Tag: Hatch-Waxman Act
How Brand Manufacturers Produce Their Own Generic Versions
Brand manufacturers produce their own generic versions-called authorized generics-to keep market share after patents expire. These are identical to the original drug but sold under a different label. Learn how they work, why they’re priced the way they are, and what it means for patients.
ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.
The ANDA process is the legal pathway for generic drug approval in the U.S., requiring bioequivalence, identical active ingredients, and strict manufacturing standards under the Hatch-Waxman Act. Learn the key requirements, costs, and pitfalls.
