# JAKAFI — FDA application NDA202192 Informational only - not investment advice. Application NDA202192 · type NDA · FDA status: approved · original approval 2011-11-16 Listed sponsor: INCYTE CORP · [INCY company profile](/company/INCY/) · exact_unique Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers. ## FDA application facts | Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 001 | JAKAFI | RUXOLITINIB PHOSPHATE | TABLET | ORAL | EQ 5MG BASE | Prescription | not listed | Yes | | 002 | JAKAFI | RUXOLITINIB PHOSPHATE | TABLET | ORAL | EQ 10MG BASE | Prescription | not listed | Yes | | 003 | JAKAFI | RUXOLITINIB PHOSPHATE | TABLET | ORAL | EQ 15MG BASE | Prescription | not listed | Yes | | 004 | JAKAFI | RUXOLITINIB PHOSPHATE | TABLET | ORAL | EQ 20MG BASE | Prescription | not listed | Yes | | 005 | JAKAFI | RUXOLITINIB PHOSPHATE | TABLET | ORAL | EQ 25MG BASE | Prescription | not listed | Yes | ## Orange Book patent and exclusivity listings - Patent 9079912, product 001; listed patent expiry date: 2026-12-12. - Patent 9079912, product 001; listed patent expiry date: 2026-12-12. - Patent 9079912, product 001; listed patent expiry date: 2026-12-12. - Patent 9079912, product 001; listed patent expiry date: 2026-12-12. - Patent 9079912, product 002; listed patent expiry date: 2026-12-12. - Patent 9079912, product 002; listed patent expiry date: 2026-12-12. - Patent 9079912, product 002; listed patent expiry date: 2026-12-12. - Patent 9079912, product 002; listed patent expiry date: 2026-12-12. - Patent 9079912, product 003; listed patent expiry date: 2026-12-12. - Patent 9079912, product 003; listed patent expiry date: 2026-12-12. - Patent 9079912, product 003; listed patent expiry date: 2026-12-12. - Patent 9079912, product 003; listed patent expiry date: 2026-12-12. - Patent 9079912, product 004; listed patent expiry date: 2026-12-12. - Patent 9079912, product 004; listed patent expiry date: 2026-12-12. - Patent 9079912, product 004; listed patent expiry date: 2026-12-12. - Patent 9079912, product 004; listed patent expiry date: 2026-12-12. - Patent 9079912, product 005; listed patent expiry date: 2026-12-12. - Patent 9079912, product 005; listed patent expiry date: 2026-12-12. - Patent 9079912, product 005; listed patent expiry date: 2026-12-12. - Patent 9079912, product 005; listed patent expiry date: 2026-12-12. - Patent 9814722, product 001; listed patent expiry date: 2026-12-12. - Patent 9814722, product 001; listed patent expiry date: 2026-12-12. - Patent 9814722, product 002; listed patent expiry date: 2026-12-12. - Patent 9814722, product 002; listed patent expiry date: 2026-12-12. - Patent 9814722, product 003; listed patent expiry date: 2026-12-12. - Patent 9814722, product 003; listed patent expiry date: 2026-12-12. - Patent 9814722, product 004; listed patent expiry date: 2026-12-12. - Patent 9814722, product 004; listed patent expiry date: 2026-12-12. - Patent 9814722, product 005; listed patent expiry date: 2026-12-12. - Patent 9814722, product 005; listed patent expiry date: 2026-12-12. - Patent 9079912, product 001; listed patent expiry date: 2027-06-12. - Patent 9079912, product 002; listed patent expiry date: 2027-06-12. - Patent 9079912, product 003; listed patent expiry date: 2027-06-12. - Patent 9079912, product 004; listed patent expiry date: 2027-06-12. - Patent 9079912, product 005; listed patent expiry date: 2027-06-12. - Patent 9814722, product 001; listed patent expiry date: 2027-06-12. - Patent 9814722, product 002; listed patent expiry date: 2027-06-12. - Patent 9814722, product 003; listed patent expiry date: 2027-06-12. - Patent 9814722, product 004; listed patent expiry date: 2027-06-12. - Patent 9814722, product 005; listed patent expiry date: 2027-06-12. - Patent 7598257, product 001; listed patent expiry date: 2027-12-24. - Patent 7598257, product 001; listed patent expiry date: 2027-12-24. - Patent 7598257, product 002; listed patent expiry date: 2027-12-24. - Patent 7598257, product 002; listed patent expiry date: 2027-12-24. - Patent 7598257, product 003; listed patent expiry date: 2027-12-24. - Patent 7598257, product 003; listed patent expiry date: 2027-12-24. - Patent 7598257, product 004; listed patent expiry date: 2027-12-24. - Patent 7598257, product 004; listed patent expiry date: 2027-12-24. - Patent 7598257, product 005; listed patent expiry date: 2027-12-24. - Patent 7598257, product 005; listed patent expiry date: 2027-12-24. - Patent 8415362, product 001; listed patent expiry date: 2027-12-24. - Patent 8415362, product 