Orphan Drug Designations

FDA gives drugs for rare diseases (fewer than 200,000 US patients) an orphan designation, with tax credits and seven years of market exclusivity once approved. This is every designation since 1983 and when each exclusivity ends.

8,288 orphan designations FDA has granted since 1983, 1,468 of which reached an approval for the designated use, current to Nov 13, 2026. A designation earns tax credits and fee waivers; an approval earns seven years of orphan exclusivity.

• Designated in the last 12 months: 376
• Orphan approvals, last 12 months: 96
• Median designation to approval, last 5 years: 6.7 years
• Exclusivities ending in 2 years: 156