According to the FDA, 9 out of 10 prescriptions filled in the U.S. are for generic drugs. The FDA’s Office of Generic Drugs (OGD), falling under the umbrella of the Center for Drug Evaluation and Research, is in charge of the generic drug regulatory process. Generic drugs must contain the same active/key ingredient, have the same strength, and use the same dosage form and the same route of administration as their brand name product. Generic drugs may have minor differences from the brand such as different inactive ingredients. All of these measures also ensure that generic drug treatments are more affordable to patients.
Abbreviated New Drug Application (ANDA)
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments, allows the FDA to approve generic drugs through the ANDA. Generic drug applications do not need to include clinical trials to demonstrate safety and efficacy. Instead, the Hatch-Waxman Amendments established that the generic product must be bioequivalent to the brand product through examination of the drugs in healthy volunteers. All approved products are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The first generic drug company to submit their ANDA with a provision challenging a patent receives a180-day generic drug exclusivity. This means it’s the only generic product on the market without competition by another company. After the 180-day exclusivity period finishes, other generic products can enter the market and the drug prices decrease.
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