002; listed patent expiry date: 2027-12-24. - Patent 8415362, product 003; listed patent expiry date: 2027-12-24. - Patent 8415362, product 004; listed patent expiry date: 2027-12-24. - Patent 8415362, product 005; listed patent expiry date: 2027-12-24. - Patent 10016429, product 001; listed patent expiry date: 2028-06-12. - Patent 10016429, product 001; listed patent expiry date: 2028-06-12. - Patent 10016429, product 002; listed patent expiry date: 2028-06-12. - Patent 10016429, product 002; listed patent expiry date: 2028-06-12. - Patent 10016429, product 003; listed patent expiry date: 2028-06-12. - Patent 10016429, product 003; listed patent expiry date: 2028-06-12. - Patent 10016429, product 004; listed patent expiry date: 2028-06-12. - Patent 10016429, product 004; listed patent expiry date: 2028-06-12. - Patent 10016429, product 005; listed patent expiry date: 2028-06-12. - Patent 10016429, product 005; listed patent expiry date: 2028-06-12. - Patent 8722693, product 001; listed patent expiry date: 2028-06-12. - Patent 8722693, product 002; listed patent expiry date: 2028-06-12. - Patent 8722693, product 003; listed patent expiry date: 2028-06-12. - Patent 8722693, product 004; listed patent expiry date: 2028-06-12. - Patent 8722693, product 005; listed patent expiry date: 2028-06-12. - Patent 8822481, product 001; listed patent expiry date: 2028-06-12. - Patent 8822481, product 001; listed patent expiry date: 2028-06-12. - Patent 8822481, product 001; listed patent expiry date: 2028-06-12. - Patent 8822481, product 001; listed patent expiry date: 2028-06-12. - Patent 8822481, product 001; listed patent expiry date: 2028-06-12. - Patent 8822481, product 002; listed patent expiry date: 2028-06-12. - Patent 8822481, product 002; listed patent expiry date: 2028-06-12. - Patent 8822481, product 002; listed patent expiry date: 2028-06-12. - Patent 8822481, product 002; listed patent expiry date: 2028-06-12. - Patent 8822481, product 002; listed patent expiry date: 2028-06-12. - Patent 8822481, product 003; listed patent expiry date: 2028-06-12. - Patent 8822481, product 003; listed patent expiry date: 2028-06-12. - Patent 8822481, product 003; listed patent expiry date: 2028-06-12. - Patent 8822481, product 003; listed patent expiry date: 2028-06-12. - Patent 8822481, product 003; listed patent expiry date: 2028-06-12. - Patent 8822481, product 004; listed patent expiry date: 2028-06-12. - Patent 8822481, product 004; listed patent expiry date: 2028-06-12. - Patent 8822481, product 004; listed patent expiry date: 2028-06-12. - Patent 8822481, product 004; listed patent expiry date: 2028-06-12. - Patent 8822481, product 004; listed patent expiry date: 2028-06-12. - Patent 8822481, product 005; listed patent expiry date: 2028-06-12. - Patent 8822481, product 005; listed patent expiry date: 2028-06-12. - Patent 8822481, product 005; listed patent expiry date: 2028-06-12. - Patent 8822481, product 005; listed patent expiry date: 2028-06-12. - Patent 8822481, product 005; listed patent expiry date: 2028-06-12. - Patent 8829013, product 001; listed patent expiry date: 2028-06-12. - Patent 8829013, product 001; listed patent expiry date: 2028-06-12. - Patent 8829013, product 001; listed patent expiry date: 2028-06-12. - Patent 8829013, product 001; listed patent expiry date: 2028-06-12. - Patent 8829013, product 002; listed patent expiry date: 2028-06-12. - Patent 8829013, product 002; listed patent expiry date: 2028-06-12. - Patent 8829013, product 002; listed patent expiry date: 2028-06-12. - Patent 8829013, product 002; listed patent expiry date: 2028-06-12. - Patent 8829013, product 003; listed patent expiry date: 2028-06-12. - Patent 8829013, product 003; listed patent expiry date: 2028-06-12. - Patent 8829013, product 003; listed patent expiry date: 2028-06-12. - Patent 8829013, product 003; listed patent expiry date: 2028-06-12. - Patent 8829013, product 004; listed patent expiry date: 2028-06-12. - Patent 8829013, product 004; listed patent expiry date: 2028-06-12. - Patent 8829013, product 004; listed patent expiry date: 2028-06-12. - Patent 8829013, product 004; listed patent expiry date: 2028-06-12. - Patent 8829013, product 005; listed patent expiry date: 2028-06-12. - Patent 8829013, product 005; listed patent expiry date: 2028-06-12. - Patent 8829013, product 005; listed patent expiry date: 2028-06-12. - Patent 8829013, product 005; listed patent expiry date: 2028-06-12. - Patent 7598257, product 001; listed patent expiry date: 2028-06-24. - Patent 