Tag: Hatch-Waxman Act

  • Jul, 5 2026
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Market Exclusivity Extensions: Mechanisms Beyond Patents

Explore how pharmaceutical companies extend market dominance beyond patent expiration using regulatory exclusivities, PTEs, and evergreening strategies in the US and EU.

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  • Mar, 8 2026
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Paragraph IV Patent Challenges: How Generic Drug Makers Beat Brand Patents

Paragraph IV patent challenges let generic drug makers legally fight brand patents to bring cheaper drugs to market. Under the Hatch-Waxman Act, the first challenger gets 180 days of exclusivity-making it a high-stakes game of law, money, and patient access.

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