription Drugs Market in sample copy @ https://www.maccuracyreports.com/report-sample/91238

prescription drug market

Hospital, Clinic, Other.

Application as below

Brand drugs, generic drugs.

Fundamental is well established in the important study. The report features up-to-date data on product details, roadmap, investment strategy, revenue figures and sales of major companies. In addition, the details also give the global prescription drugs market revenue and its forecast. Business model strategies of key companies in the Prescription Drugs market are also included. The key strengths, weaknesses and threats shaping the major market players have also been included in this research report. You can make a plan just by looking at this market research.

Browse Full Report with Facts and Figures of Prescription Drugs Market Report at @ https://www.maccuracyreports.com/reportdetails/reportview/91238

MR Accuracy Reports has published the report which gives a detailed overview of the key segments of the market. Both fastest and slowest growing market segments are covered in this report. Key emerging opportunities of the fastest growing global prescription drug market segments are also discussed in this report. The market size, share and forecast of each segment and sub-segment are available in this report. Additionally, the region segmentation and trends driving the major geographic region and emerging region have been presented in this report.

Regional assessment and diversification of segments.

North America (United States, Canada, Mexico)
Europe (UK, France, Germany, Spain, Italy, Central and Eastern Europe, CIS)
Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific)
Latin America (Brazil, Rest of LA)
Middle East and Africa (Turkey, GCC, Rest of Middle East)

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The research team has gathered the study on the Global Prescription Drugs Market and also presents a history of the tactical activities of mergers, acquisitions, collaborations and partnerships in the market. Senior analysts’ valuable recommendations on strategic investment in research and development can help new entrants or established players to penetrate emerging sectors of the Prescription Drugs Market. Investors will get a clear insight into the dominating players in this industry and their future predictions. Additionally, readers will get a clear perspective on the high demand and unmet consumer needs that will drive the growth of this market. This material has been very useful for all TOP players.

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Generic drugs

Billionaire Mark Cuban launches online pharmacy with generic drugs at affordable prices

Last week, tech entrepreneur, shark tank Dallas Mavericks investor and owner Mark Cuban has entered the competitive race for billionaire-class philanthropy by launching an online health marketplace offering generic drugs at affordable prices. But his new business is not a charity. The new digital pharmacy called Mark Cuban Cost Plus Drug Company (MCCPDC) promises to sell drugs at drug prices plus a 15% markup and a $3 pharmacist fee. Shipping is an additional $5. At launch, the website sells over 100 drugs, and although insurance is not accepted by society, many of these drugs are priced below what people would pay even with insurance.

“The price of generic drugs is ridiculous. End of the period of history,” Cuban said Forbes by email.

The pharmacy’s website, costplusdrugs.com, further explains its mission of affordability and transparency. “We started Mark Cuban Cost Plus Drug Company because every American should have access to safe and affordable drugs. If you don’t have insurance or have a high deductible plan, you know that even the most basics can cost a fortune. Many people spend crazy amounts of money every month just to stay healthy. No American should have to suffer or worse, because they can’t afford basic medicines. prescription,” Cuban wrote on the site.

At launch, drugs for conditions ranging from cancer to high cholesterol, HIV, diabetes, and more. are available for sale, and the company plans to expand its offering. “We’ll add them as soon as possible,” Cuban tweeted to someone asking about a drug that wasn’t initially available on the market. He also noted that they’re “building a factory in Dallas so we can make our own injectables. [sic] And if costs go down, prices will go down too, although they intend to stick to that 15% markup. “If others beat our prices, we rejoice,” Cuban said on Twitter.

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Generic drugs

Generic Inhalation and Nasal Spray Market Valuation to Grow at a Healthy CAGR through 2027

The Global Generic Drugs for Inhalation and Nasal Spray Market Forecast Report 2020-2027 presents a precise breakdown of the industry based on type, applications, and research regions. The growth strategies adopted by these companies are studied in detail in the report. The Market size section gives the Generic Inhalation and Nasal Spray Drugs market revenue, covering both historical market growth and future forecast.

The report provides detailed information regarding the industry vertical. The assessment is based on the dual perspective of production and consumption.

Talking about the production aspect, the study elaborates on the manufacturing of the product, the remuneration of the product and the gross margins of the companies manufacturing the product. Although based on consumption, the study focuses on the consumption value of the product and the consumption volume of the product as well as the import and export status of the product.

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A brief overview of the regional landscape:

Regional segmentation: North America, Europe, Asia-Pacific, Middle East and Africa, Latin America.

Details mentioned in the section

The report offers a detailed breakdown of the regional terrain of this industry.

An overview of the product range:

Generic Drugs for Inhalation and Nasal Spray Market Report Segment by Types:

  • Corticosteroids
  • Bronchodilators
  • Combinations
  • Decongestant sprays and others

An overview of the field of application:

Generic Drugs for Inhalation and Nasal Spray Market report segmented by Application:

  • Asthma
  • COPD
  • Allergic rhinitis
  • Others
  • By region
  • North America
  • we
  • Canada
  • Europe
  • Germany
  • France
  • UK
  • Italy
  • Russia
  • Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • Taiwan
  • Indonesia
  • Thailand
  • Malaysia
  • Philippines
  • Vietnam
  • Latin America
  • Mexico
  • Brazil
  • Argentina
  • Middle East and Africa
  • Turkey
  • Saudi Arabia
  • United Arab Emirates
  • By company
  • Suits you
  • Sandoz (Novartis SA)
  • Mylan
  • Allergan PLC
  • cipla
  • Akorn
  • Apotex
  • Sun Pharma (Ranbaxy)
  • Nephron Pharma
  • Beximco Pharma
  • Hikma (Roxane) and XIANJU PHARMA

Major Key Players of the Global Generic Inhalation and Nasal Spray Market are:

  • Teva Sandoz (Novartis AG) Mylan Allergan PLC Cipla Akorn Apotex Sun Pharma (Ranbaxy) Nephron Pharma Beximco Pharma Hikma (Roxane) XIANJU PHARMA

Details mentioned in the section

The research report offers a competitive spectrum analysis of the Inhalation & Nasal Spray Generic Drugs Market.

Data provided in the study:

  • The report provides information on business profiles of companies.
  • The products manufactured by these companies are also provided in the report.
  • Information regarding product specifications and applications are provided in the report.

The research provides data related to these companies’ growth margins as well as manufacturing expenses, product costs, and compensation.

The Generic Inhalation and Nasal Spray Drugs Market report provides data related to the extent to which the industry has been assessed. The report contains information on the analysis of the feasibility of new investment projects as well as the research conclusions of the studies.

Generic Inhalation and Nasal Spray Industry Highlights:

  • Generic Inhalation and Nasal Spray Market Share by Major Players: Here, the capital, revenue and price analysis by the company is included along with other sections such as expansion plans, assisted areas, products offered by major manufacturers, alliance and l acquisition and delivery of the seat.
  • Global Growth Trends: Industry trends, growth proportion of major producers, and production analysis are the segments included in this chapter.
  • Market Size by Application: This segment includes Inhalation & Nasal Spray Generic Drugs market consumption analysis by application.
  • Generic Inhalation and Nasal Spray Market Size by Type: It includes analysis of value, product utility, market percentage, and production market share by type.
  • Manufacturer Profiles: Here, leading players of the global Generic Inhalation and Nasal Spray market are studied based on sales area, key products, gross margin, revenue, price, and production.
  • Value Chain and Sales Channel Analysis of Generic Inhalation and Nasal Spray Market: It includes analysis of customers, distributors, market value chain and sales channels.
  • Market forecast: This section is obsessed with production and production value forecast, forecast of major producers by type, application and regions

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Generic drugs

Mark Cuban’s drug company launches pharmacy, promising huge savings on generic drugs

Mark Cuban Cost Plus Drug Company (MCCPDC) has launched its online pharmacy as part of an ongoing effort to provide consumers with drugs at low prices.

The pharmacy claims to offer significant savings, with several prescription drugs costing more than half the price of the next most affordable option. For example, imatinib for the treatment of leukemia has a retail price of $9,657 per month, according to the MCCPDC, compared to $120 with a common voucher. Its price through the new company, however, is only $47 per month.

The initial launch of the pharmacy inventory consists of 100 generic drugs.

The MCCDPC aims to circumvent so-called middlemen and markups and boasts of reflecting actual manufacturer prices with a fixed 15% fee. To avoid working with pharmacy benefit managers, the pharmacy will be cash only. The pharmacy is powered by Truepill’s digital health platform and leverages its nationwide pharmaceutical footprint to fill and deliver prescriptions.

“We will do whatever it takes to bring affordable pharmaceuticals to patients,” Alex Oshmyansky, CEO of Mark Cuban Cost Plus Drug, said in an announcement. “The mark-up on potentially life-saving medicines that people depend on is an issue that cannot be ignored. It is imperative that we act and help expand access to these medicines for those who need them most.”

RELATED: 2 New PBM Launches Aim to Bring Greater Transparency to the Market

In November, the MCCPDC launched its own Pharmacy Benefits Manager and pledged to be transparent about the costs it pays for drugs with those who work with it. With this venture, he hopes to completely eliminate the traditional PBM model.

The company plans to integrate its pharmacy and wholesaler with its PBM so that PBM customers have access to wholesale pricing through the pharmacy. Its Dallas pharmaceutical plant is expected to be built by the end of this year.

“There are many bad actors in the pharmaceutical supply chain that prevent patients from getting affordable medicines,” Oshmyansky said. “The only way to guarantee affordable prices is to integrate vertically.”

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Generic drugs

Generic Drugs Market Segmentation, Analysis by Recent Trends, Development by Region to 2030 Abbott Laboratories, Allergan, Inc., Alvion Pharmaceuticals PC, Amneal Pharmaceuticals, Inc

The Global Generic Drugs Market Report is a compilation of in-depth research studies on various aspects of the Generic Drugs Market. With precise data and highly authentic information, it brilliantly attempts to deliver a real and transparent picture about the current and future situations of the global Generic Drugs Market. Market players can use this powerful tool to create effective business plans or make significant changes to their strategies. The report discusses the growth of global and regional markets. It also sheds light on the high growth segments of the global generic drugs market and their development in the coming years.

Key players operating in the global generic drugs market include: Abbott Laboratories, Allergan, Inc., Alvion Pharmaceuticals PC, Amneal Pharmaceuticals, Inc., Aspen Pharmacare Holdings Limited., AstraZeneca plc., Cipla Inc., Dr. Reddy’s Laboratories Ltd., Egis Group, Eli Lilly and Company, Endo International plc , Fresenius Kabi Kabi SwissBioSim GmbH, Gedeon Richter Ltd, Gilead Sciences, Inc., GlaxoSmithKline Plc., Lupine Pharmaceuticals, Inc., Mylan NV, Novartis International AG, Pfizer Inc., STADA Arzneimittel AG, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries Ltd .

Request a sample PDF copy of this report from: https://www.absolutemarketsinsights.com/request_sample.php?id=603

Global Generic Drugs Market was valued at USD 284.56 Billion in 2018 and is projected to reach USD 472.32 Billion by 2027, growing at a CAGR of 5.8% over the forecast period.

The study of the generic drugs market follows a combination of in-depth research and structured methodology. These methods probe the market from different angles to find suitable analyses. However, on a general scale, data is gathered from a variety of trusted sources such as vendor listing, product and research papers, manufacturer processes, and many more. Every market research is given the exact same careful shadow that makes it valuable reading.

The Generic Drugs market report categorized the market into segments comprising product type and application. Each segment is assessed based on its share and growth rate. In addition, analysts have studied potential regions that could prove valuable for manufacturers in the years to come. The regional analysis includes reliable forecasts of value and volume, helping market players to gain in-depth knowledge about the entire industry. In addition, the Generic Drugs market study revolves around the development of regional trends, preferred marketing channels, long-term stability, and environmental analysis. It also contains product capabilities, price, earnings status, demand, production and market growth and a trajectory of future forecasts.

If you have any questions/requests, ask our expert: https://www.absolutemarketsinsights.com/enquiry_before_buying.php?id=603

Impact of COVID-19:

This study presents insights into COVID-19 in consumer behavior and changing demand, buying habits, supply chain reorganization, market force dynamics, and substantial involvement of the government. The new research provides insights, analysis, estimates and forecasts considering the effect of COVID-19 on the markets.

Reasons to buy the report:

  • The study details the generic drugs market with a detailed market breakdown in terms of volume, size and value across all sectors.
  • A comprehensive breakdown of the Generic Drugs market supported by graphs, pie charts, and figures aids understanding.
  • A projected forecast of the generic drugs market is expected to be extracted from real-time data points which are a compilation of 2016 to current data.

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Global Generic Drugs Market Segmentation:

By type

  • Prescription products
  • Over-the-counter (OTC) products

By app

  • Respiratory
  • Dermatology
  • Oncology
  • Diabetes
  • Infectious diseases
  • Ophthalmology
  • women’s health
  • Central nervous system (CNS)
  • Cardiovascular
  • Urology
  • Others (pain management, etc.)

By form

  • Tablets
  • capsules
  • Injectables
  • Topical creams
  • Others

By distribution channel

  • Retail pharmacy
  • Hospital pharmacy

By region:

  • North America [U.S., Canada, Mexico]
  • Europe [Germany, UK, France, Italy, Rest of Europe]
  • Asia Pacific [China, India, Japan, South Korea, Southeast Asia, Australia, Rest of Asia Pacific]
  • South America [Brazil, Argentina, Rest of Latin America]
  • Middle East and Africa [GCC, North Africa, South Africa, Rest of the Middle East and Africa]

For more information, click on: https://www.absolutemarketsinsights.com/reports/Generic-Drugs-Market-2019-2027-603

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Phone: IN +91-740-024-2424, US +1-510-420-1213
Contact Name: Shreyas Tanna
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Generic drugs

Growing controversy over ‘skinny’ generic drug labeling

The vast majority of patients who started treatment with imatinib for gastrointestinal stromal tumors (GISTs) received a generic drug that did not have FDA approval for this indication, a large retrospective review showed.

Almost half of the 2,000 patients in the imatinib initiators review had chronic myeloid leukemia (CML), while about a third had GIST. Three years after the introduction of generic imatinib, more than 90% of patients in both groups received the generic, which had a label indication for CML but not for GISTs, reported Bryan S. Walsh, JD , from Brigham and Women’s Hospital and Harvard Medical School in Boston

Overall, 85% of patients with CML, GIST or another condition were initiated on a generic version of imatinib, the group wrote in the Journal of Clinical Oncology.

The findings highlight the FDA-approved practice of “skinny labeling,” which allows generic manufacturers to market their labels that include covered indications, such as the CML for generic imatinib, but exclude indications still under patent protection. Skinny labeling is at the center of legal disputes between patent-holding brand-name drug companies and generic makers, Walsh said. MedPage today.

The skinny label has its origins in the Hatch-Waxman Amendments which established an approval pathway for generic drugs, including the Abbreviated New Drug Application.

“The goal is to prevent the delay of generic drug approvals as a result of a drug gaining subsequent approvals for new diseases after the initial approved indication,” Walsh said. “If a manufacturer were to get another disease approved for their drug, they would get another patent [that would extend exclusive marketing rights]. Thin labels allow generic manufacturers to avoid [patented-protected indications] and come to market timely. »

Generic approvals with thin labeling have become increasingly common in recent years. In a previous study, Walsh and colleagues identified 56 brand name drugs with newly approved generics between 2015 and 2019 with lean labeling sensitivity, 24 of which were approved with lean labels. In the year prior to first generic approval, median net sales of branded drugs with full-size generics were $522 million, while median net sales of branded drugs with small-label generics were $522 million. $852 million.

In the current study, Walsh and colleagues examined the impact of lean labeling by means of indication-specific imatinib uptake. They identified patients covered by private insurance or Medicare Advantage plans who started imatinib from February 2016 (when the first generic became available) to September 2020. Generic versions of imatinib approved during this period had thin labels that included indications for CML but excluded GISTs.

Of the 2,000 patients included in the analysis, 934 (47%) started imatinib for an indication of CML, 686 (34%) for GIST and 380 (19%) for other or unknown indications. Generic use increased throughout the study period, surpassing 80% across all diagnostic groups in January 2017, one year after the first generic became available.

After adjusting for differences in patient characteristics, generic use at initiation was slightly but significantly higher in patients with CML than in those with the patented indication of GIST (88% versus 85%; HR 0.56, 95% CI 0.39-0.80, P

The median copayment for a 30-day supply of generic imatinib was $7 versus $40 for brand name imatinib (Gleevec). Co-payments for generic imatinib were highest for patients with low-income, unsubsidized Medicare Advantage plans ($162) and lowest for patients with commercial insurance ($0). Median copayments for brand name imatinib ranged from $1,730 for Medicare without low-income subsidy to $0 for high-deductible commercial insurance plans.

“These results really put the difference in median copays into perspective,” Walsh said. “If you compare a median copayment of $7 for a generic with a median copayment of $40 for the brand name drug, that’s a big gap for a one-month prescription. It’s kind of the key point here. [Skinny labeling] makes drugs more affordable for patients.”

A closely watched legal battle centered on skinny labeling could have a game-changing effect on the future of skinny labels. Last year, a federal appeals court ruled that generic maker Teva infringed GlaxoSmithKline’s patent protection for the cardiovascular drug carvedilol (Coreg) and reversed a $235 million court ruling. Legal wrangling continues in this case, but other potential plaintiffs and defendants have taken notice.

“We’re starting to see some sort of knock-off cases going through the lower courts,” Walsh said. “In one case, it’s not a generic manufacturer that’s being sued but a health insurer, based on their form. It’s going to be interesting to watch and see how the courts deal with a new type of defendant.”

To preserve the beneficial effects of lean labeling, federal regulators should take the lead in providing guidance, Walsh and coauthors said.

“[The carvedilol case] posed a threat to the lean labeling pathway, as it could discourage generic manufacturers from using this approach to introduce timely generic competition,” they wrote. “To optimize the use of the lean labeling pathway and protect generic manufacturers, the FDA and U.S. Patents Trademark Office should provide better guidance to manufacturers on how to legally market generics labeled lean, and the FDA should provide a public list of branded products that may qualify for lean labeling. »

  • Charles Bankhead is editor for oncology and also covers urology, dermatology and ophthalmology. He joined MedPage Today in 2007. To follow

Disclosures

The study was supported by the Commonwealth Fund and Arnold Ventures.

Rome reported honoraria from Blue Cross and Blue Shield of Massachusetts and research funding from the Anthem Public Policy Institute.

Walsh said he has no relevant relationship with the industry.

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Generic drugs

Bicol consumers urged to buy generic drugs

Department of Health-Centre for Health Development Regional Office Bicol (PNA file photo)

TOWN OF LEGAZPI – Bicol’s Department of Health-Center for Health Development (DOH-CHD) in Bicol reported Wednesday that pharmacies in the area have an adequate supply of medications for flu-like symptoms.

During a press conference, Bicol CHD regional manager Dr. Ernie V. Vera said that although there is a shortage of brand name paracetamol in some pharmacies, generic drugs including paracetamol are always available.

“Branded and generic drugs have the same effect despite price differences,” he said.

Vera also encouraged the public to support the use of generic drugs.

The Bicol DOH-CHD also conducted a rapid survey of area pharmacies to identify the supply status of paracetamol and other flu medications.

“The survey results show that of the 123 respondents, 23 said they were out of paracetamol while 14 out of 23 said they were out of other flu medication,” said said Noemi Bron, DOH-5 health promotion and education manager. in an interview.

Bron added that Bicol DOH-CHD discourages the practice of panic buying, hoarding and self-medication.

