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Tag: FDA orphan designation

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

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

Orphan drug exclusivity gives pharmaceutical companies seven years of market protection for rare-disease treatments, encouraging development where profits were once impossible. Since 1983, over 1,000 such drugs have reached patients - but debates over pricing and abuse continue.

1 Feb 2026

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