small molecule

XELJANZ

TOFACITINIB CITRATE

Loss of exclusivityAugust 2028FDA regulatory exclusivity expiry
CompanyPF PRISM CV

Drug detail

Brand nameXELJANZ
Active ingredientTOFACITINIB CITRATE
StrengthEQ 5MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2012
Marketing statusRX

Listed patents

PatentExpiresType
RE41783*PEDJune 2026
RE41783December 2025substance

Regulatory exclusivity

CodeExpires
PEDAugust 2028
M-14February 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.

XELJANZ patent cliff — loss of exclusivity August 2028 | CliffBio