Tag: ANDA pathway

Hatch-Waxman Act: How U.S. Law Made Generic Drugs Fast, Affordable, and Legal

The Hatch-Waxman Act created the legal framework that made generic drugs fast, safe, and affordable in the U.S. By allowing abbreviated approvals and patent challenges, it saved over $1.7 trillion in healthcare costs and now drives over 90% of prescriptions.

  • Dec, 24 2025
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