biologic

Zynteglo

betibeglogene autotemcel

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

Drug detail

Brand nameZynteglo
Active ingredientbetibeglogene autotemcel
Strength1.7-20 X 10^6CELL/ML
Dosage formFor Injection
RouteIntravenous
ModalityBiologic
FDA approvalAugust 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.

Zynteglo patent cliff — loss of exclusivity August 2034 | CliffBio