Generic Drugs
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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 be safe and effective. Generics 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 be 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 name 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.
To learn more:
FDA Center for Drug Evaluation and Research
www.fda.gov/cder/ogd/index.htm
FDA Office of Women's Health
www.fda.gov/womens/
2007