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Tag: ANDA

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

Hatch-Waxman Amendments generic drugs FDA approval ANDA patent term restoration
Caspian Sterling
4.12.2025

The Hatch-Waxman Amendments of 1984 created the modern generic drug industry by letting companies approve cheaper versions of brand-name drugs without repeating clinical trials. It balanced innovation incentives with faster access to affordable medicines.

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