JAKAFI — FDA application NDA202192
Listed sponsor: INCYTE CORP · INCY company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 9079912 | 001 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9079912 | 001 | listed patent expiry date: 2026-12-12 | U-3228 |
| Patent 9079912 | 001 | listed patent expiry date: 2026-12-12 | U-3227 |
| Patent 9079912 | 001 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9079912 | 002 | listed patent expiry date: 2026-12-12 | U-3227 |
| Patent 9079912 | 002 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9079912 | 002 | listed patent expiry date: 2026-12-12 | U-3228 |
| Patent 9079912 | 002 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9079912 | 003 | listed patent expiry date: 2026-12-12 | U-3228 |
| Patent 9079912 | 003 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9079912 | 003 | listed patent expiry date: 2026-12-12 | U-3227 |
| Patent 9079912 | 003 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9079912 | 004 | listed patent expiry date: 2026-12-12 | U-3227 |
| Patent 9079912 | 004 | listed patent expiry date: 2026-12-12 | U-3228 |
| Patent 9079912 | 004 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9079912 | 004 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9079912 | 005 | listed patent expiry date: 2026-12-12 | U-3228 |
| Patent 9079912 | 005 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9079912 | 005 | listed patent expiry date: 2026-12-12 | U-3227 |
| Patent 9079912 | 005 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9814722 | 001 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9814722 | 001 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9814722 | 002 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9814722 | 002 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9814722 | 003 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9814722 | 003 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9814722 | 004 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9814722 | 004 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9814722 | 005 | listed patent expiry date: 2026-12-12 | U-3226 |
| Patent 9814722 | 005 | listed patent expiry date: 2026-12-12 | U-3230 |
| Patent 9079912 | 001 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9079912 | 002 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9079912 | 003 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9079912 | 004 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9079912 | 005 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9814722 | 001 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9814722 | 002 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9814722 | 003 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9814722 | 004 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 9814722 | 005 | listed patent expiry date: 2027-06-12 | pediatric extension |
| Patent 7598257 | 001 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3228 |
| Patent 7598257 | 001 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3227 |
| Patent 7598257 | 002 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3228 |
| Patent 7598257 | 002 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3227 |
| Patent 7598257 | 003 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3228 |
| Patent 7598257 | 003 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3227 |
| Patent 7598257 | 004 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3227 |
| Patent 7598257 | 004 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3228 |
| Patent 7598257 | 005 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3227 |
| Patent 7598257 | 005 | listed patent expiry date: 2027-12-24 | drug substance, drug product, U-3228 |
| Patent 8415362 | 001 | listed patent expiry date: 2027-12-24 | drug substance, drug product |
| Patent 8415362 | 002 | listed patent expiry date: 2027-12-24 | drug substance, drug product |
| Patent 8415362 | 003 | listed patent expiry date: 2027-12-24 | drug substance, drug product |
| Patent 8415362 | 004 | listed patent expiry date: 2027-12-24 | drug substance, drug product |
| Patent 8415362 | 005 | listed patent expiry date: 2027-12-24 | drug substance, drug product |
| Patent 10016429 | 001 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 10016429 | 001 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 10016429 | 002 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 10016429 | 002 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 10016429 | 003 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 10016429 | 003 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 10016429 | 004 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 10016429 | 004 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 10016429 | 005 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 10016429 | 005 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8722693 | 001 | listed patent expiry date: 2028-06-12 | drug substance, drug product |
| Patent 8722693 | 002 | listed patent expiry date: 2028-06-12 | drug substance, drug product |
| Patent 8722693 | 003 | listed patent expiry date: 2028-06-12 | drug substance, drug product |
| Patent 8722693 | 004 | listed patent expiry date: 2028-06-12 | drug substance, drug product |
| Patent 8722693 | 005 | listed patent expiry date: 2028-06-12 | drug substance, drug product |
| Patent 8822481 | 001 | listed patent expiry date: 2028-06-12 | U-1573 |
| Patent 8822481 | 001 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 8822481 | 001 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8822481 | 001 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8822481 | 001 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8822481 | 002 | listed patent expiry date: 2028-06-12 | U-1573 |
| Patent 8822481 | 002 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8822481 | 002 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 8822481 | 002 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8822481 | 002 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8822481 | 003 | listed patent expiry date: 2028-06-12 | U-1573 |
| Patent 8822481 | 003 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 8822481 | 003 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8822481 | 003 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8822481 | 003 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8822481 | 004 | listed patent expiry date: 2028-06-12 | U-1573 |
