Tag: patent term restoration

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

Barbara Lalicki December 6, 2025 Pharmacy 3 Comments
Hatch-Waxman Amendments: How Landmark Law Made Generic Drugs Possible

The Hatch-Waxman Act of 1984 created the modern system for generic drugs in the U.S., cutting approval costs and speeding access. It balanced brand-name patent protection with generic competition, leading to 90% of prescriptions now being filled with generics.

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