“In case of symptoms, it is strongly advised to consult a doctor before buying medication,” she said. (ANP)

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Generic drugs

New study shows new strategy to improve generic drug quality control


Read the article

Chinese researchers have developed a new assessment strategy that can be used to check the quality of generic drugs developed through various processes. The strategy is likely to improve regulatory and decision-making aspects related to pharmaceutical products.

The study, led by Professor Changqin Hu of the National Food and Drug Control Institute and Professor Xiaomei Ling of Peking University, was published in the Pharmaceutical Analysis Journal. This article was posted on November 4, 2020 and was published in Volume 11, Issue 5 of the journal on October 31, 2021.

The researchers designed their study to align with current Good Manufacturing Practice quality standards that emphasize the “QbD” concept instead of the traditional “quality by test” approach.

Prof. Hu explained, “According to the QbD concept, the quality of drugs can be maintained by ensuring the quality at every step of the design, development and manufacturing process. To develop an evaluation strategy that would assess the commonalities between the different generic drug development processes, we sought to define universal indicators and methods to characterize the different processes used for the same pharmaceutical product.

A range of information related to drug development processes has been documented and available in NESTP and other publications, serving as a resource for designing the desired computational model for quality assessment. Based on this information, the researchers developed an assessment process called “population pharmaceutical quality assessment” to extract process information related to sample population quality and study the intrinsic links between the samples. QbD elements. The strategy thus formulated has proven to be suitable for assessing the quality and risks of the pharmaceutical process.

Prof. Ling explained, “Our method has provided a scientific tool to objectively and comprehensively assess the consistency of quality and promote the regulatory status of domestic generic drugs.

To demonstrate the applicability of the new strategy, the researchers performed a consistency assessment of the quality of generic ceftriaxone sodium injections and a risk assessment of the process and monitoring trends in the quality of the injections population. generic aztreonam. Both evaluations gave satisfactory results.

“The newly developed method has emerged as an efficient and cost-effective way to improve product quality by uncovering key issues in drug quality assessment through data mining. In addition, the method would likely facilitate the timely prediction of various hidden but preventable quality risks, serving the regulatory perspective, ”said Dr Zhao.

The researchers hope that by taking advantage of the continued addition of data to the knowledge base, they can further improve their strategy for superior decision-making regarding drug regulation.

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Generic drugs

Dabawenyos accumulates brand-name paracetamol but supply of generic drugs is stable

DAVAO CITY (MindaNews / Jan 08) – Pharmacies here are running out of branded paracetamol due to hoarding, but the Davao chapter of the Pharmacists Association of the Philippines (PPHA) has assured the public that the supply of generic drugs remained stable.

PPHA Davao President Dr Kenny James Merin told a virtual reporter on Friday that Dabawenyos may no longer be able to buy branded paracetamol at local pharmacies due to fears over the threat of the variant. Omicron in the country triggered panic buying behavior. .

“Don’t panic, buy. If you buy when you don’t need it, those who really need paracetamol won’t be able to buy, ”he added.

The city predicts an increase in coronavirus cases by the third or fourth week of this month due to holiday gatherings.

As of January 7, the Department of Health (DOH) -Davao reported 99 new cases, bringing the total number of cases to 54,124 with 243 active, 52,088 recovered and 1,793 dead.

Merin said some pharmacies may run out of stocks of branded paracetamol, but told the public there is no need to panic buying because they can still get generic drugs.

Merin said the generic drugs are as effective as their branded counterparts.

These days, he said, many customers buy paracetamol in boxes.

“Rest assured that our pharmacies are replenishing their stocks. We have generic or alternative brands of our paracetamol. So those who need it, they can always get paracetamol, ”he said.

He added that pharmacies have been instructed to limit each customer’s purchase to one or two tampons pending replenishment of stocks “to ensure that everyone in our community will have access to paracetamol if they have any. need, especially for those with flu or flu-like symptoms.

“Currently, the stock level of our paracetamol is really low. Why is that? In every business we have what is called inventory leveling and it will be depleted by the sudden increase in demand. It doesn’t mean that we can’t look for stocks anymore, ”he said.

He said they expect more stocks of paracetamol to arrive in the city in the coming weeks.

He warned the public to be cautious in purchasing paracetamols online and at other stores amid the proliferation of counterfeit drugs.

“Buy only from legitimate pharmacies. Do not buy in other stores without a pharmacist because you are putting yourself in danger. If you buy from legitimate pharmacies, you can rest assured that their generic drugs are as effective as brand name drugs, ”he said.

He added that the Food and Drugs Administration (FDA) recently warned against the proliferation of counterfeit drugs.

He said counterfeit drugs can cause serious health problems.

“Don’t compromise your security. The selling price of online sellers will no longer matter, because what matters is whether they have the power to sell. If they are not regulated by the FDA, it only means that the quality of their product is not verified, ”he added. (Antonio L. Colina IV / MindaNews)

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Generic drugs

More NJ seniors are now eligible to buy $5 generic drugs and $7 brand name drugs under PAAD

More low-income New Jersey seniors qualify for discounted pharmaceutical drugs after the state raised its income threshold in two of its longstanding subsidy programs, the administration said Thursday. of Governor Phil Murphy.

The change means, in part, that people 65 and older who earn less than $38,769 a year could buy generic drugs for $5 and brand name drugs for $7, officials said.

“Few issues have a greater financial impact on New Jersey families than the ever-escalating cost of prescription drugs,” Murphy said in a statement. .”

Discounts are available through two programs: Pharmaceutical Assistance for the Elderly and Disabled, or PAAD, and the Senior Gold Prescription Discount Program.

The expansion comes as the Build Back Better Act, a federal bill that includes a provision allowing Medicare to negotiate prices with drugmakers, stalled in Congress.

More on the invoice: NJ Democrats Approve Medicare Price Negotiations, But Will Biggest Bill Pass?

The Murphy administration said the state was taking steps to provide financial assistance. He included $25 million in his budget this fiscal year to reduce the cost of health insurance and prescription drugs.

As part of this plan, Murphy raised the income limit by $10,000 on the PAAD and Senior Gold programs. The expansion took effect Jan. 1 and could be available for 20,000 New Jersey residents.

PAAD is now open to residents 65 and older and people with disabilities earning up to $38,769 if single and $45,270 for couples. It cuts prices to $5 for covered generic drugs and $7 for covered name brands.

The Senior Gold Prescription Discount program is for seniors and people with disabilities earning up to $48,769 if single and $55,270 if married. It offers drugs at half price after a $15 copayment.

Medicare-eligible consumers must be enrolled in Medicare Part D, the prescription drug plan, to participate. To complete an application, go to https://www.state.nj.us/humanservices/doas/services/njsave/

The expansion of the program was unanimously approved last year by the Assembly and the Senate. And it won the endorsement of AARP New Jersey, a consumer group that found Americans pay three times more for prescription drugs than their counterparts in other countries.

“Residents of all ages depend on their prescriptions, and no one should have to choose between food, medicine, or rent,” Evelyn Liebman, AARP New Jersey’s advocacy director, said last year about Bill. “Prescription drugs don’t work if people can’t afford them. This extension will also expand eligibility for essential public service assistance programs for those who need them most.”

Michael L. Diamond is a business journalist who has written about New Jersey’s economy and the health care industry for more than 20 years. He can be contacted at [email protected]

This article originally appeared on Asbury Park Press: NJ PAAD: More Seniors Now Eligible to Buy Discounted Drugs

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Generic drugs

Oncohiv to Restore Confidence in Generic Drugs with Safe and Reliable Generic Options

India is also a country with one of the highest direct spending per capita

In a developing country like India, generic drugs play a vital role in supporting the public health system. Similar to brand names, these generic drugs also need FDA approval stating that the drug composition, dosage, and kinetics are the same as brand name drugs. However, generic drugs are generally 30-80% cheaper than their brand-name equivalents, making them more cost effective for the general population. Oncohiv, a distributor of generic and over-the-counter drugs, offers on its online platform some of the best generic drug options for a wide range of conditions.

India is home to a large portion of the poor population who cannot access modern health facilities due to its prohibitive cost. India is also a country with one of the highest direct spending per capita. Thus, generic drugs can significantly reduce the costs of medical services and make public health care more affordable. At the same time, it is also proven that generic drugs are no different from their branded counterparts in terms of dosage, route of administration, strength, quality, kinetics and intended use. Given its merit to the public health system, the Indian government has taken several regulatory steps to popularize the use of generics in India. In 2008, the Indian government, through the Department of Pharmaceuticals, launched a new “Jan Aushadhi” initiative as part of this effort. The Medical Council of India has recommended that every doctor prescribe drugs with legible generic names and that he or she ensure that there is a rational prescription that promotes the use of generic drugs. Oncohiv’s online generic medicine platform aligns with the same vision of affordable and accessible healthcare in India.

Oncohiv offers a wide variety of cancer drugs that treat a myriad of cancers and health risks, including blood cancer, brain cancer, breast cancer, liver cancer, leukemia, low platelet count, l hepatic encephalopathy, prostate cancer, skin cancer, psoriasis and thyroid cancer. They are also certified distributors of drugs used in the treatment of diseases such as hepatitis B, hepatitis C, Hodgkin’s disease and HIV / AIDS. Following the latest coronavirus outbreak, they listed generic ivermectin drugs used in the treatment of Covid19 like Iverheal 12, Iverheal 3, Iverheal 6, Iversun 12mg and Iverwon 12mg among many others to help people to easily obtain these emergency drugs. Ivermectin is a fast-acting drug that has been shown to be effective in curing several parasitic infections. In addition to treating the condition, the drug also lowers the risk of developing deadly foods.

Oncohiv also offers life-saving medicines like Flacigo, hydroxychloroquine and doxycycline, as well as other antibiotic medicines.

Oncohiv is a generics market that prioritizes compliance with strict regulatory measures to match international standards. A quality audit team works regularly to monitor all drugs and orders to ensure the best services and experiences for all their consumers. They carefully follow guidelines to ensure customer safety and privacy. Indeed, the products and brands offered by Oncohiv are manufactured in facilities approved by the World Health Organization (WHO) attesting to the safety of their drugs. In the post-pandemic world, when the government tries to rebuild its medical infrastructure, Oncohiv plans to help the government’s efforts with its generic and OTC products.

End of

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Generic drugs

Oncohiv will restore trust in generic drugs with safe and reliable generic options

In a developing country like India, generic drugs play a vital role in supporting the public healthcare system. Similar to brand names, these generic drugs also need to get FDA approval stating that the composition, administration dosage, and kinetics of the drug are the same as the brand name drugs. However, generic drugs are typically 30-80% less expensive than their originator equivalents, making them more cost-effective for the general population. Oncohiv, a generic and over-the-counter drug distributor, offers some of the industry’s best generic drug options for a wide range of conditions on its online platform.

India is home to a large portion of the poor population who lack access to modern healthcare facilities due to their prohibitive cost. India is also a country with one of the highest personal expenditure per capita. Thus, generic drugs can significantly reduce the costs of medical services and make public health care more affordable. At the same time, generic drugs are also proven to be no different from their branded counterparts in terms of dosage, route of administration, strength, quality, kinetics, and intended use. Considering its interest in the public healthcare system, the Indian government has taken several regulatory measures to popularize the use of generics in India. In 2008, the Government of India, through the Department of Pharmaceuticals, launched a new “Jan Aushadhi” initiative as part of this effort. The Medical Council of India has recommended that every doctor should prescribe drugs legibly with generic names and ensure that there is rational prescribing which promotes the use of generic drugs. Oncohiv’s online generic drug platform aligns with the same vision of affordable and accessible healthcare in India.

Oncohiv offers a wide variety of cancer drugs treating a myriad of cancers and associated health risks, including blood cancer, brain cancer, breast cancer, liver cancer, leukemia, low platelet count, hepatic encephalopathy, prostate cancer, skin cancer, psoriasis and thyroid cancer. They are also certified distributors of drugs used in the treatment of diseases such as hepatitis B, hepatitis C, Hodgkin’s disease and HIV/AIDS. Following the latest coronavirus outbreak they have listed generic ivermectin drugs used in Covid19 treatment as Iverheal 12, Iverheal 3, Iverheal 6, Iversun 12mg and Iverwon 12mg among many others to help people easy access to these emergency drugs. Ivermectin is a fast-acting drug that has been proven to effectively cure several parasitic infections. In addition to treating the disease, the drug also reduces the risk of developing deadly foods.

Oncohiv also sells lifesaving drugs like Flacigo, Hydroxychloroquine and Doxycycline along with other antibiotic drugs.

Oncohiv is a generic marketplace that prioritizes compliance with strict regulatory measures to match international standards. A quality audit team works regularly to monitor all medications and orders to ensure the best services and experiences for all of their consumers. They carefully follow guidelines to ensure customer safety and privacy. Indeed, the products and brands offered by Oncohiv are manufactured in facilities approved by the World Health Organization (WHO) attesting to the safety of their medicines. In the post-pandemic world, as the government attempts to rebuild its medical infrastructure, Oncohiv plans to aid the government’s efforts with its generic and over-the-counter products.

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Generic drugs

Some branded paracetamol out of stock; the government calls for the use of generic drugs

Metro Manila (CNN Philippines, January 4) — A pharmaceutical company confirmed on Tuesday that some branded paracetamols are temporarily unavailable due to increased demand amid rising COVID-19 cases in the country.

Unilab, a leading maker of flu and cold medicines, said there was a shortage of pharmaceutical stocks carrying some of its popular brands, including Bioflu, Neozep and Solmux. The company said it was working double time to expedite their restocking as soon as possible.

“Some of our brands are temporarily out of stock at select pharmacies due to extraordinary demand,” he said in a statement.

Zuellig Pharma also acknowledged that there was a temporary shortage of certain brands of paracetamol in certain regions following heightened vigilance against the Omicron variant. Also, a number of people get sick for a variety of reasons, including colder weather.

“We urge the public to consult their doctors and pharmacists for suitable alternatives if they experience a temporary shortage of paracetamol in their localities. have a limited shelf life or expiration date, and to consider other patients who may need it more,” said Jannette Jakosalem, CEO of Zuellig Pharma, in a statement.

CNN Philippines was greeted by long lines outside pharmacies in Barangka, Mandaluyong on Monday night after some netizens reported difficulty buying paracetamol.

The Department of Health (DOH) said Tuesday it has contacted major pharmacies and local manufacturers after seeing increased demand for over-the-counter drugs used to treat fever and flu, which are some of the common symptoms of the COVID-19.

Speaking to CNN Philippines, Generika President and CEO Josette Abarca shared the same experience at their branches, saying the demand for branded flu drugs was five times higher than normal.

The Department of Trade and Industry (DTI) also noted a “tight supply” for some brands, but stressed that this is only due to the timing of deliveries to replenish stocks in parapharmacies.

The agency also said it was in contact with drugstores and pharmacies to limit the purchase quantity to prevent panic buying.

The DOH and DTI pointed out that there was only a shortage of brand name paracetamols and urged the public to consider buying generic drugs.

“Paracetamol has many generic alternatives on the market, which are available at many pharmacies nationwide,” the DOH said.

“There are other brands of paracetamol on the market, so there is no shortage,” added the DTI.

Abarca assured the public that he had an adequate supply of generic drugs, saying that these had the same effectiveness as branded drugs.

Pharmacist Arshie Larga, who works at his family pharmacy in Marinduque, said he lacked specific brands of paracetamol but had sufficient stock of generics. He reminded the public that generic drugs are a good alternative in the face of supply problems.

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Generic drugs

Generic Drugs Market in United States, By Type, By Application, By Drug Delivery Method, By Form, By Source, By Distribution Channel, By Region, Competition, Forecast And Opportunity, 2026

Generic Drugs Market in United States, By Type (Small Molecule Generics Vs Biosimilars), By Application (Cardiovascular Diseases, Diabetes, Neurology, Oncology, Infectious Diseases, Others), By Mode Of Drug Administration (Oral, Topical, parenteral, other), by form (tablet, capsule, injection, other), by source (in-house or contract manufacturing organizations), by distribution channel (hospital pharmacies, retail pharmacies, online pharmacies, others), by region, competition, forecast and opportunities, 2026

New York, December 23, 2021 (GLOBE NEWSWIRE) – Reportlinker.com announces the publication of the report “Generic Drugs Market in United States, By Type, By Application, By Drug Administration, By Form, By Source, by distribution Channel, by region, competition, forecast and opportunities, 2026 “- https://www.reportlinker.com/p06192577/?utm_source=GNW

The US generic drug market was valued at USD 70.78 billion in 2020 and is expected to grow at a CAGR of 9.43% during the forecast period and may reach a market value of USD 126.74 billion by 2026. Factors such as the profitable nature of generic drugs and increasing demand from developing economies are primarily responsible for this estimate of the futuristic growth of the US generic drug market over the next five years. Generic drugs do not require extensive research and development like prescription drugs and patented drugs. Market players and research institutes invest heavily in pharmaceutical patents. In addition, FDA approvals for generic drugs are not required because the generic drugs contain the same composition as the previously patented drug and thus support the growth of the US generic drug market over the next five years. The healthcare industry in the United States, in terms of generic drugs, has gone from an 80% growth in 2020 to a previous growth of 20% in 2015.
Increasing exports of generic drugs to developing economies like Kenya, India etc. also confirms the growth of the US generic drug market in the next five years.
The generic drugs market in the United States is segmented on the basis of drug type, mode of administration, form, source of manufacture, application, company, and regional distribution. Based on type, the market can be divided into generics and small molecule biosimilars.

Small Molecule Generics are expected to achieve the largest market revenue shares and dominate the market segment over the next five years due to their simpler and easier manufacturing processes. Manufacturers of generic drugs when producing generics with small molecules are required to prove that the end product contains chemical compounds identical to those of the patented drug.

With similar pharmacokinetic functions and properties, the generic small molecule is accepted. In addition, the demand for cost-effective generic drugs is expected to further support the growth of the US generic drug market over the next five years.
Based on the applications, the market may be fragmented into cardiovascular disease, diabetes, neurology, oncology, infectious disease, and others. Cardiovascular disease is expected to dominate the market segment while recording the largest market revenue shares over the next five years on account of growing cardiovascular disease cases in the United States.

Additionally, the increased demand for the treatment and extended drug regimens is driving the growth of the cardiovascular disease sub-segment while supporting the growth of the generic drug market in the United States over the next five years. Increased pharmaceutical research and development for the oncologic disease is expected to drive the growth of the oncology sub-segment and drive the growth of the US generic drug market over the next five years.
Teva Pharmaceuticals USA, Inc., Pfizer Inc., Sandoz US, Endo Pharmaceuticals Inc., Aurobindo Pharma USA, Inc., Abbott Laboratories Inc., Eli Lilly and Company, Sun Pharma Inc., Lupine Pharmaceuticals, Inc. and Zydus Pharmaceutical USA Inc. is among the major market players in United States leading the growth of the generic drug market.

Years considered for this report:

Historical years: 2016-2019
Baseline year: 2020
Estimated year: 2021
Forecast period: 2022-2026

Goal of the study:

• To analyze the historical growth in the market size of the generic drugs market in the United States from 2016 to 2020.
• Estimate and forecast the US generic drugs market size from 2021 to 2026 and the growth rate to 2026.
• To categorize and forecast the United States generic drug market on the basis of drug type, application, drug administration route, form, source, distribution channel, competitive landscape, and regional distribution.
• Identify the dominant region or segment in the generic drug market in the United States.
• Identify the drivers and challenges of the US generic drug market.
• Examine competitive developments such as expansions, new product launches, mergers and acquisitions, etc., in the US generic drug market.
• Identify and analyze the profile of the main players operating in the US generic drug market.
• Identify the main sustainable strategies adopted by the players in the generic drugs market in the United States.
The analyst performed both primary and secondary research exhaustive for this study. Initially, the analyst found a list of manufacturers around the world.

