RUXOLITINIB PHOSPHATE | N217180 | INCYTE CORP
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7598257 | Dec 24, 2027PED: Jun 24, 2028 | PED | Yes | Yes | — | |
| 7598257 | Dec 24, 2027PED: Jun 24, 2028 | PED | Yes | Yes | — | |
| 8415362 | Dec 24, 2027PED: Jun 24, 2028 | PED | Yes | Yes | — | — |
| 8530485 | Dec 12, 2026 | — | — | Yes | — | — |
| 8722693 | Jun 12, 2028PED: Dec 12, 2028 | PED | Yes | Yes | — | — |
| 8822481 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 8822481 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 8822481 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 8822481 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 8829013 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 8829013 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 9079912 | Dec 12, 2026 | — | — | — | — | |
| 9079912 | Dec 12, 2026 | — | — | — | — | |
| 9079912 | Dec 12, 2026 | — | — | — | — | |
| 9079912 | Dec 12, 2026 | — | — | — | — | |
| 9206187 | Dec 12, 2026 | — | — | — | — | |
| 9206187 | Dec 12, 2026 | — | — | — | — | |
| 9814722 | Dec 12, 2026 | — | — | — | — | |
| 9814722 | Dec 12, 2026 | — | — | — | — | |
| 10016429 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 10016429 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 10874616 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | — |
| 11213528 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | Yes | — | — |
| 11337927 | Jan 17, 2034PED: Jul 17, 2034 | PED | — | — | — | |
| 11337927 | Jan 17, 2034PED: Jul 17, 2034 | PED | — | — | — | |
| 11337927 | Jan 17, 2034PED: Jul 17, 2034 | PED | — | — | — | |
| 11337927 | Jan 17, 2034PED: Jul 17, 2034 | PED | — | — | — | |
| 11576864 | Nov 14, 2033PED: May 14, 2034 | PED | — | — | — | |
| 11576864 | Nov 14, 2033PED: May 14, 2034 | PED | — | — | — | |
| 11576864 | Nov 14, 2033PED: May 14, 2034 | PED | — | — | — | |
| 11576864 | Nov 14, 2033PED: May 14, 2034 | PED | — | — | — | |
| 11576865 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11576865 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11576865 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11576865 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11744832 | Dec 12, 2026 | — | — | — | — | |
| 11744832 | Dec 12, 2026 | — | — | — | — | |
| 11896717 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11896717 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11896717 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11896717 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| ODE* | Sep 22, 2028 | Active |
| PED | Mar 22, 2029 | Active |
Incyte Corp's JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029, extending regulatory protection for this indication under the orphan drug program.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
Incyte's JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029, as recorded in the FDA database for NDA 217180.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
Incyte added orphan drug exclusivity (expiring Mar 2029) to the JAKAFI XR (ruxolitinib phosphate) NDA, providing regulatory protection for this indication through early 2029.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity with expiration in Mar 2029, extending regulatory protection for this indication.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029