Tag: Hatch-Waxman Act
ANDA Process: Legal Requirements for Generic Drug Approval in the U.S.
- By : Tamsin Riverton
- Date : Jan 26 2026
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 active ingredients, and strict manufacturing standards to ensure safety and affordability.
Why Brand Companies Launch Authorized Generics: Strategy Explained
- By : Tamsin Riverton
- Date : Dec 19 2025
Brand companies launch authorized generics to protect revenue, block generic monopolies, and keep customer trust. These are the exact same drugs, sold cheaper - and they're reshaping how pharmaceutical markets work.
