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Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity
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Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

  • Gareth Wycliffe
  • Dec 10, 2025

The first generic drug filer gets 180 days of exclusive market rights under the Hatch-Waxman Act. This rule was meant to lower drug prices-but loopholes let companies delay competition. Here’s how it works, who benefits, and why reform is overdue.

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