Tag: Hatch-Waxman Act
Mar, 23 2026
Predicting Generic Entry: Forecasting When Your Drug Gets Generics
Predicting when a drug will lose patent protection and face generic competition requires more than just checking expiration dates. It involves tracking lawsuits, FDA approvals, evergreening tactics, and market dynamics that can delay entry by years.
Jan, 7 2026
Hatch-Waxman Act: How It Shaped Generic Drug Access in the U.S.
The Hatch-Waxman Act created the modern system for generic drug approval in the U.S., balancing innovation incentives with affordable access. It slashed drug costs by 80%+ and now drives 90% of prescriptions.