Tag: generic drug approval

Hatch-Waxman Act: How Federal Law Shapes Generic Drug Approval in the U.S.

Posted by Desmond Carrington on 4/12/25

The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation with affordability. It cut approval costs, enabled 90% generic market share, and saved over $1.7 trillion-but patent games still delay access.