Facts About Generic Drugs

What is a generic drug?

A generic drug is a drug that is exactly the same as the brand-name drug, but can only be produced after the brand-name drug's patent has expired.

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

A drug company develops new drugs as brand-name drugs under patent protection. This in turn protects the investment in the drug's development by giving the drug company the sole right to manufacture and sell the brand-name drug while the patent is in effect.

When patents or other periods of exclusivity expire, other manufacturers can submit an abbreviated new drug application (ANDA) to the FDA for approval to market a generic version of the brand-name drug.

Although generic drugs are chemically identical to their branded counterparts, they are typically sold at a cheaper price than the brand-name drug because the drug has not been developed from scratch, and the costs to bring the drug to market are less.

Are generic drugs as safe as brand-name drugs?

Yes. The FDA must first approve all generic drugs. The FDA requires that generic drugs must be as high in quality, and as strong, pure and stable as brand-name drugs. Generic drugs use the same active ingredients as brand-name drugs and work the same way. They have the same risks and the same benefits as the brand-name 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 the effectiveness of the drug remains the same.

Does every brand-name drug have a generic drug?

No. New drugs are developed under patent protection, and most drug patents are protected for 17 years giving the drug company the sole right to sell the brand-name drug during that time. Only when the patent expires can other drug companies apply to the FDA for approval to start selling the generic version of the drug.

You can search for generic equivalents by using the "Electronic Orange Book" at http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm and search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers.

Since there is a lag time after generic products are approved and they appear in the "Orange Book," you should also consult the most recent monthly approvals at "First-Time Generic Drug Approvals".

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/Drugs/default.htm and click on Consumer.

Sources:
Facts About Generic Drugs US FDA Center for Drug Evaluation and Research
What are Generic Drugs? Office of Generic Drugs, US FDA Center for Drug Evaluation and Research

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