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.

Kaleb Gookins
10 Dec 2025

The Hatch-Waxman Act revolutionized U.S. generic drug approval by balancing innovation and competition. It cut costs, sped up access, but also opened doors to patent abuse. Here’s how it works-and why it’s under pressure.