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Tag: FDA 180-day exclusivity

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

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

FDA's 180-day exclusivity gives the first generic drug applicant a legal monopoly to delay competition-sometimes for years. Learn how it works, who benefits, and why reform is on the horizon.

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Feb 7, 2026 by Sara Hooshyar

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