| Patent 8822481 | 004 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 8822481 | 004 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8822481 | 004 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8822481 | 004 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8822481 | 005 | listed patent expiry date: 2028-06-12 | U-1573 |
| Patent 8822481 | 005 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8822481 | 005 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8822481 | 005 | listed patent expiry date: 2028-06-12 | U-3226 |
| Patent 8822481 | 005 | listed patent expiry date: 2028-06-12 | U-3230 |
| Patent 8829013 | 001 | listed patent expiry date: 2028-06-12 | U-1622 |
| Patent 8829013 | 001 | listed patent expiry date: 2028-06-12 | U-1201 |
| Patent 8829013 | 001 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8829013 | 001 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8829013 | 002 | listed patent expiry date: 2028-06-12 | U-1201 |
| Patent 8829013 | 002 | listed patent expiry date: 2028-06-12 | U-1622 |
| Patent 8829013 | 002 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8829013 | 002 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8829013 | 003 | listed patent expiry date: 2028-06-12 | U-1201 |
| Patent 8829013 | 003 | listed patent expiry date: 2028-06-12 | U-1622 |
| Patent 8829013 | 003 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8829013 | 003 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8829013 | 004 | listed patent expiry date: 2028-06-12 | U-1622 |
| Patent 8829013 | 004 | listed patent expiry date: 2028-06-12 | U-1201 |
| Patent 8829013 | 004 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 8829013 | 004 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8829013 | 005 | listed patent expiry date: 2028-06-12 | U-1622 |
| Patent 8829013 | 005 | listed patent expiry date: 2028-06-12 | U-1201 |
| Patent 8829013 | 005 | listed patent expiry date: 2028-06-12 | U-3228 |
| Patent 8829013 | 005 | listed patent expiry date: 2028-06-12 | U-3227 |
| Patent 7598257 | 001 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 7598257 | 002 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 7598257 | 003 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 7598257 | 004 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 7598257 | 005 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 8415362 | 001 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 8415362 | 002 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 8415362 | 003 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 8415362 | 004 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 8415362 | 005 | listed patent expiry date: 2028-06-24 | pediatric extension |
| Patent 10016429 | 001 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 10016429 | 002 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 10016429 | 003 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 10016429 | 004 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 10016429 | 005 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8722693 | 001 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8722693 | 002 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8722693 | 003 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8722693 | 004 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8722693 | 005 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8822481 | 001 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8822481 | 002 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8822481 | 003 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8822481 | 004 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8822481 | 005 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8829013 | 001 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8829013 | 002 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8829013 | 003 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8829013 | 004 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Patent 8829013 | 005 | listed patent expiry date: 2028-12-12 | pediatric extension |
| Exclusivity M-285 | 001 | listed exclusivity date: 2025-12-19 | FDA code as listed |
| Exclusivity M-285 | 002 | listed exclusivity date: 2025-12-19 | FDA code as listed |
| Exclusivity M-285 | 003 | listed exclusivity date: 2025-12-19 | FDA code as listed |
| Exclusivity M-285 | 004 | listed exclusivity date: 2025-12-19 | FDA code as listed |
| Exclusivity M-285 | 005 | listed exclusivity date: 2025-12-19 | FDA code as listed |
| Exclusivity ODE-238 | 001 | listed exclusivity date: 2026-05-24 | FDA code as listed |
| Exclusivity ODE-238 | 002 | listed exclusivity date: 2026-05-24 | FDA code as listed |
| Exclusivity ODE-238 | 003 | listed exclusivity date: 2026-05-24 | FDA code as listed |
| Exclusivity ODE-238 | 004 | listed exclusivity date: 2026-05-24 | FDA code as listed |
| Exclusivity ODE-238 | 005 | listed exclusivity date: 2026-05-24 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2026-06-19 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2026-06-19 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2026-06-19 | FDA code as listed |
| Exclusivity PED | 004 | listed exclusivity date: 2026-06-19 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2026-06-19 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2026-11-24 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2026-11-24 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2026-11-24 | FDA code as listed |
| Exclusivity PED | 004 | listed exclusivity date: 2026-11-24 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2026-11-24 | FDA code as listed |
| Exclusivity ODE-373 | 001 | listed exclusivity date: 2028-09-22 | FDA code as listed |
| Exclusivity ODE-373 | 002 | listed exclusivity date: 2028-09-22 | FDA code as listed |
| Exclusivity ODE-373 | 003 | listed exclusivity date: 2028-09-22 | FDA code as listed |
| Exclusivity ODE-373 | 004 | listed exclusivity date: 2028-09-22 | FDA code as listed |
| Exclusivity ODE-373 | 005 | listed exclusivity date: 2028-09-22 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2029-03-22 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2029-03-22 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2029-03-22 | FDA code as listed |
| Exclusivity PED | 004 | listed exclusivity date: 2029-03-22 | FDA code as listed |
| Exclusivity PED | 005 | listed exclusivity date: 2029-03-22 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.