biologic

Krystexxa

pegloticase

Loss of exclusivityAugust 2037projected — 12-year biologic exclusivity estimate
CompanyHorizon Therapeutics Ireland DAC

Drug detail

Brand nameKrystexxa
Active ingredientpegloticase
Strength8MG/50ML (0.16MG/ML)
Dosage formInjection
RouteIntravenous
ModalityBiologic
FDA approvalAugust 2025
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the projected — 12-year biologic exclusivity estimate; estimates are projections, not legal advice.

Krystexxa patent cliff — loss of exclusivity August 2037 | CliffBio