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Home About Generics FAQs

Frequently Asked Questions

For Consumers | For Analysts/Researchers

What is a generic medicine?
When a medicine is first developed, the pharmaceutical company discovering the product and bringing it to the market for the first time is granted a period of patent protection on that medicine. When the patent expires, typically after 20 years, other pharmaceutical companies can then seek approval from the U.S. Food and Drug Administration (FDA) to market an equivalent product under its chemical, or "generic," name. Sometimes generic versions of patented products may enter the market before the expiration of a patent if that patent is shown to be invalid or if the generic version does not infringe on the patent.

The FDA requires that the generic pharmaceutical manufacturer must prove that their generic version of the product:

• contains the same active ingredient;
• is identical in strength, dosage form and route of administration;
• has the same indications, dosing and labeling;
• is bioequivalent;
• meets the same batch-to-batch requirements for strength, purity and quality; and,
• is manufactured under the same strict good manufacturing practice regulations as the branded pharmaceutical.

Is a generic drug available for my brand name prescription?
The easiest way to learn whether a generic is available is simply by asking your doctor or pharmacist.

There are also online resources, such as the FDA’s Electronic Orange Book. To use the Orange Book, first search by proprietary "brand name," then search again by using the active ingredient name. The generic drug manufacturers are listed beside the "brand name" manufacturer when searching by the "active ingredient."

Most pharmacy Web sites have tools that enable consumers to compare prices of prescription medicines. Search first for the brand, and if the generic is available, it should appear in your search results.

Why are generic drugs sometimes a different color or shape than the brand version and does this matter?
Sometimes the generic manufacturer may be prohibited from adopting the same color or shape because of patents protecting the brand drug. These cosmetic differences in no way impact the safety or effectiveness of the generic version.

I’ve heard that to save money, generic companies can manufacture their versions of drugs to less rigorous standards than those to which the brand companies must adhere. Is this true?
Absolutely not. The FDA requires all manufacturers and their facilities to adhere to specific guidelines, called Good Manufacturing Practices, no matter what the drug and no matter who the manufacturer. It must contain the identical amount of the active ingredient and work the same way in order to gain FDA approval. In addition, the FDA scientists, chemists and microbiologists reviewing generic medicines have the same qualifications as those reviewing the brand drugs.

Are the non-active ("inert") ingredients in generic medicines as good as those in brand name drugs?
Everything that goes into a medicine must be approved by the FDA, including the inert ingredients. Sometimes a generic manufacturer must change one or more of these because the brand company has patented the formulation of the specific drug. These changes in no way affect the effectiveness of the drug, since the generic manufacturer must show the FDA that the active ingredient still gets into your body to the same extent and rate as the brand name.

The FDA also has information on its Web site about the ingredients in generic medicines.

Where can I compare prices of medicines?
Many pharmacies enable consumers to conduct price comparisons online. [Most pharmacy Web sites can be accessed by typing into your Web browser the pharmacy’s name and adding .com at the end.]

Later this year, the Medicare program is expected to launch an online price calculator for program beneficiaries.