small molecule

PROGRAF

TACROLIMUS

Loss of exclusivityJuly 2028FDA regulatory exclusivity expiry
CompanyAstellas Pharma UsView the full company profile on CliffBio

Drug detail

Brand namePROGRAF
Active ingredientTACROLIMUS
StrengthEQ 0.2MG BASE/PACKET
Dosage formFOR SUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalMay 2018
Marketing statusRX

Regulatory exclusivity

CodeExpires
ODE-360July 2028

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

PROGRAF patent cliff — loss of exclusivity July 2028 | CliffBio