small molecule

OPZELURA

RUXOLITINIB PHOSPHATE

Loss of exclusivityMay 2041latest FDA-listed patent expiry
CompanyIncyte →See this company's full patent-cliff portfolio

Drug detail

Brand nameOPZELURA
Active ingredientRUXOLITINIB PHOSPHATE
StrengthEQ 1.5% BASE
Dosage formCREAM
RouteTOPICAL
ModalitySmall molecule
FDA approvalSeptember 2021
Marketing statusRX

Listed patents

PatentExpiresType
11602536May 2041use U-3550
11590137September 2040use U-3505
11510923September 2040use U-3505
12589096September 2040use U-3505
12233067July 2040use U-4151
11590138June 2040use U-3551
11219624*PEDNovember 2031—
10758543*PEDNovember 2031—
10869870*PEDNovember 2031—
12544381May 2031product
10869870May 2031use U-3229
11219624May 2031product
11590136May 2031use U-3404
12564593May 2031product
10758543May 2031product
12226419May 2031product
11571425May 2031product
8822481*PEDDecember 2028—
10610530*PEDDecember 2028—
8722693*PEDDecember 2028—
7598257*PEDJune 2028—
8415362*PEDJune 2028—
8822481June 2028use U-3229
10610530June 2028use U-3229
8722693June 2028substance, product
8415362December 2027substance, product
7598257December 2027substance, product
9974790*PEDJune 2027—
10639310*PEDJune 2027—
9079912*PEDJune 2027—
9079912December 2026use U-3229
10639310December 2026use U-3229
9974790December 2026use U-3229

Regulatory exclusivity

CodeExpires
NPPSeptember 2028
PEDJanuary 2026
I-896July 2025

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.