7598257, product 002; listed patent expiry date: 2028-06-24. - Patent 7598257, product 003; listed patent expiry date: 2028-06-24. - Patent 7598257, product 004; listed patent expiry date: 2028-06-24. - Patent 7598257, product 005; listed patent expiry date: 2028-06-24. - Patent 8415362, product 001; listed patent expiry date: 2028-06-24. - Patent 8415362, product 002; listed patent expiry date: 2028-06-24. - Patent 8415362, product 003; listed patent expiry date: 2028-06-24. - Patent 8415362, product 004; listed patent expiry date: 2028-06-24. - Patent 8415362, product 005; listed patent expiry date: 2028-06-24. - Patent 10016429, product 001; listed patent expiry date: 2028-12-12. - Patent 10016429, product 002; listed patent expiry date: 2028-12-12. - Patent 10016429, product 003; listed patent expiry date: 2028-12-12. - Patent 10016429, product 004; listed patent expiry date: 2028-12-12. - Patent 10016429, product 005; listed patent expiry date: 2028-12-12. - Patent 8722693, product 001; listed patent expiry date: 2028-12-12. - Patent 8722693, product 002; listed patent expiry date: 2028-12-12. - Patent 8722693, product 003; listed patent expiry date: 2028-12-12. - Patent 8722693, product 004; listed patent expiry date: 2028-12-12. - Patent 8722693, product 005; listed patent expiry date: 2028-12-12. - Patent 8822481, product 001; listed patent expiry date: 2028-12-12. - Patent 8822481, product 002; listed patent expiry date: 2028-12-12. - Patent 8822481, product 003; listed patent expiry date: 2028-12-12. - Patent 8822481, product 004; listed patent expiry date: 2028-12-12. - Patent 8822481, product 005; listed patent expiry date: 2028-12-12. - Patent 8829013, product 001; listed patent expiry date: 2028-12-12. - Patent 8829013, product 002; listed patent expiry date: 2028-12-12. - Patent 8829013, product 003; listed patent expiry date: 2028-12-12. - Patent 8829013, product 004; listed patent expiry date: 2028-12-12. - Patent 8829013, product 005; listed patent expiry date: 2028-12-12. - Exclusivity M-285, product 001; listed exclusivity date: 2025-12-19. - Exclusivity M-285, product 002; listed exclusivity date: 2025-12-19. - Exclusivity M-285, product 003; listed exclusivity date: 2025-12-19. - Exclusivity M-285, product 004; listed exclusivity date: 2025-12-19. - Exclusivity M-285, product 005; listed exclusivity date: 2025-12-19. - Exclusivity ODE-238, product 001; listed exclusivity date: 2026-05-24. - Exclusivity ODE-238, product 002; listed exclusivity date: 2026-05-24. - Exclusivity ODE-238, product 003; listed exclusivity date: 2026-05-24. - Exclusivity ODE-238, product 004; listed exclusivity date: 2026-05-24. - Exclusivity ODE-238, product 005; listed exclusivity date: 2026-05-24. - Exclusivity PED, product 001; listed exclusivity date: 2026-06-19. - Exclusivity PED, product 002; listed exclusivity date: 2026-06-19. - Exclusivity PED, product 003; listed exclusivity date: 2026-06-19. - Exclusivity PED, product 004; listed exclusivity date: 2026-06-19. - Exclusivity PED, product 005; listed exclusivity date: 2026-06-19. - Exclusivity PED, product 001; listed exclusivity date: 2026-11-24. - Exclusivity PED, product 002; listed exclusivity date: 2026-11-24. - Exclusivity PED, product 003; listed exclusivity date: 2026-11-24. - Exclusivity PED, product 004; listed exclusivity date: 2026-11-24. - Exclusivity PED, product 005; listed exclusivity date: 2026-11-24. - Exclusivity ODE-373, product 001; listed exclusivity date: 2028-09-22. - Exclusivity ODE-373, product 002; listed exclusivity date: 2028-09-22. - Exclusivity ODE-373, product 003; listed exclusivity date: 2028-09-22. - Exclusivity ODE-373, product 004; listed exclusivity date: 2028-09-22. - Exclusivity ODE-373, product 005; listed exclusivity date: 2028-09-22. - Exclusivity PED, product 001; listed exclusivity date: 2029-03-22. - Exclusivity PED, product 002; listed exclusivity date: 2029-03-22. - Exclusivity PED, product 003; listed exclusivity date: 2029-03-22. - Exclusivity PED, product 004; listed exclusivity date: 2029-03-22. - Exclusivity PED, product 005; listed exclusivity date: 2029-03-22. Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied. ## Compound cross-links - RUXOLITINIB · UNII 82S8X8XX8H · no lmmol compound match Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link. ## Related pages - [Sponsor company](/company/INCY/) - [FDA-approved application index](/drug/) Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA202192. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.