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Generic Drugs

A generic drug is a copy of a brand name drug. It works the same as the brand name drug.

Are generic drugs safe? Yes

• The FDA requires that all drugs are safe and effective. Generic drugs use the same substances and work the same way in the body as brand name drugs. So they have the same risks and benefits as the brand name drug.

Are they as strong as brand name drugs? Yes

• The FDA demands that generic drugs are just as strong, pure, and stable as brand name drugs. They must also be the same quality.

Will they take longer to work in my body? No

• Generics work in the same way and in the same amount of time as brand name drugs.

Why are they cheaper?

• New drugs are developed under patents. A patent gives only that one company the right to sell the drug for a period of time. This protects those who create the drug and pay to research, develop, and market it.
• Other companies can apply to the FDA to sell a generic when the patent is about to expire. Generic companies do not have the same up-front costs to research and develop the drug. They can sell their drug at a lower cost, because their makers don't have the costs of creating the new drug.
• Also, once generic drugs are approved, there are more people trying to sell the drug. This keeps the price down.
• Today, almost half of all prescriptions are filled with generic drugs.

Are brand-name drugs made in better factories? No

• Both brand name and generic drug factories must meet the same standards. The FDA will not let drugs be made in poor quality factories. The FDA inspects about 3,500 factories a year to make sure they meet the standards. Often the same factories make both brand-name and generic drugs.

Why don't the drugs look the same?

• In the United States, laws do not allow a generic drug to look exactly like the brand name drug. A generic drug must use the same substances as brand drugs. Colors, flavors, and some other inactive parts may be different.

Does every brand name drug have a generic form? No

• Brand name drugs are protected by patent for 20 years. When the patent expires, other drug companies can create generics. But they must be tested by the maker and approved by the FDA.

What is the best source of information about generic drugs?

• Contact your doctor, pharmacist, or insurance company for information on generic drugs.

August 2005

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FDA Office of Women's Health