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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.

  • 22.01.2026
  • Elliot Kelly
  • 14 Comments

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with faster market access. It saved billions and now faces new challenges from patent abuse.

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