The ANDA process is the legal pathway for generic drug approval in the U.S., governed by the Hatch-Waxman Act. It requires bioequivalence, identical formulation, and strict manufacturing standards to ensure safe, affordable alternatives to brand-name drugs.
The 180-day exclusivity rule under the Hatch-Waxman Act gives the first generic drug maker to challenge a patent a temporary monopoly. This law shapes drug prices, delays competition, and impacts patient access to affordable medications.