biologic

Carvykti

ciltacabtagene autoleucel

Loss of exclusivityFebruary 2034FDA regulatory exclusivity expiry
CompanyJanssen BiotechView the full company profile on CliffBio

Drug detail

Brand nameCarvykti
Active ingredientciltacabtagene autoleucel
Strength0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion
Dosage formFor Injection
RouteIntravenous
ModalityBiologic
FDA approvalFebruary 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.

Carvykti patent cliff — loss of exclusivity February 2034 | CliffBio