small molecule

JAKAFI

RUXOLITINIB PHOSPHATE

Loss of exclusivityMarch 2029FDA regulatory exclusivity expiry
CompanyIncyteView the full company profile on CliffBio

Drug detail

Brand nameJAKAFI
Active ingredientRUXOLITINIB PHOSPHATE
StrengthEQ 15MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalNovember 2011
Marketing statusRX

Listed patents

PatentExpiresType
8722693*PEDDecember 2028
10016429*PEDDecember 2028
8829013*PEDDecember 2028
8822481*PEDDecember 2028
7598257*PEDJune 2028
8415362*PEDJune 2028
8722693June 2028substance, product
8822481June 2028use U-3230
8829013June 2028use U-3227
10016429June 2028use U-3230
7598257December 2027substance, product
8415362December 2027substance, product
9079912*PEDJune 2027
9814722*PEDJune 2027
9814722December 2026use U-3230
9079912December 2026use U-3230

Regulatory exclusivity

CodeExpires
PEDMarch 2029
ODE-373September 2028
PEDNovember 2026
PEDJune 2026
ODE-238May 2026
M-285December 2025

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

JAKAFI patent cliff — loss of exclusivity March 2029 | CliffBio