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Tag: FDA exclusivity

180-Day Exclusivity in Generic Drug Market Entry: How Patent Law Shapes Drug Prices 7 Jan 2026
  • By Paul Gray
  • 2 comment
180-Day Exclusivity in Generic Drug Market Entry: How Patent Law Shapes Drug Prices

180-day exclusivity under the Hatch-Waxman Act gives the first generic drug challenger a temporary monopoly to incentivize patent challenges. But delays in market entry can block competition for years, keeping prices high for patients.

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