Tag: patent term restoration
Hatch-Waxman Act: How It Shaped Generic Drug Approval in the U.S.
Dec, 16 2025
The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with faster market entry. It slashed drug costs, boosted generic use to 90% of prescriptions, but also enabled patent abuses that delay competition.