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

Joan J. Dean

The author Joan J. Dean