Subsequently, the analyst conducted primary research surveys of the identified companies. During the interviews, respondents were also asked about their competitors.

Using this technique, the analyst could include manufacturers who could not be identified due to the limitations of secondary research. The analyst looked at manufacturers, distribution channels and the presence of all major players across the globe.
The analyst calculated the size of the generic drugs market in the United States using a bottom-up approach, in which data from various end-user segments was recorded and forecast for years to come. The analyst obtained these values ​​from industry experts and company representatives and validated them externally by analyzing historical data for these types of products and applications to arrive at an appropriate overall market size.

Various secondary sources such as company websites, news articles, press releases, company annual reports, investor presentations, and financial reports were also investigated by the analyst.

Key target audience:

• Manufacturers, suppliers, distributors and other stakeholders of generic drugs
• Government bodies such as regulatory authorities and policy makers
• Organizations, forums and alliances related to generic drugs
Market research and consulting firms
The study is useful in providing answers to several critical questions that are important to industry players such as manufacturers, suppliers, partners, end users, etc., in addition to enabling them to develop investment strategies and capitalize on market opportunities.

Scope of the report:

In this report, the United States Generic Drugs Market has been segmented into the following categories in addition to industry trends which have also been detailed below:
• Generic Drugs Market in United States, by Type:
o Generic Small Molecule
o Biosimilars
• United States Generic Drugs Market, By Application:
o Cardiovascular diseases
o Diabetes
o Neurology
o Oncology
o Infectious diseases
o Others
• Generic drug market in the United States, by drug administration method:
o Oral
o Parenteral
o Topical
o Others
• Generic Drugs Market in United States, by Form:
Tablet
o Capsule
o Injection
o Others
• Generic drugs in the United States, by source:
o In-house manufacturing
o Contract manufacturing organizations
• Generic drug market in the United States, by distribution channel:
o Retail pharmacies
o Online pharmacies
o Hospital pharmacies
o Others
• Generic drug market in United States, by region:
o South
o Midwest
o West
o North East

Competitive landscape

Company Profiles: Detailed analysis of the major companies present in the global generic drugs market.

Customizations available:

With the market data provided, we offer customizations based on the specific needs of a business. The following customization options are available for the report:

Company Info

• Detailed analysis and profiling of additional market players (up to five).
Read the full report: https://www.reportlinker.com/p06192577/?utm_source=GNW

About Reportlinker
ReportLinker is an award winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.

__________________________

CONTACT: Clare: [email protected] US: (339)-368-6001 Intl: +1 339-368-6001
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Generic drugs

Generic Inhalation and Nasal Spray Market $ 6.87 Billion by Indication, Age Group, Class, Route, Distribution Channel and Region

Dublin, December 23, 2021 (GLOBE NEWSWIRE) – The ‘Generic Inhalation Drugs and Nasal Sprays Market Research Report by Indication, Age Group, Class, Route, Distribution Channel and Region – Global Forecast to 2026 – Cumulative impact of COVID- Report 19 “has been added to ResearchAndMarkets.com offer.

The global generic inhalation and nasal spray market size was estimated to be USD 6,392.52 million in 2020, is expected to reach USD 6,879.55 million in 2021, and is expected to grow at a CAGR of 7.95% to reach 10,119 , 95 million USD by 2026.

Market statistics
The report provides market size and forecast in five major currencies: USD, EUR GBP, JPY, and AUD. It helps organizational leaders make better decisions when currency data is readily available. In this report, the years 2018 and 2019 are considered as historical years, 2020 as the base year, 2021 as the estimated year and the years 2022 to 2026 are considered as the forecast period.

Market segmentation and coverage

This research report categorizes Generic Inhalation Drugs and Nasal Sprays to forecast revenue and analyze trends in each of the following submarkets:

  • Based on the indication, the market has been investigated for allergic rhinitis, asthma and COPD.

  • Based on age group, the market has been researched among adults, children 2-5 years old, and children 6-12 years old.

  • Based on the class, the market has been studied for allergy blockers, anticholinergics, antihistamines, decongestants, mast cell inhibitors, and nasal steroids.

  • Based on Route, the market has been investigated for inhalation, nasal spray, and tropical lotion.

  • Based on the distribution channel, the market has been studied in hospital medical stores, online pharmacies and retail pharmacies.

  • Based on the region, the market has been studied in the Americas, Asia-Pacific and Europe, Middle East and Africa. The Americas are studied in more detail in Argentina, Brazil, Canada, Mexico and the United States. The United States is studied in more detail in California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. Asia-Pacific is further explored in Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand. Europe, the Middle East and Africa are studied in more detail in France, Germany, Italy, the Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates and United Kingdom.

Companies mentioned

  • Allergan plc

  • Altaire Pharmaceuticals inc.

  • Beximco Pharmaceuticals Ltd.

  • Catalent Pharma Solutions

  • Cipla Limited

  • Hikma Pharmaceuticals PLC

  • Mylan NV

  • Navajo Manufacturing Company Inc.

  • Pharmaceutical company Nephron

  • Perrigo Company plc

  • Preferred Pharmaceuticals Inc.

  • Sandoz International GmbH

  • Sheffield Pharmaceuticals LLC

  • Sun Pharmaceutical Industries Ltd.

  • Teva Pharmaceutical Industries Ltd.

Cumulative impact of COVID-19
COVID-19 is an incomparable global public health emergency that has affected nearly all industries, and the long-term effects are expected to impact the growth of the industry during the forecast period. The analyst’s ongoing research is amplifying their research framework to ensure the inclusion of the underlying issues of COVID-19 and potential avenues to follow. The report provides insights on COVID-19 given changes in consumer behavior and demand, purchasing patterns, supply chain diversion, dynamics of current market forces, and significant government interventions. . The updated study provides information, analysis, estimates and forecasts, considering the impact of COVID-19 on the market.

Competitive strategic window
The Competitive Strategy Window analyzes the competitive landscape in terms of markets, applications and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for suppliers to adopt successive strategies of merger and acquisition, geographic expansion, research and development, and new product introduction strategies to continue the expansion and growth of the business during a forecast period.

FPNV positioning matrix
The FPNV Positioning Matrix assesses and ranks vendors in the Generic Inhalation and Nasal Spray market based on business strategy (company growth, industry coverage, financial viability, and channel support) and product satisfaction (value for money, ease of use, product features) and customer support) which helps businesses make better decisions and better understand the competitive landscape.

Market share analysis
The market share analysis offers the analysis of the suppliers considering their contribution to the overall market. It provides the idea of ​​its revenue generation in the overall market compared to other space providers. It provides insight into the performance of vendors in terms of revenue generation and customer base compared to others. Knowing the market share gives an idea of ​​the size and competitiveness of the suppliers for the base year. It reveals the characteristics of the market in terms of traits of accumulation, fragmentation, dominance and fusion.

Competitive scenario
The competitive scenario provides a outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section delivers valuable insights at different stages while staying up to date with the business and engaging stakeholders in the economic debate. The competitive scenario represents press releases or news from companies categorized as M&A, Agreement, Collaboration and Partnership, New Product Launch and Improvement, Investment and Funding, and Reward, Recognition and Expansion. All the news gathered helps the supplier understand the market gaps and the strengths and weaknesses of competitors, thus providing information to improve products and services.

Main topics covered:

1. Preface
1.1. Objectives of the study
1.2. Market segmentation and coverage
1.3. Years taken into account for the study
1.4. Currency and price
1.5. Language
1.6. Limits
1.7. Hypotheses
1.8. Stakeholders

2. Research methodology

3. Executive summary

4. Market overview
4.1. introduction
4.2. Cumulative impact of COVID-19

5. Market dynamics
5.1. introduction
5.2. Conductors
5.2.1. Low cost associated with generic prescription drugs
5.2.2. Increased prevalence of asthma and COPD disorders
5.2.3. High cost of health care in developed regions
5.3. Constraints
5.3.1. Strict regulations for generic drugs
5.4. Opportunities
5.4.1. Successful drug patents expire and FDA approvals increased
5.4.2. Trend towards generic drugs in developed countries due to rising cost of health care
5.5. Challenges
5.5.1. Pressure on prices due to the presence of several players in the segment

6. Generic Inhalation and Nasal Sprays Market, by Indication
6.1. introduction
6.2. Allergic rhinitis
6.3. Asthma
6.4. COPD

7. Generic Inhalation Nasal Spray Drugs Market, By Age Group
7.1. introduction
7.2. Adults
7.3. Children 2 to 5
7.4. Children 6 to 12

8. Generic Inhalation and Nasal Spray Drugs Market, By Class
8.1. introduction
8.2. Allergy blocker
8.3. Anticholinergic
8.4. Antihistamine
8.5. decongestant
8.6. Mast cell inhibitor
8.7. Nasal steroid

9. Generic inhalation and nasal sprays market, by road
9.1. introduction
9.2. Inhalation
9.3. Nasal spray
9.4. Tropical Lotion

10. Generic inhalation and nasal sprays market, by distribution channel
10.1. introduction
10.2. Hospital medical store
10.3. Online pharmacy
10.4. Retail pharmacy

11. America Generic Inhalation and Nasal Spray Market

12. Asia-Pacific Generic Inhalation and Nasal Spray Market

13. Europe, Middle East & Africa Generic Inhalation Drugs and Nasal Sprays Market

14. Competitive landscape
14.1. FPNV positioning matrix
14.1.1. Quadrants
14.1.2. Business strategy
14.1.3. Product satisfaction
14.2. Market ranking analysis
14.3. Market share analysis, by key player
14.4. Competitive scenario
14.4.1. Merger & Acquisition
14.4.2. Agreement, collaboration and partnership
14.4.3. New product launch and improvement
14.4.4. Investment and financing
14.4.5. Awards, recognition and expansion

15. Company usability profiles

For more information on this report visit https://www.researchandmarkets.com/r/374c1l

CONTACT: CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
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Generic drugs

U.S. Generic Drugs Market, By Type, By

New York, 23 Dec. 2021 (GLOBE NEWSWIRE) — Reportlinker.com Announces Release of United States Generic Drugs Market, By Type, By Application, By Mode of Drug Delivery, By Form, By Source, By Distribution Channel, By Region, Competition, Forecast and Opportunities, 2026″ – https://www.reportlinker.com/p06192577/?utm_source=GNW

The generic drugs market in the United States was valued at USD 70.78 billion in 2020 and is expected to grow at a CAGR of 9.43% during the forecast period and may reach a market value of USD 126.74 billion. ‘by 2026. Factors such as the cost-effective nature of generic drugs and growing demand from developing economies are largely responsible for this futuristic growth estimate of the US generic drugs market over the next five years. Generic drugs do not require extensive research and development like prescription drugs and brand name drugs. Market players and research institutes are investing heavily in patented pharmaceuticals. Moreover, FDA approvals for generic drugs are not required since generic drugs contain the same composition as that of the previously patented drug and thus support the growth of the generic drug market in the United States over the next five years. . The healthcare industry in the United States, in terms of generic drugs, has gone from 80% growth in 2020 to a previous growth of 20% in 2015.
The increase in generic drug exports to developing economies like Kenya, India, etc. also justifies the growth of the US generic drug market in the next five years.
The US generic drugs market is segmented on the basis of type, drug delivery route, form, manufacturing source, application, company, and regional distribution. Based on type, the market can be divided into generics and small molecule biosimilars.

Small molecule generics are expected to register the largest market revenue shares and dominate the market segment over the next five years owing to its simpler and easier manufacturing processes. Generic drug manufacturers when producing small molecule generics are required to prove that the final product contains the same chemical compounds as the patented drug.

With similar functions and pharmacokinetic properties, the generic small molecule is accepted. Additionally, the demand for cost-effective generic drugs is expected to further support the growth of the generic drugs market in the United States over the next five years.
Based on the applications, the market can be fragmented into cardiovascular diseases, diabetes, neurology, oncology, infectious diseases and others. Cardiovascular diseases are expected to dominate the market segment while recording the highest market revenue shares over the next five years on account of the increasing cases of cardiovascular diseases in the United States.

Additionally, increased demand for treatment and extended medication protocols is driving the growth of cardiovascular disease sub-segment while sustaining the growth of the generic drug market in the United States over the next five years. Rising pharmaceutical research and development for the oncology disease is expected to drive the growth of the oncology sub-segment and drive the growth of the US generic drug market over the next five years.
Teva Pharmaceuticals USA, Inc., Pfizer Inc., Sandoz US, Endo Pharmaceuticals Inc., Aurobindo Pharma USA, Inc., Abbott Laboratories Inc., Eli Lilly and Company, Sun Pharma Inc., Lupine Pharmaceuticals, Inc. and Zydus Pharmaceutical USA Inc. is among the major market players in the United States leading the growth of the generic drugs market.

Years considered for this report:

Historical years: 2016-2019
Reference year: 2020
Estimated year: 2021
Forecast period: 2022-2026

Goal of the study:

• To analyze the historical growth of the market size of the generic drugs market in the United States from 2016 to 2020.
• Estimate and forecast the market size of Generic Drugs Market in United States from 2021 to 2026 and the growth rate till 2026.
• To classify and forecast the U.S. Generic Drugs Market based on type, application, mode of drug delivery, form, source, distribution channel, competitive landscape, and regional distribution .
• Identify the dominant region or segment in the generic drug market in the United States.
• To identify drivers and challenges for the generic drug market in the United States.
• Examine competitive developments such as expansions, new product launches, mergers and acquisitions, etc., in the generic drug market in the United States.
• Identify and analyze the profile of the main players operating in the generic drugs market in the United States.
• Identify the key sustainable strategies adopted by market players in the generic drugs market in the United States.
The analyst conducted extensive primary and secondary research for this study. Initially, the analyst procured a list of manufacturers across the world.

Subsequently, the analyst conducted primary research surveys with the identified companies. During the interviews, the respondents were also asked about their competitors.

Using this technique, the analyst could include manufacturers that could not be identified due to secondary research limitations. The analyst looked at the manufacturers, distribution channels and presence of all major players across the globe.
The analyst calculated the size of the generic drugs market in the United States using a bottom-up approach, in which data from various end-user segments was recorded and forecasted for the coming years. The analyst obtained these values ​​from industry experts and company representatives and validated them externally by analyzing historical data of these types of products and applications to derive an appropriate overall market size.

Various secondary sources such as company websites, news articles, press releases, company annual reports, investor presentations and financial reports were also studied by the analyst.

Key target audience:

• Manufacturers, suppliers, distributors and other stakeholders of generic medicines
• Government bodies such as regulators and policy makers
• Organizations, forums and alliances related to generic medicines
• Market research and consulting firms
The study is helpful in providing answers to several critical questions which are important for industry stakeholders such as manufacturers, suppliers, partners, end users etc. besides enabling them to elaborate investment strategies and to capitalize on market opportunities.

Report Scope:

In this report, the generic drugs market in the United States has been segmented into the following categories, in addition to industry trends which have also been detailed below:
• Generic drugs market in the United States, by type:
o Generic Small Molecule
o Biosimilars
• Generic drugs market in the United States, by application:
o Cardiovascular diseases
o Diabetes
o Neurology
o Oncology
o Infectious diseases
o Others
• Generic drug market in the United States, by mode of drug administration:
o Oral
o Parenteral
o Topical
o Others
• Generic drugs market in the United States, by form:
o Tablet
o Capsule
o Injection
o Others
• Generic drugs in the United States, by source:
o In-house manufacturing
o Contract manufacturing organizations
• Generic drugs market in the United States, by distribution channel:
o Retail pharmacies
o Online pharmacies
o Hospital pharmacies
o Others
• Generic drugs market in the United States, by region:
o South
o Midwest
o West
o Northeast

Competitive landscape

Company Profiles: Detailed analysis of the major companies present in the global generic drugs market.

Customizations available:

With the market data provided, we offer customizations based on a company’s specific needs. The following customization options are available for the report:

Company information

• Detailed analysis and profiling of other market players (up to five).
Read the full report: https://www.reportlinker.com/p06192577/?utm_source=GNW

About Reportlinker
ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.

__________________________


        
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Generic drugs

PODIUM | Bennet helps exempt generic drugs through BBB | Opinion






Maya wheeler


“About 18 million Americans, or 7% of American adults, say they recently couldn’t afford at least one prescription drug for their household, according to a new poll from Gallup and West Health.”

Democrats, Republicans and Independents grapple with even insured health care costs as prescription drug prices continue to rise. No one should be forced to choose between filling their prescriptions or their rent, gas, heat or food.

However, what is not clear is whether our elected officials choose between the people they represent and the Big Pharma lobbyists who write checks to their campaigns.

President Biden’s Build Back Better Act includes provisions that could go a long way toward implementing these long-promised drug reform policies. The new $ 35 cap on out-of-pocket expenses for insulin for patients on commercial or health insurance plans is a big step forward for vulnerable patients.

High drug prices disproportionately impact the sickest and poorest Americans. Nearly one in 10 Americans with three or more chronic conditions said they had to skip a drug purchase in the past three months, compared to about one in 25 people without any chronic illness, according to a Gallup poll. Skipping the purchase or rationing of drugs can be fatal. This was illustrated by NPR with the story of Nicole Smith-Holt, who lost her son three days before his next payday because he couldn’t afford to fill his insulin prescription. The price of insulin, which has no generic equivalent, has more than doubled since 2012. Those most in need of prescription drugs are also most likely to be negatively impacted by lack of access affordable drugs.

For minority communities, access to affordable insulin is an even bigger problem. Almost one in five black adults has diabetes, a rate more than double the white patient population. The high cost of care also contributes to a higher death rate. Black Americans die twice as fast as their counterparts from diabetes.

We have already seen the ugly health disparities in our system at the forefront of the COVID-19 pandemic, as patients of color have died at much higher rates than whites. Capping out-of-pocket spending will immediately benefit all patients, and especially those in the minority community who need help the most.

However, the Build Back Better Act is not perfect and some provisions could actually make drugs more expensive and less accessible. The inflation price rebate penalty looks good – drug makers should not be allowed to increase their prices more than the rate of inflation. But it really only works for brand name drugs, which have a government-protected monopoly. This allows companies making the most expensive drugs to set their prices as high as they want.

Generic drug makers, on the other hand, face much larger price fluctuations and a more competitive market, resulting in lower costs for consumers. And generic drug prices continue to decline on average year over year. The prices of brand-name drugs, meanwhile, continue to be “unsustainable, unjustifiable and unfair,” according to a recent report by Democrats in Congress. So it does not make sense to penalize a generic drug costing $ 1 for raising its price to $ 1.04, but to give a free pass to a large pharmaceutical company raising the price of its brand name drug by 10,000. $ to $ 10,299. As written, this is what the in-house version of the Build Back Better Act would do.

Fortunately, Senator Michael Bennet and his colleagues on the Senate Finance Committee took note and exempted generic drugs from the penalty. It is the right decision, politically and, more importantly, morally.

Generics and biosimilars account for 90% of prescriptions filled in the United States, but brand name drugs represent 80% of spending. For example, the osteoporosis drug Fosamax cost $ 2.60 per day or $ 80 per month. Now its generic version costs $ 0.28 per day, less than $ 9 per month.

These savings and the availability of cheaper drugs could be jeopardized by these new federal government policies if they are not changed. Low-income and working-class families, as well as seniors living on fixed incomes, would be at risk.

