|
|
|
|
|
What is a Generic Drug?
A generic drug is an exact replica of a brand-name drug in dosage-form, safety, strength, delivery method, quality, performance, and intended use. It contains the same active ingredients (although the inactive ingredients may vary), and must meet the same FDA-required standards as the brand-name drug.
Who Makes Generic Drugs?
About half of generic drugs are produced by brand-name firms, with the remainder produced by companies that specialize in generic drugs. Generic drug manufacturing facilities are just as modern and safe as those that produce brand-name drugs. Prior to generic drug production, all companies are required to submit an application to the FDA called an "abbreviated new drug application" (ANDA). However, there is no need to repeat the same costly animal and clinical studies that were already
|
|
|
|
|
|
|
|
|
|
|
performed on the chemicals.
If Brand-Name Drugs and Generic Drugs Have the Same Active Ingredients, Why Do They Look Different?
Trademark laws in the United States do not allow generic drugs to look exactly the same as their brand-name counterparts. The active ingredients and the way they work must be identical, but they are allowed to change the colors, flavors, and other inactive parts.
Why Are Generic Drugs Less Expensive?
It is very expensive to research, develop, test, market, and promote a new drug. Generic manufacturers do not have the same costs as the developer, thus they can sell the drugs at a substantial discount. Patent protection helps protect the brand-name company's investment in the new drug. While a patent is in effect, the
|
|
|
|
|
|
|
|
|
|
|
brand-name company has the exclusive right to sell their drug. This helps replenish the money that they spent to research and develop this drug as well as fund research to create new drugs.
Where Can I Learn More about Generic Drugs?
Ask your physician, pharmacist, or insurance company about generic drugs you are taking or would like to try. You can also visit the FDA website at www.fda.gov/cder/ogd/index.htm for more information.
|
|
|
|
|
|
