biologic

Zolgensma

onasemnogene abeparvovec-xioi

Loss of exclusivityNovember 2031FDA regulatory exclusivity expiry
CompanyNovartis Gene Therapies, Inc.

Drug detail

Brand nameZolgensma
Active ingredientonasemnogene abeparvovec-xioi
Strength2x10^13VG/ML
Dosage formInjection
RouteIntravenous
ModalityBiologic
FDA approvalMay 2019
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

Zolgensma patent cliff — loss of exclusivity November 2031 | CliffBio