Senator Bennet has repeatedly shown his willingness to learn complex policies, understand its long-term impacts and make the necessary changes. The White House Biden should again heed his leadership and support the Senate version of the Build Back Better Act that makes the bill more patient-friendly.

Elected officials have been promising drug prices to drop for a long, long time. To come so close, and then fall victim to unintended political consequences thanks to the powerful lobbying of Big Pharma, would be a grave mistake.

Maya Wheeler is Executive Director of the African Chamber of Commerce, Colorado, and former Chair of the Colorado African American Democrats Initiative (AAICD) with the CO Democratic Party.

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Generic drugs

Studies Proving Generic Drugs Can Fight COVID Dropped

The emergence of Omicron in the United States and the announcement of the first reported death in the United Kingdom reminds us of how little we understand about the new coronavirus, and with less effective vaccines against the new variant, how much we have need additional resources to combat it. To expand our knowledge about COVID-19 and identify the best ways to treat and prevent it, physicians should be able to use all the safe means available to them to help patients. Unfortunately, this is not possible in our current political climate.

Since the summer of 2020, US public health agencies have continuously shut down the use or even discussion of unprofitable generic treatments. The National Institutes of Health (NIH) funded 20 large pharmaceutical industry patented drug research studies before only recently (and slowly) agreed to study reused generic drugs.

The Food and Drug Administration and the Centers for Disease Control have not recommended any recommendations. Instead, the Biden administration threw its political clout almost solely behind mass vaccinations, and hospitals and pharmacies dogmatically followed suit. But this approach is not enough to stop COVID-19.

Reused Generic Drugs That Help Fight COVID

Just look at the evidence on fluvoxamine, a widely used generic antidepressant. A randomized controlled trial (RCT) published in November 2020 showed that the drug caused much less clinical deterioration in treated patients. Another larger, double-blind RCT, published in The Lancet in October this year, found that fluvoxamine reduced COVID-19-related death rates by up to 91% and hospitalizations by two-thirds. This is an FDA approved drug. Dosed correctly and for such short periods of time, it is safe. And it costs about a dollar a pill.

These findings have since been further reinforced by another study published by the Journal of the American Medical Association in November, which showed a strong “class effect” of the benefits of antidepressants very similar to fluvoxamine against COVID-19. Yet despite the large, double-blind, placebo-controlled trial, neither the NIH nor the Infectious Diseases Society of America (IDSA) have come up with a recommendation for the routine use of these drugs to treat COVID-19.

The NIH to date has ignored the study. His last update on fluvoxamine was in April, over seven months ago. More troubling is the fact that the IDSA recently reviewed this high-quality trial, while staying true to its recommendation “not to use outside of a clinical trial”. Why do reused drugs require multiple trials before an agency’s recommendation, while new, high-profit, patented drugs are routinely approved after just one trial?

A recent and more cheeky example is Merck’s expensive new COVID-19 antiviral drug, molnupiravir. The FDA quickly approved it based on a single study of modest benefit in mildly ill outpatients, and the Biden administration quickly agreed to pay $ 700 per treatment. This was all despite the fact that the drug costs around $ 20 per course to manufacture, according to a consultant to the World Health Organization, and may prove to be less effective or even harmful in practice.

With our national debt standing at $ 2.77 trillion and skyrocketing inflation, strengthening our federal government’s capacity to study inexpensive generic drugs would be a smart economic move. But it seems there is no appetite for fiscal prudence or scientific research beyond the expensive and newly created solutions by our country’s pharmaceutical industry.

Hospital bans proven treatment

Doctors who don’t respect the line are subject to censorship and threatened with losing their livelihood, regardless of their clinical experience. My colleague Dr Paul Marik, a medical scientist practicing in Norfolk, Virginia, is one of them. He has treated patients throughout the COVID epidemic and was one of the early advocates of the use of steroids to treat COVID patients – a practice initially discouraged by federal health officials who turned since proven effective.

When evidence first emerged about fluvoxamine, we began to study the drug and share clinical data with doctors from the Frontline COVID-19 Critical Care Alliance (FLCCC), a group of doctors for the purpose non-profit that we run together. We added it to our FLCCC protocol seven months ago. Marik began treating his patients with the drug in addition to steroids and a number of reused generic drugs, which helped halve the number of deaths in his hospital.

This progress is now at risk: Marik’s employer Sentara Norfolk General Hospital has banned the use of fluvoxamine along with several other generic drugs approved by the FDA to treat COVID-19 – and death rates are already increasing.

What is the hospital’s rationale for denying patients treatment that has proven to be effective in clinical trials? It sounds a lot like the NIH website and sounds just as hollow: “A lot [of these medicines] have not published peer reviewed, RCT [randomized controlled trial] available to assess both the efficacy and safety of COVID-19. “

Over the past two years, our political and public health authorities have spoken often of trusting science to guide an effective response to this terrible virus, but their actions have more often been dictated by tribalism and greed.

We will surely face new variants of COVID-19 after Omicron and other infectious disease outbreaks in the future. We can prepare by strengthening our government’s ability to study cost-effective treatments quickly and efficiently, and by empowering physicians to pursue all possible treatments that can help patients.

Pierre Kory, MD, is President and Chief Medical Officer of the Front-Line COVID-19 Critical Care Alliance.

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Generic drugs

Global Generic Inhalation and Nasal Spray Market Expected to Reach Over $ 10 Billion by 2026 – ResearchAndMarkets.com

DUBLIN – (COMMERCIAL THREAD) – The report “Generic Inhalation Drugs and Nasal Sprays Market Research Report by Indication, Age Group, Class, Route, Distribution Channel and Region – Global Forecast to 2026 – Cumulative Impact of COVID -19 “has been added to ResearchAndMarkets.com offer.

The global generic inhalation and nasal spray market size was estimated to be USD 6,392.52 million in 2020, is expected to reach USD 6,879.55 million in 2021, and is expected to grow at a CAGR of 7.95% to reach 10,119 , 95 million USD by 2026.

Market statistics

The report provides market size and forecast in five major currencies: USD, EUR GBP, JPY, and AUD. It helps organizational leaders make better decisions when currency data is readily available. In this report, the years 2018 and 2019 are considered as historical years, 2020 as the base year, 2021 as the estimated year and the years 2022 to 2026 are considered as the forecast period.

Market segmentation and coverage

This research report categorizes Generic Inhalation Drugs and Nasal Sprays to forecast revenue and analyze trends in each of the following submarkets:

  • Based on the indication, the market has been investigated for allergic rhinitis, asthma and COPD.

  • Based on age group, the market has been researched among adults, children 2-5 years old, and children 6-12 years old.

  • Based on the class, the market has been studied for allergy blockers, anticholinergics, antihistamines, decongestants, mast cell inhibitors, and nasal steroids.

  • Based on Route, the market has been investigated for inhalation, nasal spray, and tropical lotion.

  • Based on the distribution channel, the market has been studied in hospital medical stores, online pharmacies and retail pharmacies.

  • Based on the region, the market has been studied in the Americas, Asia-Pacific and Europe, Middle East and Africa. The Americas are studied in more detail in Argentina, Brazil, Canada, Mexico and the United States. The United States is studied in more detail in California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. Asia-Pacific is further explored in Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand. Europe, the Middle East and Africa are studied in more detail in France, Germany, Italy, the Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates and United Kingdom.

Companies mentioned

  • Allergan plc

  • Altaire Pharmaceuticals inc.

  • Beximco Pharmaceuticals Ltd.

  • Catalent Pharma Solutions

  • Cipla Limited

  • Hikma Pharmaceuticals PLC

  • Mylan NV

  • Navajo Manufacturing Company Inc.

  • Pharmaceutical company Nephron

  • Perrigo Company plc

  • Preferred Pharmaceuticals Inc.

  • Sandoz International GmbH

  • Sheffield Pharmaceuticals LLC

  • Sun Pharmaceutical Industries Ltd.

  • Teva Pharmaceutical Industries Ltd.

Cumulative impact of COVID-19

COVID-19 is an incomparable global public health emergency that has affected nearly all industries, and the long-term effects are expected to impact the growth of the industry during the forecast period. The analyst’s ongoing research is amplifying their research framework to ensure the inclusion of the underlying issues of COVID-19 and potential avenues to follow. The report provides insight on COVID-19 given changes in consumer behavior and demand, purchasing patterns, supply chain diversion, dynamics of current market forces, and significant government interventions. . The updated study provides information, analysis, estimates and forecasts, considering the impact of COVID-19 on the market.

Competitive strategic window

The Competitive Strategy Window analyzes the competitive landscape in terms of markets, applications and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for suppliers to adopt successive strategies of merger and acquisition, geographic expansion, research and development, and new product introduction strategies to continue the expansion and growth of the business during a forecast period.

FPNV positioning matrix

The FPNV Positioning Matrix assesses and ranks vendors in the Generic Inhalation and Nasal Spray market based on business strategy (company growth, industry coverage, financial viability, and channel support) and product satisfaction (value for money, ease of use, product features) and customer support) which helps businesses make better decisions and better understand the competitive landscape.

Market share analysis

The market share analysis offers the analysis of the suppliers considering their contribution to the overall market. It provides the idea of ​​its revenue generation in the overall market compared to other space providers. It provides insight into the performance of vendors in terms of revenue generation and customer base compared to others. Knowing the market share gives an idea of ​​the size and competitiveness of the suppliers for the base year. It reveals the characteristics of the market in terms of traits of accumulation, fragmentation, dominance and fusion.

Competitive scenario

The competitive scenario provides a outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section delivers valuable insights at different stages while staying up to date with the business and engaging stakeholders in the economic debate. The competitive scenario represents press releases or news from companies categorized as M&A, Agreement, Collaboration and Partnership, New Product Launch and Improvement, Investment and Funding, and Reward, Recognition and Expansion. All the news gathered helps the supplier understand the market gaps and the strengths and weaknesses of the competitors, thus providing information to improve products and services.

Main topics covered:

1. Preface

1.1. Objectives of the study

1.2. Market segmentation and coverage

1.3. Years taken into account for the study

1.4. Currency and price

1.5. Language

1.6. Limits

1.7. Hypotheses

1.8. Stakeholders

2. Research methodology

3. Executive summary

4. Market overview

4.1. introduction

4.2. Cumulative impact of COVID-19

5. Market dynamics

5.1. introduction

5.2. Conductors

5.2.1. Low cost associated with generic prescription drugs

5.2.2. Increased prevalence of asthma and COPD disorders

5.2.3. High cost of health care in developed regions

5.3. Constraints

5.3.1. Strict regulations for generic drugs

5.4. Opportunities

5.4.1. Successful drug patents expire and FDA approvals increased

5.4.2. Trend towards generic drugs in developed countries due to rising cost of health care

5.5. Challenges

5.5.1. Pressure on prices due to the presence of several players in the segment

6. Generic Inhalation and Nasal Sprays Market, by Indication

6.1. introduction

6.2. Allergic rhinitis

6.3. Asthma

6.4. COPD

7. Generic Inhalation Nasal Spray Drugs Market, By Age Group

7.1. introduction

7.2. Adults

7.3. Children 2 to 5

7.4. Children 6 to 12

8. Generic Inhalation and Nasal Spray Drugs Market, By Class

8.1. introduction

8.2. Allergy blocker

8.3. Anticholinergic

8.4. Antihistamine

8.5. decongestant

8.6. Mast cell inhibitor

8.7. Nasal steroid

9. Generic inhalation and nasal sprays market, by road

9.1. introduction

9.2. Inhalation

9.3. Nasal spray

9.4. Tropical Lotion

10. Generic inhalation and nasal sprays market, by distribution channel

10.1. introduction

10.2. Hospital medical store

10.3. Online pharmacy

10.4. Retail pharmacy

11. America Generic Inhalation and Nasal Spray Market

12. Asia-Pacific Generic Inhalation and Nasal Spray Market

13. Europe, Middle East & Africa Generic Inhalation Drugs and Nasal Sprays Market

14. Competitive landscape

14.1. FPNV positioning matrix

14.1.1. Quadrants

14.1.2. Business strategy

14.1.3. Product satisfaction

14.2. Market ranking analysis

14.3. Market share analysis, by key player

14.4. Competitive scenario

14.4.1. Merger & Acquisition

14.4.2. Agreement, collaboration and partnership

14.4.3. New product launch and improvement

14.4.4. Investment and financing

14.4.5. Awards, recognition and expansion

15. Company usability profiles

For more information on this report, visit https://www.researchandmarkets.com/r/1lry5e

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Generic drugs

The global market for generic inhalants and nasal sprays is expected to reach over $10 billion by 2026

DUBLIN, December 16, 2021–(BUSINESS WIRE)–The report “Inhalation & Nasal Sprays Generic Drugs Market Research Report by Indication, Age Group, Class, Route, Distribution Channel, and Region – Global Forecast to 2026 – Cumulative Impact of COVID-19” has been added to from ResearchAndMarkets.com offer.

The global Generic Inhalation Drugs and Nasal Sprays Market size was estimated at USD 6,392.52 million in 2020, is projected to reach USD 6,879.55 million in 2021 and is projected to grow at a CAGR of 7.95% to reach 10 USD 119.95 million by 2026.

Market statistics

The report provides market size analysis and forecasts for five major currencies – USD, EUR GBP, JPY and AUD. It helps organizational leaders make better decisions when currency data is readily available. In this report, the years 2018 and 2019 are considered as historical years, 2020 as the base year, 2021 as the estimated year and the years from 2022 to 2026 as the forecast period.

Market segmentation and coverage

This research report categorizes generic inhalants and nasal sprays to forecast revenues and analyze trends in each of the following submarkets:

  • On the basis of indication, the market has been studied for allergic rhinitis, asthma, and COPD.

  • On the basis of age group, the market has been studied on adults, 2-5 year olds, and 6-12 year olds.

  • Based on class, the market has been studied on Allergy Blockers, Anticholinergics, Antihistamines, Decongestants, Mast Cell Inhibitors, and Nasal Steroids.

  • Based on Route, the market has been studied for Inhalation, Nasal Spray, and Tropical Lotion.

  • Based on the distribution channel, the market has been studied in hospital medical stores, online pharmacies and retail pharmacies.

  • Based on region, the market has been studied in Americas, Asia-Pacific and Europe, Middle East & Africa. The Americas are studied in more detail through Argentina, Brazil, Canada, Mexico and the United States. The United States is studied in more detail through California, Florida, Illinois, New York, Ohio, Pennsylvania and Texas. Asia-Pacific is studied in more detail through Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand. Europe, the Middle East and Africa are studied in more detail in France, Germany, Italy, the Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, the United Arab Emirates and the United Kingdom.

Companies cited

  • Allergan AG

  • Altaire Pharmaceuticals Inc.

  • Beximco Pharmaceuticals Ltd

  • Catalent Pharmaceutical Solutions

  • Cipla Limited

  • Hikma Pharmaceuticals PLC

  • Mylan AG

  • Navajo Manufacturing Company Inc.

  • Nephron Pharmaceutical Company

  • Perrigo Company plc

  • Favorite Pharmaceuticals Inc.

  • Sandoz International GmbH

  • Sheffield Pharmaceuticals LLC

  • Sun Pharmaceutical Industries Ltd.

  • Teva Pharmaceutical Industries Ltd.

Cumulative impact of COVID-19

COVID-19 is an unparalleled global public health emergency that has affected almost every industry, and the long-term effects are expected to impact industry growth over the forecast period. The analyst’s ongoing research amplifies its research framework to ensure inclusion of the underlying issues of COVID-19 and potential pathways forward. The report provides insights into COVID-19 considering shifts in consumer behavior and demand, shopping patterns, supply chain rerouting, current market force dynamics, and significant interventions governments. The updated study provides insights, analysis, estimates, and forecasts considering the impact of COVID-19 on the market.

Competitive Strategy Window

The strategic competitive window analyzes the competitive landscape in terms of markets, applications and geographies to help the vendor define an alignment or match between its capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for vendors to adopt successive strategies of merger and acquisition, geographic expansion, research and development, and new product introduction strategies to execute further business expansion and growth. during a forecast period.

FPNV positioning matrix

The FPNV Positioning Matrix evaluates and ranks vendors in the Generic Inhalation and Nasal Sprays Market based on business strategy (business growth, industry coverage, financial viability, and channel support) and product satisfaction (value for money, ease of use, product features, and customer support) that helps businesses make better decisions and better understand the competitive landscape.

Market share analysis

The market share analysis offers the analysis of the vendors considering their contribution to the overall market. It gives the idea of ​​its revenue generation in the overall market compared to other providers in the space. It provides information on the performance of vendors in terms of revenue generation and customer base compared to others. Knowing the market share gives an idea of ​​the size and competitiveness of suppliers for the reference year. It reveals the characteristics of the market in terms of accumulation, fragmentation, dominance and merger.

Competitive scenario

The competitive scenario provides an analysis of the prospects of the various business growth strategies adopted by the vendors. The news covered in this section provides valuable insights at various stages while keeping abreast of activity and engaging stakeholders in the economic debate. The competitive scenario represents press releases or company news categorized into merger and acquisition, agreement, collaboration and partnership, new product launch and improvement, investment and funding, and awards, recognition and expansion. All the news gathered helps the vendor to understand the gaps in the market and the strength and weakness of the competitors, thus providing insights to improve the product and service.

Main topics covered:

1. Preface

1.1. Study objectives

1.2. Market segmentation and coverage

1.3. Years Considered for Study

1.4. Currency and price

1.5. Language

1.6. Limits

1.7. Hypotheses

1.8. Stakeholders

2. Research methodology

3. Executive Summary

4. Market Overview

4.1. introduction

4.2. Cumulative impact of COVID-19

5. Market dynamics

5.1. introduction

5.2. Drivers

5.2.1. Low cost associated with generic prescription drugs

5.2.2. Increased prevalence of asthma and COPD disorders

5.2.3. High cost of health care in developed regions

5.3. Constraints

5.3.1. Strict regulations for generic drugs

5.4. Opportunities

5.4.1. Blockbuster drug patents expiring and FDA approvals rising

5.4.2. Inclination towards generic drugs in developed countries due to rising cost of healthcare

5.5. Challenges

5.5.1. Pressure on prices due to the presence of several players in the segment

6. Generic Inhalation and Nasal Spray Market, By Indication

6.1. introduction

6.2. Allergic rhinitis

6.3. Asthma

6.4. COPD

7. Generic Inhalation and Nasal Spray Market, By Age Group

7.1. introduction

7.2. Adults

7.3. Children 2 to 5

7.4. Children from 6 to 12 years old

8. Generic Drugs for Inhalation and Nasal Sprays Market, By Class

8.1. introduction

8.2. allergy blocker

8.3. Anticholinergic

8.4. Antihistamine

8.5. Decongestant

8.6. mast cell inhibitor

8.7. nasal steroid

9. Generic Inhalation and Nasal Spray Drugs Market, By Way

9.1. introduction

9.2. Inhalation

9.3. nasal spray

9.4. Tropical Lotion

10. Generic Drugs for Inhalation and Nasal Sprays Market, By Distribution Channel

10.1. introduction

10.2. Hospital medical store

10.3. Online pharmacy

10.4. Pharmacy retail

11. Americas Generic Inhalation and Nasal Sprays Market

12. Asia-Pacific Generic Inhalation and Nasal Spray Market

13. Europe, Middle East and Africa Generic Inhalation and Nasal Spray Drugs Market

14. Competitive landscape

14.1. FPNV positioning matrix

14.1.1. Quadrants

14.1.2. Business strategy

14.1.3. Product Satisfaction

14.2. Market Ranking Analysis

14.3. Market share analysis, by key player

14.4. Competitive scenario

14.4.1. Merger & Acquisition

14.4.2. Agreement, collaboration and partnership

14.4.3. Launching and improving new products

14.4.4. Investment & Financing

14.4.5. Reward, recognition and expansion

15. Enterprise Usability Profiles

For more information about this report visit https://www.researchandmarkets.com/r/1lry5e

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211216005562/en/

contacts

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Generic drugs

Generic drugs: are they on par with more expensive brands?

