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Tag: FDA orphan designation

Orphan Drug Exclusivity: How Rare-Disease Medicines Get Market Protection

Orphan Drug Exclusivity: How Rare-Disease Medicines Get Market Protection

  • by Geoff Bahre
  • 15 December 2025
  • 1

Orphan drug exclusivity gives pharmaceutical companies seven years of market protection for rare-disease treatments, encouraging development of drugs that would otherwise be too costly to produce. Here's how it works, who benefits, and why it's changing.

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