Facts About Generic Drugs

What are generic drugs?

A generic drug is the same as a brand-name drug in:

• dosage
• safety
• strength
• quality
• the way it works
• the way it is taken
• the way it should be used

Are generic drugs as safe as brand-name drugs?

Yes. The FDA says that all drugs must work well and be safe. Generic drugs use the same active ingredients as brand-name drugs and work the same way. So they have the same risks and benefits as the brand-name drugs.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs must be as:

• high quality
• strong
• pure, and
• stable as brand-name drugs

Are brand-name drugs made in better factories than generic drugs?

No. All factories must meet the same high standards. If the factories do not meet certain standards, the FDA won’t allow them to make drugs.

If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. However, the generic drug must have the same active ingredients. Colors, flavors, and certain other parts may be different. But these things don’t affect the way the drug works and they are looked at by FDA.

Does every brand-name drug have a generic drug?

No. When new drugs are first made they have drug patents. Most drug patents are protected for 17 years. The patent protects the company that made the drug first. The patent doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling the generic version of the drug. But, first, they must test the drug and the FDA must approve it.

What is the best source of information about generic drugs?

Contact your doctor, pharmacist or other healthcare worker for information on your generic drugs. For more information, you can also visit the FDA website at:

http://www.fda.gov/cder and click on Consumer Education.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Why are generic drugs less expensive?

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. But they must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA. Your medication guide should be kept with you and up to date. List your prescription and over-the-counter medicines as well as your dietary supplements.

Your medication guide should be kept with you and up to date. List your prescription and over-the-counter medicines as well as your dietary supplements.

Generic Drugs:

Safe. Effective. FDA Approved.

U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Food and Drug Administration

1-888-INFO-FDA - www.fda.gov

Source: FDA Consumer Update. http://www.fda.gov/cder/consumerinfo/generic_FactsAbout_text.htm

Date Created November 16, 2004.
Updated August 7, 2006