biologic

tecelra

afamitresgene autoleucel

Loss of exclusivityAugust 2036FDA regulatory exclusivity expiry
CompanyUSWM CT, LLC

Drug detail

Brand nametecelra
Active ingredientafamitresgene autoleucel
Strength2.68 x 10^9 to 10 x 10^9 CELL/ML
Dosage formSuspension
RouteIntravenous
ModalityBiologic
FDA approvalAugust 2024
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.

tecelra patent cliff — loss of exclusivity August 2036 | CliffBio