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 | — | |
| 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 | — | — | — | |
| 8829013 | Jun 12, 2028PED: Dec 12, 2028 | PED | — | — | — | |
| 9079912 | Dec 12, 2026 | — | — | — | — | |
| 9206187 | Dec 12, 2026 | — | — | — | — | |
| 9814722 | Dec 12, 2026 | — | — | — | — | |
| 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 | — | — | — | |
| 11576864 | Nov 14, 2033PED: May 14, 2034 | PED | — | — | — | |
| 11576865 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — | |
| 11744832 | Dec 12, 2026 | — | — | — | — | |
| 11896717 | Nov 14, 2033PED: May 14, 2034 | PED | — | Yes | — |
| Code | Date | Status |
|---|---|---|
| ODE*Newly listed — daily FDA feed, not yet in monthly Orange Book edition | Sep 22, 2028 | Active |
| ODE**PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Mar 22, 2029 | Active |
JAKAFI XR (ruxolitinib phosphate) received orphan drug exclusivity expiring Sep 2028.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE* exp 09/22/2028
Incyte received orphan drug exclusivity for JAKAFI XR (ruxolitinib phosphate) expiring Sep 2028.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE* exp 09/22/2028
Incyte Corp received orphan drug exclusivity for JAKAFI XR (ruxolitinib phosphate) expiring Mar 2029.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
INCYTE CORP gained pediatric exclusivity for JAKAFI XR (ruxolitinib phosphate) expiring Mar 2029, extending the product's regulatory protection.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) received orphan drug exclusivity designation with expiration date Mar 2029.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029, providing regulatory protection for the extended-release formulation.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Sep 2028 for NDA 217180, supplement 002.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE* exp 09/22/2028
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Mar 2029 for a supplemental application.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE**PED exp 03/22/2029
JAKAFI XR (ruxolitinib phosphate) gained orphan drug exclusivity expiring Sep 2028 for NDA 217180, supplement 004.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE* exp 09/22/2028
Incyte Corp's supplemental application for JAKAFI XR (ruxolitinib phosphate) gained Orphan Drug Exclusivity expiring Sep 2028.
New: JAKAFI XR (RUXOLITINIB PHOSPHATE) — exclusivity ODE* exp 09/22/2028