Tag: Hatch-Waxman Act

first generic approval FDA generic Hatch-Waxman Act generic drug exclusivity generic drug pricing

First Generic Approval: Why It Matters and What It Means for Drug Prices and Access

First generic approval by the FDA triggers massive price drops and wider access to medications. Learn how the 180-day exclusivity window works, why it matters for patients, and how it reshapes the drug market.

December 26 2025