CliffBio
small molecule

KUVAN

SAPROPTERIN DIHYDROCHLORIDE

Loss of exclusivityMay 2026latest FDA-listed patent expiry
CompanyBiomarin Pharmaceutical →See this company's full patent-cliff portfolio

Drug detail

Brand nameKUVAN
Active ingredientSAPROPTERIN DIHYDROCHLORIDE
Strength100MG
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2007
Marketing statusRX

Listed patents

PatentExpiresType
7566462*PEDMay 2026—
8003126*PEDMay 2026—
7566462November 2025product
8003126November 2025—

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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.