small molecule

KUVAN

SAPROPTERIN DIHYDROCHLORIDE

Loss of exclusivityMay 2033latest FDA-listed patent expiry
CompanyBiomarin PharmaceuticalSee this company's full patent-cliff portfolio

Drug detail

Brand nameKUVAN
Active ingredientSAPROPTERIN DIHYDROCHLORIDE
Strength500MG/PACKET
Dosage formFOR SOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalOctober 2015
Marketing statusRX

Listed patents

PatentExpiresType
9216178*PEDMay 2033
9216178November 2032product

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

KUVAN patent cliff — loss of exclusivity May 2033 | CliffBio