Animation: Farah Hamade

In the United States, more than three-quarters of prescriptions are for generic drugs, non-branded drugs that can cost less than half of their branded counterparts. Generic drugs saved Americans and our health care system over $ 300 billion in 2019 alone.

The use of generics has more than doubled over the past decade, thanks to legislation favoring the production of generic drugs and the expiration of patents on widely used drugs. Despite this enormous growth, myths about the quality of generics persist. The drug safety experts at UCSF help us understand what is the same and what is different, and whether the brand should affect your choices.


MYTH # 1:

Generic drugs are second-rate fakes.

Non-branded products like spaghetti sauce or facial tissues often have a reputation for being worse – they may taste poor or be less durable than the products they imitate. Consumers sometimes associate generic drugs with second-rate fakes because of their lower prices; there is even skepticism among some suppliers.

It is time to get rid of this lingering myth once and for all. Generic drugs are not like other non-branded products, explains Candy Tsourounis, PharmD, professor of clinical pharmacy. They are in their own highly controlled category.

The myth of poor quality can be reinforced by the look, feel or taste of generics compared to brand name drugs that consumers are familiar with. This is because the inactive fillers, coatings, or liquids that help release the active ingredient – the drug itself – can vary.

“A lot of people see generics as somehow inferior due to observable differences,” says Tsourounis, as generics manufacturers modify these inactive components. It also explains why brand-name over-the-counter treatments like headache or allergy medications are different from over-the-counter generics. “For example, the brand name can be a tablet with a glossy coating that tastes good and lowers easily, while the generic can be a chalky white pill with a bitter aftertaste.”

“These differences exist, but the pharmacology – how the drug works in the body, the drug it contains and how long it takes to get to where it needs to be in the body – is the same,” explains Tsourounis, who oversees The UCSF Health Drug Formulary, the list of safe and effective drugs approved for use in the institution. “These are the most critical pieces,” she says. “The rest is just aesthetic.”


MYTH # 2:

Generic testing is not that rigorous.

Generic drugs don’t go through the same testing protocols as brand-name drugs, but there’s a good reason, explains Tsourounis.

“It’s not that the tests are less rigorous, but it’s different,” she says. It takes eight to 12 years of research and development, including clinical trials, to make sure a new drug is safe and effective. All the steps involved in bringing a drug to the market represent significant costs for the company holding the patent.

However, generics are not new drugs. When the patent becomes available on an existing approved drug, a generic manufacturer simply purchases or produces the already developed, tested and approved active component and formulates it into a tablet, capsule or other delivery vehicle. “This timeline is month, not years, ”says Tsourounis, so it costs a lot less to bring a generic drug to the market. When multiple manufacturers produce the same generic drug, competition drives prices down further.

The FDA requires that generics contain the same active ingredient as the branded version, have the same strength and format (such as a tablet or capsule), and use the same route of administration (such as by mouth or injection. ). To prove that their formulations work like the original drug, generic manufacturers must meet strict bioequivalence requirements, which means that the drug must be absorbed by the body and measurable in the blood at comparable levels, in a strict range, to those of the brand. drug name.

Tsourounis also points out that FDA regulations govern every detail of pharmaceutical manufacturing, from laboratory facilities to the training required for people who handle and package drugs.

Shalini Lynch, PharmD ’92, associate professor of clinical pharmacy, co-authored a study that found that generic drug skepticism is higher among auxiliary providers like nurses and medical assistants, who receive limited training in pharmacology, than among doctors. “Additional training on specific concepts such as bioequivalence,” explains Lynch, “could… promote a better understanding of the generic approval process.”


MYTH # 3:

Generics just don’t work as well as brand name drugs.

Especially when people switch from a brand name drug to a generic drug, they can experience modest changes. Tsourouni says to avoid jumping to the conclusion that the credits don’t measure up.

“There is a lot to assess before concluding that the generic drug does not work as well as the brand,” she says. Are there interactions with food or other drugs that affect the way the drug is absorbed? Does the person take the medicine at the same time each day? When she hears complaints that a drug didn’t work as quickly or caused a side effect, “there is usually no pharmacological reason for these effects, so I turn to other causes or maybe. even be a placebo effect based on these myths that generics aren’t as good, ”she said.

Pharmacies stock both generics classified as AB – drugs with the highest bioequivalence ratings – and drugs classified as B, which still meet strict FDA requirements but have slightly lower bioequivalence. Generics classified as B may be better suited for the initial use of a drug rather than replacing a branded version. While Lynch warns that additional monitoring may be needed for patients with conditions where small changes in blood levels could pose “immediate and serious risks,” she says the warning is about the situations and risks individual, not drug classes. Lynch and Tsourounis say that it is beneficial for all patients to discuss generic drug options with their doctor.

“The bottom line is that generic drugs provide the same active ingredient as the brand at a lower cost, and they should be used whenever appropriate,” Tsourounis explains. “These are good drugs. “

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Generic drugs

Generics and biosimilars get last-minute stay of rebates with Senate adjustments for Build Back Better Act – Endpoints News

The Senate Finance Committee on Saturday released the latest text of President Joe Biden’s $ 2 trillion spending plan, paid at least in part with new bargaining power for Medicare and inflation discounts that manufacturers of drugs will have to pay if their drug prices rise too quickly each year.

But now generic drugs threatened with shortages and biosimilars have been excluded from discounts, as demanded by their industry lobby groups. They said the inclusion of such discounts and negotiations could increase the likelihood of drug shortages and create barriers to competition.

According to the latest version of the text of the bill, generic Part D drugs that are in short supply may be exempted, as well as biosimilars, and the secretary of the HHS may make certain decisions that a drug may be eligible for a reduction. or a waiver, if access to the drug would be severely reduced.

Unlike Medicaid, under current law Medicare does not have the power to limit annual price increases for drugs covered by Part B or D. Rebuild Better Act would require drugmakers, starting in 2023, to remit the federal government if their prices for single-source drugs and biologics rise faster than the rate of inflation, according to KFF.

Manufacturers who do not pay this discount would be penalized and forced to pay at least 125% of the original discount.

The Congressional Budget Office (before the exclusion of generics and biosimilars) estimated that the net reduction in the federal deficit through rebates would be around $ 84 billion over 10 years (through 2031). The CBO also estimated that about 10 fewer drugs (out of a calculated total of 1,300 drug approvals) over 30 years would not be developed because of the lost money.

Finance Chairman Ron Wyden (D-OR) said in a statement: “Our package is historic. It would create well-paying jobs, lower the cost of raising a family, tackle the climate crisis and lower energy bills, build more affordable housing, and lower health care costs for families and the elderly.

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Generic drugs

For pushing generics, Valley set to get 45 more ‘Jan Aushadhi stores’ – Jammu Kashmir Latest news | Tourism

In 2 phases, 50 stores of this type are already operating

Irfan Tramboo

Srinagar, December 12: After setting up around 50 Jan Aushadhi stores in Kashmir, the Ministry of Health has initiated the process of establishing 45 more such stores as part of phase III to ensure that Kashmir patients are getting quality drugs by pushing generic drugs into the market by strengthening the chain of these stores.
Officials told Excelsior that as part of the latest Phase III, the department will establish 45 additional Jan Aushadhi stores across Kashmir under Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) in hospitals that operate around the clock.
Under phase III, 2 other Jan Aushadhi stores will be installed in Srinagar at PHC Zadibal and Khanmoh, 6 at Budgam at CHC Pakharpora, Kremshore, PHC Khag, Poshkar, Surasyar and Hardpanzoo.
In Pulwama district, the department is ready to open 5 Jan Aushadhi stores in PHC Awantipora, Kakpora, Khrew, Litter and Aribal; in Ganderbal, 5 other stores of this type will be installed at MMC Watlar, PHC Tulmulla, NTPHC Gutlibagh, Ganiwan and PHC Wussan.
In Baramulla, the department plans to open 5 stores of this type in PHC Boniyar, Kunzer, Dangiwacha, Tarzoo and Kreeri; in Kupwara, 9 of these stores will be opened in CHC Sogam, Kralpora, Zachaldara, Langate, Kralgund and Villgam, Trejgam, Kalaroose and Chogal.
In Bandipora, 4 other stores of this type will be opened in CHC Dawar, PHC Chuntimulla, Ashtingoo and NTPHC Naidkhai; in Anantnag, in the same way, 3 other stores are planned which will be born in SDH Dooru, PHC Larnoo and NTPHC Pahalgam.
In Shopian 2, such stores were provided at PHC Sedow, DK Pora; at Kulgam 4, such stores will appear at PHC Qaimoh, Qazigund, Mohammad Pora and PHC Nihama.
It should be noted here that the process of creating Jan Aushadhi stores was started in 2019 and as part of phase I of it, 23 stores were created, followed by phase II in which 32 of these stores have been approved. , bringing the total number of Jan Aushadhi stores in Kashmir hospitals to 55, including one in Leh and Kargil.
Previously, the additional chief secretary H&ME had asked officials to increase the number of Jan Aushudi stores across Kashmir, and according to the instructions, the marketing directors were invited to submit the proposals accordingly for the establishment of new stores in their districts.
Officials say the process is currently underway and in a week or so they will have approval for Jan Aushadhi stores under Phase III.
Within the framework of the PMBJP, by creating Jan Aushadhi stores, it aims to guarantee access to quality drugs for all sections of society and at the same time to promote generic drugs.
Nodal Officer Jan Ashudi for the Kashmir Division, Dr Nishat Shaheen told Excelsior that DHSK is currently processing the documents and the process is being carried out according to guidelines.
Interestingly, Jan Aushadhi’s drug prices are 50-90% lower than brand-name drugs on the open market, while the drugs are purchased only from suppliers certified by the World Health Organization. – Good manufacturing practices (OMS-GMP) to ensure product quality. (PTI)

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Prescription drugs

Does Medicare Cover Prescription Drugs?

TThe good news is that when you are eligible for Medicare, you will also be able to purchase insurance that pays a portion of the costs of your prescription drugs – in many cases, most of the costs. But there are many caveats about Medicare drug coverage and significant variations in coverage and costs between plans.

Original health insurance (parts A and B) does not cover prescription drugs except in special cases (drugs administered during surgery for example). Original Medicare beneficiaries are eligible to purchase prescription drug coverage, called Medicare, Part D, which is sold and administered by private insurers.

More Advantage of Medicare plans, on the other hand, include coverage for prescription drugs.

In both cases, Medicare Part D and Medicare Advantage, it is important to remember that the specific drugs covered vary from plan to plan. The same goes for monthly premiums and other fees. It is therefore beneficial to educate yourself, shop carefully and re-evaluate your choice of package each year.

What Medicare Part D plans cover

Medicare drug plans cover both generic and brand name drugs. All plans cover certain categories of drugs to treat specific conditions. Each plan decides which specific drugs to insure by category.

Each Medicare Part D plan lists the drugs it covers on a formulary, which typically includes both brand name drugs and generic drugs. Forms change, so it is very important to regularly check that your medications are included.

You should also check each plan for restrictions on drug coverage, such as requirements that certain drugs must be approved in advance by the insurer.

If you or your provider thinks that none of the covered medications will adequately treat your condition, you can request a exception.

What you will pay for prescriptions

In addition to Part D premiums, you may be responsible for cost sharing, which may include deductibles, copayments, or coinsurance. Medicare Part D plans set their own premiums.

Part D plan deductibles vary from $ 0 to the maximum allowed, which in 2021 is $ 445 (rising to $ 480 in 2022). Those with higher incomes will pay an additional monthly fee of $ 12.30 to $ 77.10 for Part D in 2021.

Co-payments or coinsurance

Almost all Medicare Part D and Medicare Advantage plans with prescription drug coverage charge a copayment or coinsurance. Buy with care; your costs will vary from plan to plan.

Part D coverage requires you to pay varying prices for different categories of drugs. In general, your cost share will be higher for brand name drugs.

Note that if you delay your Part D registration for too long, you will have to pay a late registration penalty.

How To Compare Medicare Part D Plans

Medicare.gov can help you find a Part D plan that covers your prescriptions and can help you compare your costs under various Medicare Part D and Medicare Advantage plans.

More from NerdWallet

John Rossheim writes for NerdWallet. Email: [email protected]

Does the Medicare article cover prescription drugs? originally appeared on NerdWallet.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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Prescription drugs

Prescription drug price hikes are slowing, but many patients say costs are still crippling

An Oregon law passed in 2018 requires drug companies and health insurers to file data with the state on prescription drug prices. Each year in December, this information is compiled into a report and released to lawmakers and the public.

In a virtual hearing on Wednesday, state officials gave an overview of some highlights of the 2021 report.

Numi Lee Griffith is Senior Policy Advisor at the Department of Consumer and Business Services. She said the data shows a sharp reduction in price increases reported in recent years.

“What we have seen is that there has been a decrease in the number of price increases,” she said, “as well as a decrease in the magnitude of the price increases”.

Griffith suggested that this is at least in part because drugmakers launched newer drugs at a higher price to begin with, so they have to report fewer increases to state officials later.

But according to testimony at the hearing, even with the easing of average price increases, people facing serious illnesses in the state are still struggling to afford their treatment.

Joan Morgan is part of the Oregon Coalition for Affordable Prescriptions. She said her father’s cancer drug had gone from an already unaffordable $ 4,000 to $ 10,000 a month. The only saving grace, she said, was a brother who brought the same medicine from Europe, where it cost $ 243.

“Think about it just for a second,” Morgan told the hearing panel lawmakers. “Do the math. Because it blows my mind even after we’ve been doing this for years.”

Other data highlights from the 2021 annual report include:

  • There were 193 new “expensive” drugs reported. These are drugs that are priced at wholesalers $ 670 or more for a 30 day supply.
  • The most expensive drugs in this group were the cancer chemotherapy drugs Abecma and Breyanzi, produced by Bristol-Meyers Squibb. They cost $ 419,500 and $ 410,300 respectively.
  • State data shows that, by far, cancer treatments make up most of the new high-cost drugs introduced.
  • 71 drugs reported annual price increases, the largest of which was a 778% increase for a generic drug from Nostrum Labs.
  • The average price increase for generic drugs was 27%, 13% for brand name drugs

The 2021 Prescription Drug Price Transparency Report is expected to be released on December 15.

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Generic drugs

Corporate Rx for Distressed Healthcare System: Affordable Generics Made in USA

Nexus Pharmaceuticals founder Mariam Darsot believes in altruistic acts like funding a labor and delivery ward in Sierra Leone, the country with the highest maternal mortality rate in the world. Photograph of Evan Jenkins

Nexus Pharmaceuticals is a 2021 Inc. Best in Business winner. With the second annual Best in Business, Inc. award recognizes companies that have made an exceptional impact on their industries, communities, the environment and society as a whole.

Meet the Illinois-based family-owned pharmaceutical company investing in nationwide manufacturing of drugs as treatment for the struggling healthcare industry.

Nexus Pharmaceuticals unveiled a state-of-the-art manufacturing facility in Pleasant Prairie, Wisconsin in June, doubling down on its mission to make high-quality generic drugs more affordable and accessible to patients in the U.S. The company’s three-story building, an investment of $ 250 million that will eventually employ more than 400, is the first national project of its kind in three decades. Meanwhile, production of US pharmaceuticals has largely shifted overseas so companies can take advantage of reduced environmental regulations and a lower-cost workforce. Today, only 28 percent of the active pharmaceutical ingredients supplied to the United States are produced here.

This over-reliance on foreign manufacturers has resulted in supply chain issues, quality-related recalls, and reduced export availability. All of this has contributed to rising pharmaceutical prices and national shortages, according to Mariam Darsot, CEO and founder of Nexus. And that, she says, prevents people from getting the timely treatment they might need. Also at the start of the pandemic, Indian manufacturers reduced exports of more than 20 essential pharmaceuticals and active ingredients to meet patient demand in their own country, which only added to the already heavy burden. of American health. the care industry, explains Darsot.

“I think it’s fair to say that the pharmaceutical industry has damaged its reputation a lot through price fixing allegations, substandard products from overseas or price increases. essential drugs, ”Darsot said. And she is committed to changing the industry, from the inside out. Since its inception in 2003, Nexus has prioritized the production of injectable drugs with historically rare critical needs. It has a long history of working with contract manufacturers to produce its FDA-approved generic pharmaceuticals, and now, with its own manufacturing facility, it can scale up its production even further to have a serious impact on the overall drug supply of consumers. United States. (Especially considering the fact that most of the drug shortages in the country are in generic drugs, Nexus’ specialty, the promise is clear.)

Over the past year, the company has already increased the US supply of two rare and life-saving pharmaceuticals: an injection of succinylcholine chloride, a drug in high demand to treat Covid patients, and an injection of potassium chloride, an IV solution with historically few manufacturers (including the one damaged in Hurricane Maria, resulting in a lasting shortage).

Darsot says she’s not interested in profit for profit – the company explicitly produces drugs that are needed in an attempt to lower healthcare costs for consumers. Nexus avoids private equity so as not to be influenced by shareholders. His altruism also extends beyond his core business. In 2020, for example, Nexus funded a labor and delivery unit at the Tanihanun health center in Sierra Leone, the country with the highest maternal mortality rate in the world. In 2021, the company also donated $ 176,000 to charitable organizations through employee matchmaking and community partnerships.

“Being a family business allows us to give back to a community that has given so much to our business and our family,” said Darsot. “This brings us back to our core mission of helping deliver affordable medicines to those who need them most.”

EXPLORE MORE Best in business COMPANIESRectangle

Extract from the Winter 2021/2022 issue of Inc. Magazine

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Generic drugs

Medkart: Generic Medkart Retail Chain Raises Rs 40 Crore In Series A Cycle

Medkart, the Ahmedabad-based generic drug retail pharmacy chain, said on Tuesday it had raised Rs 40 crore in its Series A cycle from Alkemi Growth Capital and Insitor Partners with the participation of angel investors , including Prashant Poddar and other UAE professionals and former CEOs of IIFL Asset Management.

Medkart, founded by Ankur Agarwal and Parsharan Chari, is an omnichannel pharmacy that helps people lower their medical bills through access to the best quality generic drugs at the most affordable rates.

Founded in 2014, Medkart provides generic medicines certified by WHO GMP in its network of more than 75 stores in more than 22 cities.

Medkart says it cuts medical costs by up to 85% and has saved more than Rs 200 crore for its clients to date.

The company said it has a loyal base of over 600,000 chronic disease patients and derives 80% of its revenue from loyal customers.

The company has so far focused on building a robust supply chain and improving final delivery to customers.

During its founding years the company was started up, quickly achieved a positive unity economy, and gradually expanded its operations across Gujarat and Rajasthan. More recently, she has embarked on building online channels to add a more personalized experience to the customer.

Speaking about fundraising, Ankur Agarwal, Co-Founder, said, “Every year 6 crores of Indians are plunged into poverty due to medical expenses. Considering that drugs are a basic need especially for chronic patients, we aim to disrupt the way drugs are consumed in India. As a technology company, we always aim to serve our customers no matter which channel they are comfortable with. ”

Mumbai-based investment bank Radix Capital Advisors acted as exclusive financial advisor to Medkart.

