Tag: FDA exclusivity

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

Brittany Thayer 21 January 2026 2

The 180-day exclusivity rule under the Hatch-Waxman Act rewards the first generic drug company to challenge a patent-but often delays market entry for years, keeping prices high. Here's how it works and why it matters for patients and drug access.

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