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180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets 21 Dec 2025
  • By Paul Gray
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180-Day Exclusivity and Authorized Generics: Legal Considerations in U.S. Drug Markets

The 180-day exclusivity rule was meant to reward generic drug companies that challenge patents. But brand-name companies can launch their own versions - authorized generics - during that time, undercutting the reward and slowing real competition.

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