Tag: Hatch-Waxman Act

180-day exclusivity Hatch-Waxman Act generic drug market patent challenge ANDA

180-Day Exclusivity in Generic Drug Market Entry: How Patent Challenges Shape Drug Prices

The 180-day exclusivity rule lets the first generic drug company to challenge a patent block competitors for six months. But delays, settlements, and loopholes often prevent patients from getting affordable meds-despite the law’s original intent.

January 15 2026

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