biologic

Lenmeldy

atidarsagene autotemcel

Loss of exclusivityMarch 2036FDA regulatory exclusivity expiry
CompanyOrchard Therapeutics (Europe) Ltd.

Drug detail

Brand nameLenmeldy
Active ingredientatidarsagene autotemcel
Strength2 x 10^6 to 11.8 x 10^6CELL/ML
Dosage formSuspension
RouteIntravenous
ModalityBiologic
FDA approvalMarch 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.

Lenmeldy patent cliff — loss of exclusivity March 2036 | CliffBio