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Tag: drug exclusivity

Regulatory Exclusivity: How Non-Patent Protections Delay Generic Drugs
  • Nov, 28 2025
  • Comments 7

Regulatory Exclusivity: How Non-Patent Protections Delay Generic Drugs

Regulatory exclusivity is a government-granted market protection that delays generic drug approval, independent of patents. It gives drugmakers 5 to 12 years of exclusive sales rights and plays a major role in high drug prices.
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