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Generic drugs

Generic Drugs Market Size To Exceed US $ 574.63 Billion

Ottawa, November 09, 2021 (GLOBE NEWSWIRE) – According to the new study report released by Precedence Research, titled “Generic drugs market by drug type, brand, drug route of administration, therapeutic application and distribution channel: analysis of global opportunities and industry forecast, 2021-2030 ”, the increasing prevalence of chronic diseases, especially cardiovascular disorders, has propelled the market demand for generic drugs.

Generic drugs are crushing the pharmaceutical industry market with record growth and a sustainable market trend, making it a lucrative area in which to operate.

The report is ready | To have Sample copy of the report OR any customization requirements @ https://www.precedenceresearch.com/customization/1205

A generic drug contains the same chemical substance as a drug that was previously protected by a chemical patent. After the patents on the original pharmaceuticals expire, generic drugs can be sold. The medical profile of generics is considered to be equal in terms of performance because the active chemical ingredient is the same. The generic drug contains the same active pharmaceutical ingredient (API) as the brand name drug, but it can change in terms of manufacturing technique, formulation, excipients, color, taste and packaging. The profitability of generic drugs has contributed to a competitive advantage over brand name drugs is the main factor adding to the growth of the market.

The crucial factors responsible for the growth of the market are:

  • The low cost of generics as an alternative to brand name drugs
  • Large number of brand name drug patents expired
  • Initiatives from governments and other regulatory bodies around the world

The expiration of brand name drug patents to open up new avenues for generic drug players to enter on the market

The expiration of brand name drug patents continues to increase, offering huge potential opportunities in the drug market. Generic drug manufacturers have constantly focused on developing and launching various innovative drugs as well as formulations such as biosimilars which are helping in the growth of the market. In addition, government initiatives to promote the manufacture of generic drugs for deadly chronic diseases have further stimulated the market growth in emerging economies in particular. In addition, the growing aging populations across the world who are more prone to various diseases have fueled the growth of the market.

Global Generic Drugs Market Size and Estimates, by Brand, 2021-2027 (USD Billion)

Brand segment 2021 2023 2025 2027 TCCA (2021-27)
Brand generics 200.60 234.66 272.41 313.86 7.75 %
Pure generics 213.96 230.32 246.06 260.77 3.35 %
Total 414.56 464.98 518.45 574.63 5.59 %

Oral generics seeking an advantage due to their most popular route of drug administration

Major advantages associated with oral generics such as convenience of oral drug administration, patient preference, cost-effectiveness, and ease of large-scale manufacture of oral dosage forms, oral medication is the most common route of administration. more widespread. About 65 percent of commercially available generic drugs are taken orally. Oral formulations account for approximately 90% of the global market share of all pharmaceutical formulations intended for human use, according to current estimates. Orally administered pharmaceuticals make up about 84 percent of the top-selling pharmaceuticals. They are the main contributor to the growth of the market due to the preferred and cheap option. Additionally, they are patient friendly, especially in geriatric and pediatric populations, and are relatively easy to create compared to their large molecule rivals.

HIGHLIGHTS OF THE STUDY

  • The oral segment of the administration route is estimated to grow at a remarkable rate and represent the largest share throughout the study period.
  • Brand-name generics dominate the generic drug market in 2020, but pure generics are expected to overtake brand-name generics by 2027.
  • The Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period owing to the rapid penetration of local players in the market.
  • North America dominated the generic drug market and is expected to maintain its trend throughout the forecast period.
  • The Cardiovascular segment of Therapeutic Applications segment posted significant revenue share in the year 2020, while the Oncology segment was poised to grow at the fastest rate for the foreseeable future.
  • The retail pharmacy holds the leading position in the distribution channel segment; however, online distribution grows at a significant rate during the forecast period.

Asia Pacific region to gain ground in the global generic drug market due to lower manufacturing cost and highly skilled labor

Asia-Pacific is expected to show significant traction in the market during the forecast period. This is attributed to lower manufacturing costs and highly skilled labor in Asian countries. According to the India Brand Equity Foundation, India has the second largest number of US FDA manufacturing plants outside of the United States that are involved in the manufacture of generic drugs. In addition, the manufacturing cost is 33% lower in India than in the United States, which increases the accessibility of generics in these countries.

Global Generic Drugs Market Size And Estimates, By Region, 2021-2027 (Billions USD)

Region 2021 2024 2027 TCCA (2021-27)
North America 149.46 165.00 178.77 3.03 %
Europe 121.34 136.67 151.47 3.77 %
Asia Pacific 98.08 130.01 168.14 9.40 %
Latin America 29.99 38.88 49.36 8.66 %
Middle East and Africa 15.69 20.79 26.89 9.40 %
Total 414.56 491.35 574.63 5.59 %

Asia-Pacific has placed a strong emphasis on increasing the supply of drugs at lower prices, even if this requires purchasing from non-traditional sources, with a historically low rate of drug use. generics. Hence, emerging countries such as India and China are complementing the growth of the generics market.

In 2019, generic and biosimilar pharmaceuticals saved the U.S. healthcare system $ 313 billion, including $ 96 billion in Medicare savings and $ 48.5 billion in Medicaid savings. Generics fill 90% of prescriptions in the United States for just 20% of the cost, at a time when access to reliable, cheap, high-quality prescription drugs is more critical than ever. In 2019, the average primary co-pay for generics was $ 6.97 compared to the average primary co-pay for brand-name drugs of $ 56.32. These supporting factors are expected to drive generic drug sales over the next few years.

Browse more health industry research reports @ https://www.precedenceresearch.com/industry/healthcare

Market competitiveness and business prospects

The global generic drug market is fragmented due to the presence of several large and small companies spread across the world. The main market players are adopting new strategies to gain attractiveness on the market. The report provides in-depth competitive analysis and profiles of major market players such as Mylan NV, Abbott Laboratories, ALLERGAN, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, STADA Arzneimittel AG, GlaxoSmithKline Plc., Baxter International Inc., Pfizer Inc., Sandoz International GmbH and others. Other players operating in the value chain are AurbindoPharma, Sun Pharmaceutical Industries Ltd., Aspen Pharmacare, Fresenius Kabi Ag, Lupine, Novartis, Glenmark, Sawai, PiramalPharma Solutions, Hikma, Cipla, Dr. Reddy’s, Endo, Stada and Mallinckrod between others.

Main market segments covered:

By type of drug

By brand

By drug administration

By therapeutic application

  • Central nervous system (CNS)
  • Cardiovascular
  • Dermatology
  • Oncology
  • Respiratory
  • Others

Key distribution channel

  • Hospitals Pharmacies
  • Retail pharmacies
  • Others

By geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa (MEA)

Click here for See the table of contents of the full report

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About Us

Precedence Research is a global market research and consulting organization. We provide an unmatched nature of offering to our customers around the world, in all industry verticals. Precedence Research has expertise in providing in-depth market intelligence as well as market intelligence to our clients across various companies. We are obliged to serve our various clienteles present in companies of medical services, health, innovation, new generation technologies, semiconductors, chemicals, automotive, aerospace and of defense, among various companies present in the world.

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Generic drugs

Global Generic Drugs Industry To 2026 – North America Has Dominated Overall Market And Expected To Maintain Dominance

DUBLIN, November 09, 2021– (BUSINESS WIRE) – The report “Generic Drugs Market – Growth, Trends, COVID 19 Impact and Forecast (2021 – 2026)” has been added to ResearchAndMarkets.com offer.

The global generic drugs market is valued at around USD 263 billion in 2020 and is expected to register a revenue of USD 385 billion in 2026, with a CAGR of 6.58% over the forecast period.

Companies mentioned

  • Mylan NV

  • Abbott Laboratories

  • Abbvie (Allergan)

  • Teva Pharmaceutical Industries Limited

  • Eli Lilly and company

  • STADA Arzneimittel AG

  • GlaxoSmithKline Plc.

  • Baxter International Inc.

  • Pizer Inc.

  • Sandoz International GmbH

  • Sanofi

  • Sun Pharma

Key market trends

Injectables segment is expected to gain significant share of the studied market during the forecast period

Tablets, capsules, pills are not the only way to deliver the drug into the body, the injectable is another way to deliver the drug, and this is considered to be the most efficient way because of the bioavailability of the drug by this route is higher than the other routes. Nowadays, new advances are occurring in this segment of injectables. This way, the drug takes less time to react.

Recent developments in needleless injectors have contributed to its growth. For example, Bespak Europe Limited works closely with its biopharmaceutical partners to develop a personalized device for the needs of specific patient groups. Additionally, the prevalence of diabetes, cardiovascular issues, cancer, and several other chronic conditions will help injectables grow further during the forecast period.

Moreover, based on the application segment, Cardiovascular Drugs contribute more to generate the overall revenue of Generic Drugs, as the cases of cardiovascular diseases are increasing year by year around the world, especially heart failure, heart failure, High blood pressure, high cholesterol, angina, strokes and a few others are also involved. The increase in cardiovascular cases is due to lack of physical exercise, eating habits which mainly contain fat and sugar, other reasons are also involved. As the cardiovascular cases increase, the demand for their treatment will also increase so that the market will experience significant growth during the forecast period.

North America has dominated the overall market and is expected to retain its dominance

North America holds the maximum share of revenue generation from generic drugs. The reason for this high turnover is due to the presence of many players in the countries of North America and they continue to focus on the introduction of new products and the market as well as on the state prescription model. United, which consists mainly of brand name generic drugs. . Hence, the global generic drugs market will tend to grow here during the forecast period.

Asia Pacific has shown the fastest growing trend in the global generic market due to the increased awareness of people related to any disorder, the increase in population can also be attributed to the increase in the demand for generic drugs. Countries like India, China in Asia-Pacific contribute more than other nations.

India is the main supplier of generic drugs to the United States and European countries. According to the recent FDA report, there are around 40 major generic pharmaceutical companies in India. India has many pharmaceutical companies which manufacture a large number of generic drugs, for example Alkem Laboratories, Sun Pharma, Aurobindo Pharma Limited, several others are also present. Hence, the global generic drugs market will tend to increase during the forecast period.

Main topics covered:

1. INTRODUCTION

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

4.1 Market overview

4.2 Market drivers

4.2.1 Growing prevalence of chronic diseases

4.2.2 Increase in the geriatric population

4.2.3 Increase in health spending

4.3 Market restrictions

4.3.1 Strict government regulations

4.3.2 Adverse drug reactions

4.4 Porter’s five forces analysis

5 MARKET SEGMENTATION

5.1 By route of administration

5.2 By application

5.3 By distribution channel

5.4 Geography

6 COMPETITIVE LANDSCAPE

6.1 Company profiles

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information on this report, visit https://www.researchandmarkets.com/r/hpxgga

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211109005860/en/

Contacts

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Laura Wood, Senior Press Director
[email protected]
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Generic drugs

2 US Sun Pharma units to pay $ 85 million in MDL generic drugs

By Hailey Konnath (Nov 5, 2021, 10:04 p.m. EDT) – Two U.S. subsidiaries of Indian drugmaker Sun Pharma have agreed to pay a combined $ 85 million to a proposed class of direct buyer applicants under a large multidistrict dispute over the alleged price. fixing of generic drugs, the companies reportedly disclosed.

Taro Pharmaceuticals USA Inc. will pay $ 67.6 million to settle the antitrust dispute in Pennsylvania federal court, the company revealed Thursday in a filing with the United States Securities and Exchange Commission.

Taro has entered into an agreement with César Castillo LLC, FWK Holdings LLC, Rochester Drug Cooperative Inc. and KPH Healthcare Services Inc. on behalf of the putative class of all …

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Generic drugs

Khuba calls on doctors and health workers to promote the use of generic drugs

Calling on doctors, health workers and ASHAs to promote the use of generic drugs, Union Minister of State for Chemicals and Fertilizers Bhagwanth Khuba said on Friday that the drugs significantly reduce the cost drugs for people.

Speaking at Janaushadhi Mitra Sammelan, Mr. Khuba said that 145 generic drugs are available at Janaushadi Kendras and these drugs are sold at a cost less than 70% to 90% of the cost of brand name drugs. “By making generic drugs available at an affordable price, Prime Minister Narendra Modi has helped people save on drugs to a great extent,” he said.

Citing an example, Mr Khuba said that the brand name drug Atorvastatin, which is prescribed to lower cholesterol, costs 12 per pill, while the same drug is available at 0.98 paise at a generic pharmacy.

The Union Minister of State urged the government and private doctors to prescribe more generic drugs. He said that Anganwadi workers and ANMs should educate doctors and the population about generic drugs. He also called on the operators of Janaushadhi kendra to carry out activities to raise awareness about the availability of medicines for hypertension, diabetes and chronic diseases, which are regularly consumed by many people.

During the interaction with Mr. Khuba, some of the representatives of the 82 Jananushadhi Kendra in Dakshina Kannada pointed out the poor quality of some of the drugs provided. Another Kendra operator raised the issue of getting Suvidha sanitary napkins for the price of 1, for which there is good demand. A doctor, who has a Janaushadhi Kendra near his hospital in Puttur, expressed the need for more essential drugs in the kendras.

Khuba said the ministry was taking action to address issues related to the quality and supply of medicines. “It’s an ongoing process and we are responding to your concerns. We sincerely believe in making quality essential medicines available to the population, ”he said. Changes are being made to the Janushadhi Sugam app to give people a clear idea of ​​the drugs available in the kendras, he said.

MP Nalin Kumar Kateel and MP for Mangaluru City South D. Vedavyas Kamath spoke.

Mr. Khubha and Mr. Kateel presented the Janaushadhi Prabhuddi Prize to the Udupi District Administration, the district being the first among Karnataka districts in terms of sales of generic drugs. The two men also presented Janaushadhi Mitra Awards to seven people, including three doctors, for the promotion of Janaushadhi Kendras.

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Generic drugs

Increasing the use of generic drugs is an anti-inflationary tactic

We hear these days of alarming growth in inflation, especially in housing and gasoline. That dreaded “I” word permeates discussions as affordability becomes a dominant issue.

One area that could actually see prices drop, however, is our prescription drug coverage.

We are used to assuming that our health care system is better than that of our southern friends, but in reality Americans have over 90% of their prescription drugs filled with generics, whereas in Canada we we only have about 73%.

Generic drugs have the same ingredients, undergo the same rigorous testing and are just as safe and effective, the only difference is that they are more affordable than branded options. For example, if we increased our prescription drug coverage through generic drugs by just 1%, we could save more than $703 million.

This is a critical public policy area where governments could realize significant savings.

But it is also an area where consumers themselves, and employers, can make significant savings in this time of rising prices. Indeed, this is an area where HR personnel and others making decisions about employee drug plans have the opportunity to save money for everyone involved.

As one insurance broker recently noted, “I’ve never been able to convince a client to include the mandatory generic clause. Given the right information, my clients take this for granted. It is simply a question of education.

We need to make this “evidence” a reality by ensuring that all employers have generic drug substitution policies to encourage patients and prescribers to choose the most cost-effective drugs. This means that the drug plan would reimburse at cost a generic drug rather than a more expensive brand name option, which would result in savings for the employer and for the employee, who would obtain the same medical ingredients at a lower price. cost.

This change means that insurance coverage is further extended to reduce the employee’s out-of-pocket expenses. Such a change would maximize their shared dollars so everyone involved would have more money to redirect to other priorities.

Provinces in Canada deal with designating generic drugs as “interchangeable” with branded versions, and many insurers rely on public formulary listings for mandatory generic substitution policies. Provinces should do a better job of making generic substitution more readily available so that patients and employers can realize this savings potential.

Specifically, in Saskatchewan and Manitoba, interchangeability is limited to publicly funded drugs, which limits access to low-cost generic versions of prescription drugs not covered by government drug plans. Meanwhile, British Columbia, Alberta, Quebec and New Brunswick, for example, leave this decision to the discretion of pharmacists, and only drugs listed on formularies are automatically included.

Instead, we need all provinces to allow generic substitution to be readily available so employees and employers can save money on their drug plans.

As Manulife said, “When it comes to your prescription drugs, why pay more than you have to?

Jim Keon is president of the Canadian Generic Pharmaceutical Association.

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Generic drugs

The pros and cons of generic drugs explored

A patient who takes lorazepam (a generic version of Ativan) for her anxiety tells me that her medications have not worked as before in the past few months. She can’t identify what’s wrong, but she doesn’t like how it makes her feel. She thinks to herself that the pharmacy must have changed providers, but that shouldn’t really matter, because aren’t all generics supposed to work the same? Zoom in on some of the often overlooked facts about generic drugs.

What are generic drugs?

When a new drug is approved, it is patented for up to 20 years, giving the original manufacturer time and space in the market to recoup some of the costs of research and discovery. When the patent expires, other companies are allowed to manufacture a similar drug (a generic) that is “bioequivalent”, which means that it delivers the same active ingredient to the same part of the body, over the same length of time. than the original drug.

Are Generic Drugs Less Expensive?

The cost of producing a generic is much cheaper than the original, and competition from several manufacturers drives the price down even further. The price difference is greatest for drugs whose patents have long expired and whose market is dominated by generics. For example, the average monthly retail price of lorazepam is $ 24, compared to $ 1,386 for Ativan.

Insurance companies encourage patients to choose generics with a lower co-payment and sometimes categorically refuse to cover brand-name drugs. On the other hand, pharmaceutical companies are offering coupons and discounts to offset the direct cost of brand name drugs in order to maintain their market share.

Following:Health Matters: Let the Data Talk – Follow-up Questions on COVID Vaccines

Who takes the generic drugs?

Almost everybody. In 2020, 90% of all prescriptions in the United States were filled with generics, and that number has steadily increased since the Drug Price Competition and Patent Term Restoration Act of 1984. (also known as the Hatch-Waxman Act) opened the regulatory valve. in the manufacture of generic drugs. It is estimated that the use of generic drugs has saved Americans $ 313 billion a year in health care costs.

Are there any downsides to generics?

Quality control is a major concern. Companies reduce their costs by outsourcing production; the vast majority of generic drugs in America are made in India and China, while others rely on raw ingredients from these countries. Factories are not as frequently inspected by the FDA as those located in the United States and may not maintain the same level of production. Some unethical companies have even tampered with data to gain regulatory approval. In 2008, a Chinese batch of contaminated heparin, a crucial blood thinner for open heart surgery, killed at least 81 patients in America and injured hundreds more. Fortunately, these disasters are rare.

More often than not, we see inconsistencies in the quality of generics and, therefore, in their biological effects. Unlike the single-source brand name drug, generics are produced by more than one company in more than one location. Pharmacies change supplier freely depending on price and / or availability. Even though the concentration of the active chemical remains the same, changing inactive ingredients like fillers, binders, and dyes can cause different reactions when you take the pill.

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What should I do if my generic is not working properly?

There are several options. Ask the pharmacist if a version of the medicine from the previous supplier is still available. Change your pharmacy, which will likely change providers. Some drugs have an “authorized generic” which is exactly the same as the brand name, produced by the same company and factory, but sold without the brand name. It is more expensive than other generics, but has quality assurance from the original pharmaceutical company. If you develop a true allergy or severe intolerance to generics, ask your doctor to specify “brand name only” on the prescription, although this may require passing certain hurdles for insurance to pay for it.

Usually we don’t look twice at the pill bottle after filling a prescription. But as we strive to become more informed healthcare consumers, we hope this generic drug information will encourage you to take a closer look, and perhaps say “Yes” when the pharmacy cashier tells you. ask if you have any questions for the pharmacist about your medicine.

Qing Yang and Kevin Parker are a married couple living in Springfield. Dr. Yang received her medical degree from Yale University School of Medicine and completed her residency at Massachusetts General Hospital. She is an anesthesiologist at HSHS Medical Group. Parker has helped formulate and administer public policy in various cities and state governments across the country. He was previously the Group Information Director for Education at the Illinois Department of Innovation and Technology. This column is not intended to be a substitute for professional medical advice, diagnosis or treatment. Opinions are those of the authors and do not represent the views of their employers.

