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Taking a generic drug is not like buying a store-brand soap. With the soap you might notice a difference. It may smell a bit different. Maybe you need to use more of it per load of dishes or laundry than the brand-name product.
That is not true with generic drugs. Generic drugs are like brand-name drugs.
When drug companies make a brand-name drug, they get a patent for that drug. A patent protects the drug company from other drug companies making and selling the same drug until the patent expires.
Once the patent on a brand-name drug expires, other drug companies are able to make a generic version. 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.
It might sound strange that a company can get permission to copy another company’s product. But while the writers of the Constitution saw the need to protect inventors for a while, patents do not last forever. Patents expire so that good ideas can be shared with more people. And it encourages inventors to come up with even better ideas.
There are eight major parts to the FDA's review of a company's application to make and sell a generic drug:
Check out some common myths about generic drugs, and get the facts that bust those myths:
What Is Bioequivalence?Generics don’t have to repeat the long clinical trials that have already been used to create the original, brand-name drug. These tests usually involve a few hundred to a few thousand patients.
Since the safety and usefulness of the brand-name product has already been proven in research and during many years of patient use, the FDA says that it is not necessary or ethical to repeat testing in human subjects for each generic drug that a company wants to sell.
Instead, companies that want to make generics must show that their product is bioequivalent to the brand drug. That means it is made in the same way with the same ingredients, and it acts the same in the body.
The rules for approving generic copies of drug products were established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. Brand-name drugs are subject to the same tests as generics when their manufacturers change them.
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