Off Patent
May 2026

Kuvan

sapropterin dihydrochloride

Biomarin Pharmaceutical Inc

Tablet (oral) · NDA 022181

Last listed protection ended
May 16, 2026

The FDA listed 9 patents for Kuvan, and this is the day the last one ended. It is not the date a generic goes on sale.

Patents and exclusivities

  1. Ended
    Patent 7,566,714
    Claims a use (U-989)
  2. Ended
    Patent 7,612,073
    Claims a use (U-1010)
  3. Ended
    Patent 7,727,987
    Claims the drug product
  4. Ended
    Patent 8,067,416
    Claims a use (U-989)
  5. Ended
    Patent 8,318,745
    Claims the drug product
  6. Ended
    Patent 9,433,624
    Claims a use (U-1589)
  7. Ended
    Patent RE43797
    Claims a use (U-1156)
  8. Ended
    Patent 7,566,714
    Pediatric extension: six more months
  9. Ended
    Patent 7,612,073
    Pediatric extension: six more months
  10. Ended
    Patent 7,727,987
    Pediatric extension: six more months
  11. Ended
    Patent 8,067,416
    Pediatric extension: six more months
  12. Ended
    Patent 8,318,745
    Pediatric extension: six more months
  13. Ended
    Patent 9,433,624
    Pediatric extension: six more months
  14. Ended
    Patent RE43797
    Pediatric extension: six more months
  15. Ended
    Patent 7,566,462
    Claims the drug product
  16. Ended
    Patent 8,003,126
    No claim type listed
  17. Ended
    Patent 7,566,462
    Pediatric extension: six more months
  18. Ended
    Patent 8,003,126
    Pediatric extension: six more months