biologic

Skysona

elivaldogene autotemcel

Loss of exclusivitySeptember 2034FDA regulatory exclusivity expiry
CompanyGenetix Biotherapeutics Inc.

Drug detail

Brand nameSkysona
Active ingredientelivaldogene autotemcel
Strength2-30 10^6 CELL/ML
Dosage formInjection
RouteIntravenous
ModalityBiologic
FDA approvalSeptember 2022
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.

Skysona patent cliff — loss of exclusivity September 2034 | CliffBio