Tag: patent term restoration

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.

Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with affordable access. It cut drug costs by billions but also opened the door to patent abuse and legal delays.

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