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Generic drugs

Generic Drugs Authorized “Insufficient” to Improve Affordability of Medicare Part D

20 October 2021

2 minutes to read

Source / Disclosures

Disclosures: The authors do not report any relevant financial disclosures.


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Generic drugs licensed for insulin and direct-acting antiviral agents may reduce out-of-pocket expenses for patients, but are unlikely to save money for Part D plans or Medicare, according to the data.

“Compared to brand name drugs, authorized generic versions of direct-acting antiviral agents for hepatitis C and insulin are said to have resulted in lower out-of-pocket expenses for Medicare beneficiaries.” Stacie B. Dusetzina, PhD, associate professor of health policy and Ingram associate professor of cancer research at Vanderbilt University School of Medicine in Nashville, Tennessee, and colleagues wrote in JAMA Internal Medicine. “However, coverage for authorized generic drugs was limited for some Part D beneficiaries, with many beneficiaries covered by plans covering only brand name drugs. For Part D plan sponsors, this decision likely reflects rational economic behavior, as the net prices (after rebates) of brand name drugs in these classes may be similar to or lower than the net prices of authorized generic drugs.

Various colorful pills
Source: Adobe Stock

As Healio previously reported, manufacturers of insulin and direct-acting antiviral agents for the treatment of hepatitis C have recently introduced authorized generic alternatives to their patented branded products at a time when brand name drugs faced no immediate threat of generic competition. Authorized generic drugs have list prices at least 50% below the list price of brand name drugs; the announcements followed close scrutiny in Congress on high drug prices.

In a cross-sectional study, Dusetzina and colleagues analyzed data from the Medicare Prescription Drug Plan form and third quarter 2020 pricing information files and Medicare Part D enrollment for September 2020. Researchers assessed the coverage of four branded formulations of direct-acting insulin and antivirals and their authorized generic formulations: sofosbuvir and velpatasvir fixed-combination tablets (Epclusa, Gilead), ledipasvir and sofosbuvir tablets (Harvoni, Gilead), insulin lispro (Humalog, Eli Lilly) and insulin aspart (Novolog, Novo Nordisk).

“We selected these drugs because we believe they are the only ones to have launched generic formulations authorized more than a year before the expected expiration of the patent and have faced no traditional generic competition in the third quarter of 2020. “the researchers wrote.

The main results were the weighted coverage of the formulary by beneficiaries of branded products and authorized generics; disbursements by the beneficiary; and the prepayment plan, manufacturer and Medicare expenses on branded products and authorized generics.

As of the third quarter of 2020, 97% of beneficiaries were on plans that covered only brand name drugs or both brand name drugs and authorized generics. About 3% of beneficiaries were on plans that covered only authorized generic drugs.

The researchers found that the list prices of authorized generic drugs were 67%, 62% and 50% lower than the list prices of Epclusa, Harvoni and each branded insulin product, respectively. “Medicare beneficiaries using licensed generics could save $ 270 per year for 12 vials of Humalog and $ 2,974 for a full treatment of Harvoni,” the researchers wrote.

The plans, however, have limited incentives to encourage the use of authorized generics; discounts for brands likely exceed savings available with authorized generics, especially for beneficiaries whose spending reaches the Medicare Part D coverage gap.

“Ultimately, the availability of licensed generic options for products that do not face traditional generic competition is insufficient to improve affordability for Medicare beneficiaries,” the researchers wrote. “The results of this study suggest that efforts to change Medicare Part D benefits should also ensure that incentives for plans and beneficiaries are properly aligned and that beneficiaries are not paying too much for drugs that are better.” value for their health plan and Medicare program. “

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Generic drugs

Generic Drugs Market Growth of USD 138.90 billion from 2021 to 2025 | Technavio

Read our free sample report to make the most of future growth opportunities.

The Generic Drugs Market report offers a comprehensive analysis of the strategies adopted by the vendors and the trends, drivers and challenges affecting the market size. The report identifies the low cost alternatives as one of the major growth factors of the market. The advent of RPA, the increase in mergers and acquisitions, and hospital-owned generics will be some of the market trends over the next few years.

The generic drugs market covers the following areas:

Sizing of the generic drug market
Generic Drugs Market Forecast
Generic Drugs Market Analysis

Companies mentioned

  • Amgen Inc.
  • Dr. Reddys Laboratories Ltd.
  • Fresenius SE and Cie KGaA
  • Merck et Cie Inc.
  • Novartis AG
  • Pfizer Inc.
  • Sanofi SA
  • Sun Pharmaceutical Industries Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Viatris inc.

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Associated reports:

  • Lung Cancer Therapeutics Market by Type and Geography – Forecast and Analysis 2021-2025: The lung cancer treatment market has the potential to grow by $ 6.79 billion from 2021 to 2025. Download a free sample exclusive report
  • Interstitial Cystitis Drugs Market by Type and Geography – Forecast and Analysis 2021-2025: The market for interstitial cystitis drugs has the potential to grow by $ 283.95 million from 2021 to 2025. Download a free sample report

Scope of the generic drug market

Cover of the report

Details

Page number

120

Year of reference

2020

Forecast period

2021-2025

Growth dynamics and CAGR

Accelerate to a CAGR of 6.33%

Market growth 2021-2025

$ 138.90 billion

Market structure

Fragmented

Annual growth (%)

5.95

Regional analysis

North America, Europe, Asia and ROW

Efficient contribution to the market

North America at 39%

Main consumer countries

United States, Germany, China, Japan and United Kingdom

Competitive landscape

Leading companies, competitive strategies, reach of consumer engagement

Profiled companies

Amgen Inc., Dr. Reddys Laboratories Ltd., Fresenius SE and Co. KGaA, Merck and Co. Inc., Novartis AG, Pfizer Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd. and Viatris Inc..

Market dynamics

Parent Market Analysis, Market Growth Drivers and Obstacles, Analysis of Fast Growing and Slow Growing Segments, Impact of COVID 19 and Future Consumer Dynamics, Analysis of Market Conditions for the Forecast Period,

Customization

If our report didn’t include the data you’re looking for, you can reach out to our analysts and customize the segments.

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Technavio is one of the world’s leading technology research and consulting companies. Their research and analysis focuses on emerging market trends and provides actionable insights to help companies identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialist analysts, Technavio’s report library includes over 17,000 and more reports, spanning 800 technologies, spanning 50 countries. Their customer base consists of companies of all sizes, including more than 100 Fortune 500 companies. This growing customer base relies on Technavio’s comprehensive coverage, in-depth research and actionable market intelligence to identify opportunities in existing markets. and potentials and assess their competitive positions in changing market scenarios.

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Generic drugs

Generic drugs are cheaper in the US, but quality control can be a problem, says professor | WFAE 90.7

Every week through October, we examine the medical, business, and cultural systems that contribute to the dichotomy that is America’s healthcare system — a system that benefits some but costs us all.

Today we are looking at generic drugs. You may have heard that they are cheaper than brand name drugs and they are just as good, right? Well, changes are afoot in the industry that are testing this long held theory. Dr. Kevin Schulman is a professor of medicine at Stanford University and has studied this question extensively.

Marshal Terry: Welcome.

Kevin Schulman: Thank you very much for inviting me.

Terri: Conventional wisdom has long held that generic drugs are the same as brand name drugs. Is this assumption wrong?

Schulman: They are the same chemical entity. What we learn is that over time, the question we ask ourselves is the quality of the drugs. How are they made? Are they made to the same standards as the original brand name drug?

Terri: And what is the answer to that?

Schulman: Unfortunately, we find that often they fail. There are large classes of drugs — generic drugs — that have been recalled in the past two years because they contain carcinogens that were not suitable for drugs. And that just opens up the question: what’s going on in the generic drug market? How do we understand both the price and the quality of the drugs we receive?

Terri: Well, what’s going on with the generic drug market? What leads to this?

Schulman: Thus, the idea of ​​generic drugs dates back to 1984 with what is called the Hatch-Waxman Act. At the time, the idea was to allow generic drugs into the US market to drive down the price of drugs, and it was mostly a price-driven set of issues. And it worked very well. In 1984, the generic drugs we got in the United States were mostly made in the United States and Europe. Today, these drugs are made overseas – maybe in India, maybe in China.

Our ability to regulate these manufacturers is very different, and the market itself has really changed dramatically. We had a huge concentration of intermediaries in the market — the drug distributors. And this puts enormous pressure on manufacturers’ prices. So today, yes, generic drugs are the cheapest ever. Sometimes the really important drugs are pennies. But this is purely a price market. There is no quality assessment. It’s like going to Amazon and saying, “Give me the cheapest good in any category without the quality rating.” And we all know what that leads to.

Terri: You said more of these generic drugs are now being made outside the United States — overseas, in places like China and India. How much more common is that?

Schulman: Around 2005, 2007, about 50% of all generic drugs in the United States were made overseas. And I think now…the majority of them are made overseas. There are different parts of the drug. The chemicals that go into the drug are almost all made overseas. And then whoever packages the drug and takes those active pharmaceutical ingredients and makes it into a pill or a tablet or a capsule—that’s also usually overseas.

“Yes, generic drugs are the cheapest they’ve ever been. Sometimes the really important drugs cost pennies. But it’s purely a price bargain. There’s no quality assessment. “

— Dr. Kevin Schulman, Professor of Medicine at Stanford University

Terri: Now, you mentioned that one of the concerns with this shift to more of these foreign-made drugs was a quality control issue. And the countries you mentioned—two of the biggest countries where these drugs are made, India and China. What is the scope of the FDA in regulating these drugs manufactured in these countries?

Schulman: Our FDA has the ability to audit US factories. What he needs to do is ask governments for permission to audit factories in India and China. In the United States we have secret inspections. The FDA shows up right at your doorstep and wants to inspect the plant. In India and China, he must ask permission and notify manufacturers that he is coming.

But more broadly… The FDA only inspects every two years. Meanwhile, the FDA has no idea what’s going on at an individual manufacturing plant. I mean, it’s no different than what we’ve seen in other industries that have outsourced. The idea of ​​the FDA monitoring all potential sources of molecules for the US market is really, really hard to imagine.

Terri: Do these countries themselves have organizations equivalent to the FDA? Do they have their own version? And if they do, do they meet the same standards as our FDA?

Schulman: They have nascent institutions that are not at the same level as the United States. I don’t know how big the Chinese FDA was, but a few years ago it was 100 people. The problem here is the supply chain.

You would think that you would test some of these drugs — the suppliers would test or the distributors would test the drugs to make sure that the ones they dispense say what is on the label and that they are of good quality. Unfortunately, what we have seen is that this is not true. And the recalls that happened with these carcinogens in metformin and ranitidine – metformin is a first-line treatment for diabetes, and the FDA eventually recalled 40% of all drugs on the market because of these carcinogens. But the only way we found out about this was actually through a third-party testing organization looking into the issue.

So what’s happening today is that every new manufacturer of a generic drug has to offer a lower price to enter the market. And so prices have dropped, which is a good thing. But again, there is no quality consideration. And so, at a certain point, the market price is lower than the price that a high-quality producer can produce, and people leave the market. And so now we have this market where it’s basically the cheaper manufacturers that are supplying the drugs to the United States.

Terri: What can Americans do now to verify the quality of their generic drugs? Is there anything they can do?

Schulman: Unfortunately, at the moment there is really nothing they can do. But we can go back and say, “We don’t want to tolerate this. If we are paying for a medicine at a pharmacy, we want that pharmacy to assure us that it is a medicine that is made safely and of the highest quality, not the cheapest medicine available that they could find .

Terri: You support a generic drug rating system, similar to the ratings you see on Amazon.com. Even if we had a rating system that assigns, you know, one star, two stars, etc., can you really rate a pill the way you would, say, a vacuum cleaner or a toaster?

Schulman: Absoutely. I mean, there are very specific parameters. Is the dose on the label the actual dose? The quality of the pill, in terms of contaminants, is the quality of the pill there? And then are there other chemicals in the pill that you don’t want in the pill, like those carcinogens that have been found? So I think we can assess it. We can rate it as yes/no. Does it match the label? Is it within the standards? Or we can rate it 1-5. I think it is possible to do one or the other.

It’s really important not to scare off the American public. It is very important to take your medications. But if for a month your high blood pressure pill doesn’t work or you feel really bad when you take your medicine that you’ve been taking for a long time and you wonder if there’s something wrong with the pill, the only thing that I would say that it is quite possible these days that there is something wrong. You can go back to the pharmacy, get another manufacturer, and you can also ask the pharmacy, “Why don’t you give me a quality rating on this drug and a price?” »

Terri: Thank you for taking the time.

Schulman: Thank you very much.

Terri: Dr. Kevin Schulman is a professor of medicine at Stanford University and has extensively studied the changes affecting the generic drug industry.

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Generic drugs

The generic drug market is witnessing the emergence of Amgen Inc. and Dr. Reddys Laboratories Ltd. as major market contributors | 17000 + Technavio


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Analysis of the main players in the market

  • Amgen Inc. – The company offers a wide range of generic drugs like Aimovig, Corlanor, Epogen, Xgeva and others.
  • Dr.Reddys Laboratories Ltd. – The company offers affordable generic formulations such as Omez (Omeprazole), Nise (Nimesulide), Ketorol (Ketorolac Thromethamine) and others
  • Fresenius SE and Co. KGaA – The company offers generic drugs for areas such as anesthesia, maldigestion and oncology

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Generic Drugs Market 2021-2025: Segmentation

The generic drugs market is segmented as follows:

  • Type
    • Small Molecule Generics
    • Biosimilars
  • Geography
    • North America
    • Europe
    • Asia
    • LINE


The generic drug market is driven by increased outsourcing of drug discovery and development and increasing drug patent expirations. Additionally, other factors such as the advent of RPA, increase in mergers and acquisitions, and hospital-owned generics are expected to drive the generic drugs market.

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Generic drugs

Online pharmacies could save Medicare billions on generic drugs

PThe public outcry over the shockingly high cost of brand name drugs and the demand for new laws to limit the cost of these drugs has persisted for years. But more than 90% of all prescriptions – nearly 4 billion a year – are filled with generic drugs.

Little attention has been paid to the fees charged by insurance companies, drug benefit managers, and pharmacies to fill these generic prescriptions. Yet the difference between the highest and lowest price charged for the same generic drug is so great that billions of dollars could be saved each year by having prescriptions filled at the cheapest pharmacies.

The entry of companies like Amazon and GoodRx into the prescription fulfillment business is a game-changer. They offer prices far below what the federal government pays to insurance plans to have these prescriptions filled under Medicare Part D drug coverage. The repeal of the current design of Part D benefits and replacing it with a system in which the government directly reimburses low-cost pharmacies for filling generic prescriptions would save an estimated $18 billion a year. Patients would save an additional $8 billion in co-payments because the prices charged by these pharmacies do not require any form of insurance or additional co-payments.

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I compiled information from the Medicare Part D website on the amount spent per pill for the top 20 selling generic drugs of 2019. I then determined how much Amazon and GoodRx charged for a 90 day prescription for the same 20 medications and calculated the cost per pill for these prescriptions. For example, Medicare paid 26 cents per pill for atorvastatin, the generic version of the cholesterol-lowering drug Lipitor. Amazon fills a 90-day prescription for a 20-milligram atorvastatin tablet, the most common dose, for $4.20. This equates to less than 5 cents per pill. The government paid $919 million to insurance plans to distribute 3.6 billion atorvastatin tablets in 2019. Amazon reportedly distributed these tablets for $182 million, a savings of $737 million on a single drug generic.

As the chart here shows, Medicare spent $8.8 billion to distribute these 20 generic drugs in 2019. Amazon reportedly did this for just $4.6 billion and GoodRx for $5.1 billion. If the prescriptions had been filled by selecting the cheapest drug from Amazon or GoodRx, the cost would have been $3.5 billion. This represents a savings of $5.3 billion (60%) over what Medicare spent.

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In 2019, Medicare Part D filled approximately 1.2 billion generic prescriptions at a total cost of approximately $30 billion. If the 60% savings applied to all generic drugs dispensed under Part D, the government would have saved $18 billion.

In addition to overburdening the government, Part D insurance plans also charge patients co-payments for most generic prescriptions. Iqvia reports that 65% ($8 billion) of the $12 billion in Part D outlays paid by patients are for generic prescriptions. GoodRx estimates that its total price for filling generic prescriptions is less than the Medicare Part D copay about one-third of the time. The Amazon and GoodRx price is the total price of the drug. There is no quota. That means patients would save $8 billion in out-of-pocket costs, bringing the total savings from a Medicare drug benefit overhaul to $26 billion.

How is it possible that the cost of filling generic prescriptions can vary so widely? The answer lies in a lack of transparency on the true cost of generic drugs. The World Health Organization estimates that generic versions of essential medicines can be produced cost-effectively with a 99% reduction in the cost of the brand name medicine. Thus, a patented pill that sells for $1 can be produced profitably and sold as a generic for a penny. In fact, generic manufacturers now sell many of the most widely prescribed generic drugs in the United States for 1 cent to 5 cents per pill.

Competition among generic manufacturers ensures that these pills are offered for sale at a small profit compared to the actual cost of producing them. Yet in a few cases where such competition is lacking, as was the case with the generic version of the EpiPen, the cost of a generic drug may sell for only a small discount to the brand name product.

Insurance plans and drug benefit managers price their generic prescriptions at levels that the market will bear rather than at a reasonable markup over the actual cost of acquiring and dispensing the prescription. Patients and payers think they’re getting a good deal when they get a 70% discount and pay 30 cents per pill for the generic version of a brand name drug they used to pay $1 for. They have no idea that the pharmacy bought this pill for just a penny or two and markup each pill 10 to 20 times its cost. The high markup imposed by insurance plans and drug benefit managers is why the government pays 26 cents a pill for atorvastatin while Amazon sells it for 5 cents.

Discount pharmacies like Amazon disrupt the prescription drug market by pricing their prescriptions on a cost-plus basis while making a fair profit. A 90-day prescription for a generic drug acquired at a cost of 1 cent per pill has an ingredient cost of 90 cents. Average dispensing cost – the cost to the pharmacy for time spent counting and packaging pills, labeling pills, complying with prescription record keeping laws, and recording information required for reimbursement insurance plans – is about $2.40 per prescription. If a discount pharmacy charges $5.00 for this 90-day prescription, they will make a profit of $1.70 on the actual $3.30 cost of the prescription. This equates to a gross profit of 34%, which compares favorably to the reported profit margins of independent pharmacies.

For a 90 day prescription, adding ten cents to the cost of each pill would add $9 to the cost of the prescription. That doesn’t sound like a lot, but doing this for 4 billion prescriptions translates to $36 billion.

Medicare should be able to fill generic prescriptions at the lowest price charged for those prescriptions in the competitive retail market. But the 2003 law that created Part D prohibits the government from seeking the best price and gives private insurance plans exclusive power to set the price. The Republican administration that championed the enactment of Part D mistakenly believed that competition among insurance plans would result in the lowest prices and the widest choices for beneficiaries. No such competition ever materialized. Instead, Part D has created windfall profits for private insurance plans and drug benefit managers while adding unnecessary complexity to the generic prescription filling process. Patients are now faced with an incomprehensible array of forms, quantity limitations and co-payments that often make it cheaper to pay for a generic drug outright than to use Part D insurance.

