small molecule

XELJANZ

TOFACITINIB CITRATE

Loss of exclusivityAugust 2028FDA regulatory exclusivity expiry
CompanyPfizerView the full company profile on CliffBio

Drug detail

Brand nameXELJANZ
Active ingredientTOFACITINIB CITRATE
StrengthEQ 1MG BASE/ML
Dosage formSOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2020
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