FDA Orange Book · active-ingredient family
Ruxolitinib phosphate
Ruxolitinib phosphate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
3
Brand (NDA)
0
Generics (ANDA)
48
Listed patents
33
Exclusivity periods
Brand (NDA) products · cream, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JAKAFI XRRLD×5 | INCYTE CORP | NDA 217180 | — | May 01, 2026 | |
| OPZELURARLD | INCYTE CORP | NDA 215309 | — | Sep 21, 2021 | |
| JAKAFIRLD×5 | INCYTE CORP | NDA 202192 | — | Nov 16, 2011 |
Marketing exclusivity (33)
- I-896New indication exclusivity (3 years)
Jul 18, 2025
11 mo ago
- NPPNew patient population exclusivity (3 years)
Sep 18, 2028
in 2 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Jan 18, 2026
5 mo ago
- M-285New use / labeling-change exclusivity (3 years)
Dec 19, 2025
6 mo ago
- ODE-238Orphan-drug exclusivity (7 years)
May 24, 2026
26 d ago
- ODE-373Orphan-drug exclusivity (7 years)
Sep 22, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 24, 2026
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 19, 2026
today
- PEDPediatric exclusivity (adds 6 months)
Mar 22, 2029
in 2 yr 10 mo
- M-285New use / labeling-change exclusivity (3 years)
Dec 19, 2025
6 mo ago
- ODE-238Orphan-drug exclusivity (7 years)
May 24, 2026
26 d ago
- ODE-373Orphan-drug exclusivity (7 years)
Sep 22, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 24, 2026
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 19, 2026
today
- PEDPediatric exclusivity (adds 6 months)
Mar 22, 2029
in 2 yr 10 mo
- M-285New use / labeling-change exclusivity (3 years)
Dec 19, 2025
6 mo ago
- ODE-238Orphan-drug exclusivity (7 years)
May 24, 2026
26 d ago
- ODE-373Orphan-drug exclusivity (7 years)
Sep 22, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 24, 2026
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 19, 2026
today
- PEDPediatric exclusivity (adds 6 months)
Mar 22, 2029
in 2 yr 10 mo
- M-285New use / labeling-change exclusivity (3 years)
Dec 19, 2025
6 mo ago
- ODE-238Orphan-drug exclusivity (7 years)
May 24, 2026
26 d ago
- ODE-373Orphan-drug exclusivity (7 years)
Sep 22, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 24, 2026
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 19, 2026
today
- PEDPediatric exclusivity (adds 6 months)
Mar 22, 2029
in 2 yr 10 mo
- M-285New use / labeling-change exclusivity (3 years)
Dec 19, 2025
6 mo ago
- ODE-238Orphan-drug exclusivity (7 years)
May 24, 2026
26 d ago
- ODE-373Orphan-drug exclusivity (7 years)
Sep 22, 2028
in 2 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Nov 24, 2026
in 5 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 19, 2026
today
- PEDPediatric exclusivity (adds 6 months)
Mar 22, 2029
in 2 yr 10 mo
Listed patents (48)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9079912 | Dec 12, 2026 | in 6 mo | U-3404 |
| 9974790 | Dec 12, 2026 | in 6 mo | U-3404 |
| 10639310 | Dec 12, 2026 | in 6 mo | U-3229 |
| 9814722 | Dec 12, 2026 | in 6 mo | U-3226 |
| 9206187 | Dec 12, 2026 | in 6 mo | U-3227 |
| 11744832 | Dec 12, 2026 | in 6 mo | U-3226 |
| 8530485 | Dec 12, 2026 | in 6 mo | Product |
| 9079912*PED | Jun 12, 2027 | in 1 yr | |
| 9974790*PED | Jun 12, 2027 | in 1 yr | |
| 10639310*PED | Jun 12, 2027 | in 1 yr | |
| 9814722*PED | Jun 12, 2027 | in 1 yr | |
| 7598257 | Dec 24, 2027 | in 1 yr 6 mo | SubstanceProduct |
| 8415362 | Dec 24, 2027 | in 1 yr 6 mo | SubstanceProduct |
| 8822481 | Jun 12, 2028 | in 2 yr | U-3404 |
| 10610530 | Jun 12, 2028 | in 2 yr | U-3404 |
| 8722693 | Jun 12, 2028 | in 2 yr | SubstanceProduct |
| 8829013 | Jun 12, 2028 | in 2 yr | U-3227 |
| 10016429 | Jun 12, 2028 | in 2 yr | U-3226 |
| 11213528 | Jun 12, 2028 | in 2 yr | Product |
| 7598257*PED | Jun 24, 2028 | in 2 yr 1 mo | |
| 8415362*PED | Jun 24, 2028 | in 2 yr 1 mo | |
| 8722693*PED | Dec 12, 2028 | in 2 yr 6 mo | |
| 8822481*PED | Dec 12, 2028 | in 2 yr 6 mo | |
| 10610530*PED | Dec 12, 2028 | in 2 yr 6 mo | |
| 8829013*PED | Dec 12, 2028 | in 2 yr 6 mo | |
| 10016429*PED | Dec 12, 2028 | in 2 yr 6 mo | |
| 10869870 | May 20, 2031 | in 5 yr | U-3404 |
| 11219624 | May 20, 2031 | in 5 yr | ProductU-3229 |
| 11590136 | May 20, 2031 | in 5 yr | U-3229 |
| 12544381 | May 20, 2031 | in 5 yr | Product |
| 12564593 | May 20, 2031 | in 5 yr | Product |
| 10758543 | May 20, 2031 | in 5 yr | Product |
| 12226419 | May 20, 2031 | in 5 yr | Product |
| 11571425 | May 20, 2031 | in 5 yr | Product |
| 11219624*PED | Nov 20, 2031 | in 5 yr 6 mo | |
| 10758543*PED | Nov 20, 2031 | in 5 yr 6 mo | |
| 10869870*PED | Nov 20, 2031 | in 5 yr 6 mo | |
| 11576864 | Nov 14, 2033 | in 7 yr 6 mo | U-3227 |
| 11896717 | Nov 14, 2033 | in 7 yr 6 mo | ProductU-3227 |
| 11576865 | Nov 14, 2033 | in 7 yr 6 mo | ProductU-3227 |
| 10874616 | Nov 14, 2033 | in 7 yr 6 mo | Product |
| 11337927 | Jan 17, 2034 | in 7 yr 8 mo | U-3227 |
| 11590138 | Jun 10, 2040 | in 14 yr 2 mo | U-3551 |
| 12233067 | Jul 28, 2040 | in 14 yr 4 mo | U-4151 |
| 11510923 | Sep 04, 2040 | in 14 yr 5 mo | U-3505 |
| 11590137 | Sep 04, 2040 | in 14 yr 5 mo | U-3505 |
| 12589096 | Sep 04, 2040 | in 14 yr 5 mo | U-3505 |
| 11602536 | May 05, 2041 | in 15 yr 1 mo | U-3550 |
Ruxolitinib phosphate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
