Have Questions about Generic Drugs?
Generic drugs provide cost-effective treatments for people who need them. Here are some of the most common questions people have about generic medications.
- What are generic drugs?
- Are generic drugs safe?
- Are generic drugs as effective as brand name drugs?
- Are generic drugs made with the same quality and standards as brand-name medications?
- Does every brand name drug have a generic counterpart?
- Why do they cost less than brand name drugs that do the same thing?
- What is the law that governs the creation of generic drugs?
What are generic drugs?
Generic drugs are drugs that are essentially copies of the active ingredients in brand name drugs. Generic drugs are chemically identical to their brand name counterparts (and so are the same in effect, quality, performance, and use), but typically cost less.
Are generic drugs safe?
Generic drugs are just as safe and effective as brand name drugs - and are also FDA approved.
Are generic drugs as effective as brand name drugs?
Yes. The active ingredient is the same substance.
Are generic drugs made with the same quality and standards as brand name medications?
Yes. The Food and Drug Administration (FDA) monitors the development of both brand name and generic drugs. Before generic medications can be sold in the United States, the FDA requires medications to meet specifications for identity, strength, quality, purity and potency.
Does every brand-name drug have a generic counterpart?
No, but an increasing number do. Because patent protection laws prevent generic versions for 20 years from the patent date, only after 20 years can generic forms be created and sold. The FDA Generic Initiative for Value and Efficiency, put in place in 2007, has streamlined the process of generic drug approval, and made it more likely that drugs will have a generic alternative.
Why do they cost less than brand name drugs that do the same thing?
Most new drugs are patent protected by law, and can be sold only by the company that developed them for 20 years. This allows companies who develop new drugs to recoup the costs of developing new drugs, which is a complex, lengthy and expensive process. But after 20 years the patent expires and generic versions of the same drugs may be made. Since generic drug companies don't have the same research costs, they sell the drug for substantially less than the brand name drug cost, saving consumers money.
What is the law that governs the creation of generic drugs?
The Drug Price Competition and Patent Term Restoration Act of 1984 is the law that permits the creation of generic drugs and protects the drug developer for a period initially as well. The same law also allows drug sponsors of identical products to apply for FDA approval without repeating the original developer's clinical trials - and in fact encourages generic firms to create generic drugs by awarding exclusive marketing rights to the first generic version challenger.
For more information about generic medications, ask your physician or pharmacist.
Or visit the FDA Web site at www.fda.gov/cder/ogd.
FDA Contact
US Office of Generic Drugs
http://www.fda.gov/aboutfda/centersoffices/cder/ucm119100.htm
FDA Database of Approved Products
