Tag: 180-day exclusivity

180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Market
January 12, 2026
180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Market

The 180-day exclusivity rule for generic drugs was meant to reward patent challengers-but authorized generics let brand-name companies undercut them. Here's how the law works, why it's broken, and what’s being done to fix it.

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First-Mover Advantage: How Generic Drug Manufacturers Win Big by Launching First
December 18, 2025
First-Mover Advantage: How Generic Drug Manufacturers Win Big by Launching First

The first generic manufacturer to launch after a patent expires captures up to 90% of the market and retains a dominant share for years due to prescriber habits, pharmacy stocking rules, and patient loyalty-thanks to the Hatch-Waxman Act's 180-day exclusivity.

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