February 2021

Generic drugs

Are generic drugs as safe and effective as brand name drugs?

This article on generic drugs is based on information from the United States Food and Drug Administration.

Whether or not you have prescription drug coverage, if you use generic drugs when it suits your condition, you can save money — often 80-85% less than the prescription drug. brand. But, are generic drugs safe? According to the United States Food and Drug Administration (FDA), generic drugs are as safe and effective as their brand name counterparts.

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What is a brand name drug?

A brand name drug can only be produced and sold by the company that holds the patent for the drug. Brand name drugs may be available by prescription or over the counter. For example:

  • Tenapanor, a drug used to treat irritable bowel syndrome with constipation, is sold by prescription only by Ardelyx under the brand name Ibsrela.
  • Oxybutynin, a drug used to treat an overactive bladder, is sold without a prescription by Allergan under the brand name Oxytrol.

What are generic drugs?

When a brand name drug’s patent expires, a generic version of the drug can be produced and sold. A generic version of a drug must use the same active ingredient(s) as the brand name drug and must meet the same quality and safety standards. Additionally, the FDA requires that a generic drug be identical to a brand name drug in:

  • dosage
  • security
  • strength
  • the way it works
  • the way it’s taken
  • how it should be used
  • the health conditions it treats

All generic drugs must be reviewed and approved by the US Food and Drug Administration (FDA) before they can be prescribed or sold over the counter.

Are generic drugs as safe and effective?

According to the FDA, all drugs, including brand name drugs and generic drugs, must work well and be safe. Generic drugs use the same active ingredients as their brand name counterparts and therefore have the same risks and benefits.

Many people worry about the quality of generic drugs. To ensure quality, safety, and efficacy, the FDA subjects all generic drugs to a thorough review process that includes a review of scientific information about the ingredients and performance of the generic drug. Additionally, the FDA requires that a generic drug manufacturing plant meet the same high standards as a brand name drug manufacturing plant. To ensure compliance with this rule, the FDA conducts approximately 3,500 on-site inspections each year.

About half of all generic drugs are made by brand name companies. They can make copies of their own drugs or brand name drugs from another company and then sell them without the brand name.

Why is it different?

Generic drugs are not allowed to look exactly like any other drugs sold due to US trademark laws. Although the generic drug should contain the same active ingredient as the brand name drug, the color, flavor, additional inactive ingredients, and form of the drug may be different.

Does every brand name drug have a generic drug?

Brand name drugs generally have patent protection for 20 years from the date the patent application was filed in the United States. This protects the pharmaceutical company that paid for the research, development and marketing expenses of the new drug. The patent does not allow any other company to manufacture and sell the drug. However, when the patent expires, other pharmaceutical companies, once approved by the FDA, can start manufacturing and selling the generic version of the drug.

Due to the patenting process, drugs that have been on the market for less than 20 years do not have a generic equivalent sold. However, your health care provider may prescribe a similar drug to treat your condition that has a generic equivalent available.

Why are generic drugs cheaper?

It takes more than 12 years to bring a new drug to market. It costs an average of $650 million. Since generic drug companies do not have to develop a drug from scratch, it costs much less to bring the drug to market.

Once a generic drug is approved, several companies can produce and sell the drug. This competition drives prices down. Additionally, many generic drugs are well-established, frequently used drugs that do not have to bear the costs of advertising. Generic drugs can cost between 30% and 95% less than brand name drugs, depending on generic competition.

Health care provider preferences

Despite the fact that the active ingredient in a generic drug is the same as its brand name counterpart, small differences could affect how the generic drug works in your body. This may be due to the way the generic drug is produced or the type and amount of inactive materials present in the drug. For some people, these slight differences may make the medicine less effective or cause side effects.

An example of the generic versus brand name drug controversy is the drug levothyroxine, used to treat people with hypothyroidism (hypothyroidism). Since many people with low thyroid are sensitive to very small changes in the dose of their medications, switching between branded and generic versions of levothyroxine can cause symptoms of too little thyroid medication or side effects from too much medicine.

Before switching to a generic drug, talk to your health care provider and make sure you’re both comfortable with the change.

FDA Resources

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Generic drugs

The size of the generic drug market is worth approximately US$675.2 billion per

OTTAWA, Feb. 10 2021 (GLOBE NEWSWIRE) — The world generic drug market is expected to grow at a compound annual growth rate (CAGR) of 5.7% over the forecast period 2021 to 2030 and was valued at USD 387.92 billion in 2020.

