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Tag: generic drug exclusivity

FDA's 180-Day Exclusivity: How First Generic Applicants Gain Market Advantage
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FDA's 180-Day Exclusivity: How First Generic Applicants Gain Market Advantage

  • 31 January, 2026
  • by Juliet Hargrove

The FDA's 180-day exclusivity gives the first generic drug applicant a temporary monopoly to encourage patent challenges. But delays and loopholes often block competition, raising drug costs. Here's how it really works - and why reform is coming.

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