The current design of the Part D advantage is ill-suited to a world in which discount pharmacies fill prescriptions for generic drugs at affordable prices without insurance. A new design that cuts out costly middlemen and relies on price competition between pharmacies will not only dramatically reduce Part D costs, but will also force all pharmacies to cut their profit margins if they hope to compete for prescriptions of part D, which represent 30% of retail pharmacy activity.

Part D prices for generic drugs would quickly become the benchmark for private payers and drive down prices and copayments for generic drug prescriptions in private insurance plans. The end result would be that more than 90% of all prescriptions could be filled at a lower cost to payers without imposing significant additional costs on patients.

Senate Democrats are currently negotiating a $3.5 trillion soft infrastructure package that will include legislation to reduce patient out-of-pocket payments in Part D and expand Medicare to cover vision, dental and hearing services by mandating new taxes. My proposal to reduce the cost of Medicare for the distribution of generic drugs and the Biden administration’s proposal to limit price increases for brand name drugs could produce enough savings on the cost of current Medicare benefits for drugs on prescription to pay for the proposed expansion of Medicare benefits without these taxes.

Given growing resistance from moderate Democrats to the $3.5 trillion price tag of the proposed infrastructure package, paying for new benefits by reducing the cost of existing ones may be the wisest course.

Alfred Engelberg is a retired intellectual property lawyer and philanthropist who focuses on efforts to make health care and medicine more affordable. As legal counsel to the generic drug industry, he played a major role in drafting the Hatch-Waxman Act of 1984, which created the modern generic drug industry.

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Generic drugs

Consumer perception fuels brand wars and affects use of generic drugs, says CCI chief

New Delhi: According to Ashok Kumar Gupta, Chairman of the Competition Commission of India (CCI), consumer perception of variation in efficacy is driving a brand war in the pharmaceutical retail market, diluting the chilling effect on the prices of drugs sold under their chemical or generic names.

Gupta highlighted the role that generic drugs can play in creating the competitive pressures needed to lower prescription drug prices, reduce health care costs and improve access. However, Indian consumers are ostensibly paying a premium for brands, Gupta said at a CCI-hosted workshop on Friday on competition issues in the pharmaceutical sector. His comments were based on an interim market study conducted by the regulator.

The pharmaceutical market is different from other markets as consumers often do not deviate from the brand prescribed by the doctor or opt for the same drug sold under its chemical name. This distorts competition in the market. Also, drug manufacturers market their products through physicians rather than directly to consumers.

In India, generic drugs promoted by companies under their brand names are called branded generics and those sold under their chemical name are called “generic generics”, although both categories are off-patent drugs.

On this issue of the prevalence of branded generics in the pharmaceutical retail market in India, Gupta highlighted the key role that quality expectations and the perception of efficacy variation between drugs play in fueling brand competition. and dilute the generic price reduction effect in India. India, said an official statement after the workshop. Apart from the quality aspect, he alluded to the important role that Janaushadhi and the emerging private generic retail chains in the country can play in increasing the availability and improving the uptake of generic generics, says the statement quoting Gupta.

Vinod K. Paul, member of NITI Aayog, who spoke on the occasion, said that access to medicines without financial hardship and quality assurance were essential for universal health coverage.

Considering that expenditure on drugs accounts for 70% of out-of-pocket healthcare expenditure in India, he stressed the importance of improving accessibility of drugs, according to the statement.

Paul pointed out that streamlining the commercial margins of 42 cancer drugs on a pilot basis in 2019 led to cost savings of 984 crores for over 500 brands across 42 formulations. Paul further cited instances where margin rationalization resulted in a 90% price reduction on certain drugs, according to the release.

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Generic drugs

Schuyler County joins others in suing generic drug makers for alleged price fixing

WATKINS GLEN, NY (WETM) – Schuyler County has joined more than two dozen city governments, and others, in suing generic drug makers for alleged price-fixing.

The county, along with local governments in New York and elsewhere, filed a 1,000-plus-page subpoena and lawsuit on June 30 against more than 50 businesses, seeking injunctive relief, damages and damages. which, according to the complaint, resulted from an illegal agreement. between the defendants to allocate customers, rig bids and fix, increase, maintain and/or stabilize the prices of all of their generic pharmaceutical products,

The lawsuit follows a vote by the County Legislature in 2020 allowing County Attorney Steven Getman to partner with Napoli Shkolnik PLLC, a New York City law firm “in the investigation and/or the pursuit of any legal claims against generic pharmaceutical manufacturers and/or their officers based on their actions in price fixing, market allocation and participation in other violations of antitrust laws or other wrongdoing regarding generic pharmaceuticals.

According to Getman, the lawsuit pursues claims in several areas. These include increased health insurance premiums for county employees, additional workers’ compensation costs, and higher costs for pharmaceuticals purchased for use by the county jail, all based on artificially inflated generic drug prices.

Various government agencies have already filed a lawsuit, Getman said, alleging violations of state and federal antitrust and consumer protection laws.

“In 2014, the Department of Justice launched an investigation into the prices of various generic drugs,” Getman explained. “As a result of the federal investigation, in 2017, state attorneys general from 48 states filed a civil lawsuit alleging price fixing, market splitting and other antitrust violations by 16 pharmaceutical defendant companies regarding fifteen (15) generic prescription drugs. ”

“As alleged, the defendants’ anti-competitive conduct falls primarily into two categories. First, the defendants communicated with each other to determine and agree on the market share that each would control and the customers to which each competitor was entitled. Second, competitors would have communicated – either in person, over the phone or via text – and agreed to collectively raise and/or maintain prices for a particular generic drug.

The lawsuits, Getman said, now involve more than 100 generic drugs and more than fifty pharmaceutical defendants, including Teva, Sandoz, Mylan, Pfizer, Actavis, Amneal, Apotex, Aurobindo, Breckenridge, Dr. Reddy’s Laboratories, Glenmark, Greenstone, Lannett, Lupin, Par, Taro USA, Upsher-Smith, Wockhardt USA and Zydus.

“As noted, hundreds of generic drugs have been implicated across the country. Each affected county or municipality can file a lawsuit asserting overpayments for each applicable generic drug,” Getman explained. “The key issue in formulating a lawsuit was to determine for which generic drug(s) each county had overpaid, and whether each was the direct or indirect purchaser.”

According to County Administrator Tim O’Hearn, the lawsuit was filed without risk to the county, as Napoli Shkolnik is working on an emergency basis which covers all costs associated with the lawsuit.

“By moving forward with litigation, the County Legislature hopes to ease the burden on taxpayers and seeks to hold manufacturers accountable for any illegal role in the high cost of generic drugs,” O’Hearn said.

Locally, along with Schuyler County, Chemung, Yates and Livingston counties are acting as plaintiffs in the lawsuit. Other municipalities in New York and elsewhere are also part of the deal. The case is currently set to be heard in federal district court for eastern Pennsylvania.

In addition to the generics case, Schuyler County worked with Napoli Shkolnik to pursue an ongoing lawsuit against manufacturers and distributors of prescription opiates for damages to the county resulting from the fraudulent marketing and distribution and negligent opiates in and to the county. . This case remains pending in state court.

A related lawsuit, involving Nassau and Suffolk counties, and the New York State Attorney General’s office, is currently underway on Long Island against several companies accused of fueling the opioid crisis. The lawsuit in Long Island will serve as a test for the claims of Schuyler County and other New York municipalities, as well as an indicator of what could happen to drugmakers, distributors and pharmacies in other states.

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Generic drugs

Does Medicare Exceed Expenses? Costco costs much less for generic drugs | Health info

By Robert Preidt, health day reporter

(Health Day)

WEDNESDAY, July 7, 2021 (HealthDay News) — Can Costco beat Medicare Part D when it comes to prescription drug prices?

Apparently, that’s what a new study claims that found about half of generic drugs were cheaper when purchased from the discount retailer than through the government program.

Researchers compared the prices paid by Medicare Part D plans (including direct patient payments) for 184 generic prescription drugs to the cash prices paid by Costco members for the same prescriptions in 2017 and 2018. More than 45 million Americans are enrolled in Medicare Part D, which covers outpatient prescriptions.

Compared to Costco member prices, Medicare plans topped 13% in 2017 and nearly 21% in 2018, the results showed. Medicare plan participants paid more than Costco members on nearly 53% of 90-day fills in 2018. Of all 30- and 90-day prescription fills, Medicare plans overpaid 43% of the time, researchers found. from the University of Southern California (USC). .

“Our analysis shows that in systems like Costco’s, where incentives are put in place to deliver value directly to the consumer at the pharmacy counter, this is what happens,” the author said. Erin Trish study. She is associate director of the USC Schaeffer Center and assistant professor of pharmaceutical and health economics at USC’s School of Pharmacy.

“It’s time to fix these incentives in the Medicare Part D system to put the patient first,” Trish said in a USC press release.

His team published their findings online July 6 as a research letter in JAMA internal medicine.

Pharmacy benefit managers and other intermediaries negotiate drug prices on behalf of Medicare, but they do not appear to pass all of the savings on negotiated prices to plans and patients, the researchers said.

Generic drugs account for 22% of Part D spending, so policymakers should take a closer look at the practices of these intermediaries, the team suggested.

Study author Geoffrey Joyce is director of health policy at the Schaeffer Center and chair of the department of pharmaceutical and health economics at the USC School of Pharmacy. He said: “Efforts to reduce prescription drug prices tend to focus on brand name drugs, but the opaque pharmaceutical supply system can also lead health plans and taxpayers to overpay for generics.”

And Karen Van Nuys, executive director of the Schaeffer Center’s Life Sciences Value Innovation Program and assistant professor at USC’s School of Public Policy, added, “There’s a lot of price competition among manufacturers of these drugs, but this competition does not benefit the These are not small market drugs where there may be only one supplier who can quote their price. »

SOURCE: University of Southern California, press release, July 6, 2021

Copyright © 2021 Health Day. All rights reserved.

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Generic drugs

Branded or Generic Drugs: Which is Better?

Generic drugs contain the same active ingredient as their brand name counterparts. However, they usually cost much less than the branded version.

Before the Food and Drug Administration (FDA) approves a generic drug, the drug must meet rigorous approval standards. The FDA stipulates that the generic drug must be “pharmaceutically equivalent” to its brand name version.

This ensures that generic drugs have the same purity, strength, stability and quality as branded drugs.

However, not all brand name drugs are available in low cost generic form.

Read on to find out how branded and generic drugs compare in price, appearance, availability, and more.

Generally, generic drugs cost less than their brand name equivalents. The price can be up to 85% lessaccording to the FDA.

There are several reasons for this.

Research costs

Generic drugs benefit from reduced initial research costs.

Brand-name drugs have to go through expensive animal and clinical studies to prove their safety and effectiveness. Generic drugs use the same active ingredients as tested brand name drugs, so they don’t have to perform the same tests. This saves drug producers money, and consumers then benefit from these savings.

Competetion

When more than one company produces a generic version of the same drug, there is more competition. Generally lower prices go hand in hand with more competition.

People are aware of these price differences, and this affects the choice of drugs.

A cross-sectional study of 278 volunteers examined participants’ understanding of generic drugs. The results showed that 88.8% of the volunteers knew that generic drugs are cheaper than branded drugs, and 80.2% said they chose generic drugs because of the lower price.

Appearance

Branded and generic drugs must contain same active ingredient. However, drug characteristics that do not affect safety or efficacy may be different. This includes their appearance.

US trademark laws do not allow generic drugs to look exactly the same as equivalent brand name drugs. However, the magnitude of these differences is regulated.

When a company wishes to obtain authorization to produce a generic drug, it must file an “Abbreviated New Drug Application” or ANDA. These are filed with the FDA Office of Generic Medicines (OGD). Generic drugs may have different physical characteristics than their brand name counterparts.

Significant differences in specifications such as size and color may:

  • negatively affect a person’s compliance with treatment
  • make it difficult for doctors and their patients to identify the drug
  • lead to the placebo effect, where a person believes that a treatment with no therapeutic value is working
  • lead to the nocebo effect, where a person’s negative expectations of a treatment cause it to have a more negative effect on them

AMG has developed a guidance document to help generic drug manufacturers produce drugs similar in shape and size to their brand name counterparts. It provides parameters from a manufacturing and safety perspective.

The FDA requires generic drugs to meet a number of standards before approval. These include:

  • The generic drug is “pharmaceutically equivalent” to the brand name drug.
  • The manufacturer can produce the generic drug correctly and consistently.
  • The generic drug contains the same “active ingredient” as the brand name drug.
  • The correct amount of the active ingredient reaches the target area of ​​the body.
  • The “inactive ingredients” of the generic drug are safe.
  • The vial, box or other container of the generic medicine is suitable.
  • The generic drug label is the same as the brand name drug.
  • The generic drug does not deteriorate over time.
  • Legal exclusivities or patents have expired.

The pharmaceutical company must submit an ANDA, which is an abbreviated New Drug Application. It states that the generic drug meets each standard.

People taking a particular medication may want to know if there is a cheaper generic option. There are several ways to find out if there is a generic version of a brand name drug:

  • Ask the prescribing doctor or pharmacist.
  • Find the drug using the FDA [email protected] system. Look for the brand name drug first.
  • Look up the medicine using the online version of the Orange Book. Look for the brand name drug first.
  • Consult the FDA list of first generic drug approvals. This is where people can find “first generics” – the first time the drug gets FDA approval.

According to AMGall FDA-approved generic drugs must meet the same quality, purity, strength, and stability requirements as their brand name counterparts.

When comparing study health insurance claims in the United States, researchers found that brand name and generic drugs had comparable medical outcomes for chronic physical conditions. The conditions they looked at included hypertension, diabetes, osteoporosis and psychiatric disorders such as anxiety and depression.

However, another analysis found that generic drugs may not have the same clinical impact for cardiovascular disease.

The researchers analyzed reports from the scientific databases MEDLINE and EMBASE. They found that while 60% of the studies reported no difference between the drugs, the risk of hospital visits was higher in people taking the generic.

It is important to note that this study simply showed a correlation. It did not show that the generic drug played a role in increasing hospital visits.

People of lower socioeconomic status tend to have worse health outcomes that others. Also, because they have less disposable income, they may be more likely to choose a generic drug over a brand name drug. One could therefore conclude that some people taking the generic drug in greater numbers are already predisposed to poorer health outcomes.

The study researchers also state that there is not enough evidence to draw firm conclusions.

When determining the best option between brand name drugs and generic drugs, a person’s healthcare professional may consider the specific medical condition and current research when prescribing medications.

In a 2015 report, the American College of Physicians called on doctors to prescribe generic drugs rather than brand name drugs whenever possible.

Learn more about why doctors should prescribe generic drugs.

When choosing which drug to take, a person considers several factors.

Ultimately, it is up to the individual and their healthcare professional to determine the best option from the brand name and generic medications available.

Quality

The pharmaceutical company must submit an ANDA showing that the generic drug meets each standard required by the FDA before the FDA approves it. This includes demonstrating that the generic drug is pharmaceutically equivalent to the brand name drug.

Therefore, people can be sure that the generic drug option is of the same quality as the brand name version.

attitude and intention

Researchers have found that three main categories shape a person’s attitude towards generic drugs and their intention to purchase them. These are:

  • Consumer attitude and behavior: It is a combination of a person’s beliefs and feelings about a product and their behavioral intention towards that product.
  • Consumer Opinions: These include the perspective of a person and their healthcare professional regarding generic medicine.
  • Risks: This includes the risks, if any, associated with the generic drug.

Researchers say that if the pharmaceutical industry, public health policymakers and medical professionals better understand consumer attitudes and behaviors toward generic drugs, they could help expand drug use. generics.

Cost

In 2017, researchers conducted a economic evaluation brand name drug prices. It focused on 49 top-selling drugs that had more than 100,000 pharmacy claims that year.

Of these 49 brand name drugs, 48 ​​showed regular annual or semi-annual cost increases.

Generic drugs cost less than their brand name equivalents. For some people, this cost difference is the deciding factor in whether they are able to take a much-needed medication.

Branded and generic drugs contain the same active ingredients in the same amounts. In most cases, they provide the same therapeutic benefits. Although more research is needed to determine whether brand name drugs are better for certain conditions, the American College of Physicians says doctors should prescribe generics where available.

Because they don’t have to undergo the same human and animal studies as brand-name drugs, FDA-approved generic drugs are significantly less expensive. This price difference influences some people’s decision to choose generic drugs over brand name drugs.

However, it is advisable to discuss brand name and generic drug options with a medical professional. This allows a person to make the right decision based on their health and personal situation.

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Generic drugs

Substandard generic drugs are flooding the US market and putting all Americans at risk

Most Americans would be shocked to learn that millions of doses of low-quality and potentially harmful generic drugs are imported into the United States every year. Despite safety concerns, hospitals continue to use them every day. And supermarket pharmacies, big box stores and corner pharmacies continue to sell it.

Many in Washington will point the finger at the FDA. But the real problem is that American companies are choosing profit over safety by importing and selling substandard generic drugs across the country.

These American companies include large buying groups and wholesalers who follow a very lucrative business model. They simply scour the world for the cheapest generic drugs, often from China and India. For them, the lower the purchase price, the higher the profit margin, regardless of where and how the drugs are produced.

An example is a generic muscle relaxant given to COVID-19 patients on ventilators. At the start of the pandemic, the drug was in short supply. In response, the FDA approved imports from a manufacturer that had received warning letters from the FDA. These drugs must be manufactured under sterile conditions. But the agency warned the company of its failure to prevent contamination of its supposedly sterile drugs.

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These concerns could be avoided if drug buyers put safety over profit and bought generic drugs from reputable manufacturers in the United States. Instead, in their endless quest for cheaper drugs, they choose to ignore safety and quality issues.

This race to the bottom for generic drug prices has driven ethical manufacturers out of business and caused the collapse of the US generic drug manufacturing industry. As a result, the United States now depends on China for thousands of generic drugs, as Beijing controls the supply of basic components for drug manufacturing.

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With the United States now increasingly dependent on imported drugs, doctors, nurses, pharmacists and patients are the first to witness the risks associated with substandard generic imports.

A recent medical journal study reported the life-threatening risks of a generic drug used to treat patients recovering from heart and lung transplants. Researchers found that a generic drug made by two foreign companies did not dissolve properly, hampering its effectiveness and posing life-threatening risks.

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Ordinary drugs don’t meet US standards either. The FDA has warned a maker of a common asthma drug, albuterol, about sterility issues and the risk of contamination from other drugs made at the same facility.

When American companies buy imported drugs at the best possible price, they incur other costs. Patients suffer serious setbacks — blood pressure spikes, failed organ transplant recovery and uncontrolled seizures — when their generic drugs don’t work.

In the worst case scenario, Americans are dying from dangerous drugs purchased by American companies. In 2007 and 2008, for example, hundreds of Americans died from contaminated supplies of Chinese-made heparin.

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In 2018, millions of Americans learned that their blood pressure medications contained a cancer-causing chemical. A Chinese manufacturer, whose product contained the highest amount of the carcinogen, was later banned by the FDA.

It is time to impose a cost on traders of substandard imported drugs. To do this, the United States must once again manufacture these generics at home.

To realistically support U.S. generic drug makers as they compete with cheap imports, Congress should impose “Buy American” requirements on the Department of Defense and the Veterans Administration. Similarly, national procurement policies should also be extended to Medicare and Medicaid.

Americans need safe, quality medicines. Washington must not allow special interests to buy substandard drugs and sell them in the United States. It’s time to bring these vital supply chains home, so that American lives are not at risk.

Rosemary Gibson is chair of the Coalition for a Prosperous America’s Healthcare Committee and author of “China Rx: Exposing the Risks of America’s Reliance on China for Medicine.”

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