Why generic drugs?

Generic drugs refer to drugs that are chemically similar to an existing brand name drug. These drugs are inexpensive and similar to brand name drugs in terms of potency, route of administration, consistency, effectiveness, and usage. These are subject to administrative regulations in different countries, rather than associated with a particular company. These drugs have proven to be as safe and effective as their brand name formulation, which has already been marketed. While other characteristics, such as color, shape and aroma that do not influence the health and efficacy of pharmaceutical products that differ from the original edition; generic versions are formulated with the same active ingredients as their advertised counterparts when working the same way and in quantity at the time.

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Growth factors:

The low price of generic drugs as a substitute for branded drugs is the supreme crucial factor in the growth of the global generic drugs market. Generic drug manufacturers do not have to face high drug improvement costs and therefore the cost is 85% lower than brand name drugs. Research and development costs, as well as drug discovery, are not included in the case of generic drugs. A very small amount needs to be invested in pre-market data collection of generic drugs. The companies rely on clinical evidence provided by the innovators’ company for the health and effectiveness of the drug. Additionally, generic drug applicants do not need to repeat the animal and clinical (human) studies necessary to demonstrate the safety and effectiveness of branded drugs. As a result, generic drugs, with similar active ingredients having the same strength, stability, purity, efficacy, and protection as brand name drugs, are available at a lower price than brand name drugs. Such benefits lead patients to opt for generics as alternatives to expensive brand name drugs. Another major factor that is expected to boost the growth of the target market in the near future is the increase in the number of branded drugs whose patent has expired. Drug prices drop dramatically when patents expire. The degree of price reduction varied greatly between products and nations. The increasing prevalence of chronic diseases, diabetes and cardiovascular diseases creates a huge demand for these drugs. However, the number of brand-name drugs whose patent has expired is constantly increasing in the North America region, which offers huge potential opportunities for the generic drug industry, as generic drugs offer various advantages over non-generic drugs. For example, in 2019, the FDA approved approximately 108 generic patents in the United States alone.

Report Highlights:

  • On the basis of drug type, single generic drugs segment is expected to hold the largest revenue share during the forecast period 2021-2030. This growth is mainly attributed to the low cost associated with generic drugs compared to super generic drugs. Other supergenerics in the drug-type segment are expected to withstand a remarkable growth rate over the forecast period.
  • Based on therapeutic application, oncology therapeutic applications segment accounted for the largest revenue with a large share in 2020. This is attributed to the growing demand for the treatment of oncology disorders globally. The cardiovascular segment is expected to grow at a reasonable CAGR during the forecast period.
  • Teva Pharmaceutical Industries Ltd. leading player in the global industry esteemed for remarkable global market share. The growth is accredited by the different business strategies adopted by the company.

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Regional analysis:

The report covers data for North America, Europe, Asia-Pacific, Latin America, Middle East and Africa. In 2020, North America conquered the global market with a market share of over 30%. The United States was the country with the most shares in the North America region, mainly due to the advanced healthcare infrastructure, the growing prevalence of chronic diseases and the presence of layers of head in North American countries. The generic drug industry market in Asia Pacific is estimated to witness remarkable growth over the next 10 years. The Chinese generic drug industry market is expected to dominate in terms of revenue in the Asia-Pacific region. The increase in the prevalence of chronic diseases among the population as well as the increase in the initiatives of regulatory bodies to control them in the countries of the region is one of the main drivers for the growth of APAC. Nevertheless, emerging markets in the AAC region are creating growth opportunities in the target market.

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Key Market Players and Strategies:

The main companies operating in the world of generic drugs are 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 among others. Investment in research and development of generic drugs along with strategic collaborations are the crucial business strategies undertaken by major players operating in the generic drugs market.

Market segmentation

  • Type of drug: Simple generics and super generics
  • By brand: Pure Generic Drugs and Branded Generic Drugs
  • By route of drug administration: Oral, topical, parental and others
  • By therapeutic application: Central nervous system (CNS), Cardiovascular, Dermatology, Oncology, Respiratory and Others
  • By distribution channel: Hospital Pharmacies, Retail Pharmacies, and Others
  • By regions: North America, Europe, Asia-Pacific, Latin America, Middle East and Africa (MEA)

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