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 0.5MG BASE
Dosage formCAPSULE
RouteORAL
ModalitySmall molecule
FDA approvalAugust 1998
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