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When companies make a brand-name drug, they get a patent. A patent stops other drug companies from making and selling the same drug before the patent runs out. When the patent on a brand-name drug expires, other drug companies can make a generic version. Generic versions can be equivalents or authorized generics, which are exact copies of the original brand name drug, or generic alternatives. Generic alternative drugs treat the same condition but do not have the same ingredients.
After getting approval from the U.S. Food and Drug Administration (FDA), the generic drug is made and sold under the active ingredient’s name.
Generics don’t have to repeat the long clinical studies used to make the brand-name drug. The safety and value of the brand-name product has already been proven with research and many years of patient use.
Instead, companies that want to make a generic must show the FDA that it is a “bioequivalent” to the brand drug. That means:
The FDA considers several factors before it allows a company to make and sell a generic equivalent drug.
Now that you know the care and safety that goes into making generic drugs, you can take yours with peace of mind.
Originally published 5/11/2016; Revised 2021, 2023
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