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Orange Book product · Brand (NDA)

JAKAFI XR

RUXOLITINIB PHOSPHATE

Brand (NDA)NDA 217180RX INCYTE CORP
View RUXOLITINIB PHOSPHATE familyOpen on FDA Orange Book

At a glance

May 01, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

41

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 01, 2026

    2 mo ago

  2. Today

  3. Patent 11744832 expires

    Listed method-of-use patent (U-3226) expiration.

    Dec 12, 2026

    in 6 mo

  4. Patent 11744832 expires

    Listed method-of-use patent (U-3230) expiration.

    Dec 12, 2026

    in 6 mo

  5. Patent 8530485 expires

    Listed drug product patent expiration.

    Dec 12, 2026

    in 6 mo

  6. Patent 9079912 expires

    Listed method-of-use patent (U-3227) expiration.

    Dec 12, 2026

    in 6 mo

  7. Patent 9079912 expires

    Listed method-of-use patent (U-3228) expiration.

    Dec 12, 2026

    in 6 mo

  8. Patent 9079912 expires

    Listed method-of-use patent (U-3230) expiration.

    Dec 12, 2026

    in 6 mo

  9. Patent 9079912 expires

    Listed method-of-use patent (U-3226) expiration.

    Dec 12, 2026

    in 6 mo

  10. Patent 9206187 expires

    Listed method-of-use patent (U-3227) expiration.

    Dec 12, 2026

    in 6 mo

  11. Patent 9206187 expires

    Listed method-of-use patent (U-3228) expiration.

    Dec 12, 2026

    in 6 mo

  12. Patent 9814722 expires

    Listed method-of-use patent (U-3226) expiration.

    Dec 12, 2026

    in 6 mo

  13. Patent 9814722 expires

    Listed method-of-use patent (U-3230) expiration.

    Dec 12, 2026

    in 6 mo

  14. Patent 7598257 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

  15. Patent 7598257 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

  16. Patent 8415362 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

  17. Patent 10016429 expires

    Listed method-of-use patent (U-3226) expiration.

    Jun 12, 2028

    in 2 yr

  18. Patent 10016429 expires

    Listed method-of-use patent (U-3230) expiration.

    Jun 12, 2028

    in 2 yr

  19. Patent 11213528 expires

    Listed drug product patent expiration.

    Jun 12, 2028

    in 2 yr

  20. Patent 8722693 expires

    Listed drug substance patent expiration.

    Jun 12, 2028

    in 2 yr

  21. Patent 8822481 expires

    Listed method-of-use patent (U-3227) expiration.

    Jun 12, 2028

    in 2 yr

  22. Patent 8822481 expires

    Listed method-of-use patent (U-3228) expiration.

    Jun 12, 2028

    in 2 yr

  23. Patent 8822481 expires

    Listed method-of-use patent (U-3230) expiration.

    Jun 12, 2028

    in 2 yr

  24. Patent 8822481 expires

    Listed method-of-use patent (U-3226) expiration.

    Jun 12, 2028

    in 2 yr

  25. Patent 8829013 expires

    Listed method-of-use patent (U-3227) expiration.

    Jun 12, 2028

    in 2 yr

  26. Patent 8829013 expires

    Listed method-of-use patent (U-3228) expiration.

    Jun 12, 2028

    in 2 yr

  27. Patent 10874616 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  28. Patent 11576864 expires

    Listed method-of-use patent (U-3227) expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  29. Patent 11576864 expires

    Listed method-of-use patent (U-3228) expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  30. Patent 11576864 expires

    Listed method-of-use patent (U-3230) expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  31. Patent 11576864 expires

    Listed method-of-use patent (U-3226) expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  32. Patent 11576865 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  33. Patent 11576865 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  34. Patent 11576865 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  35. Patent 11576865 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  36. Patent 11896717 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  37. Patent 11896717 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  38. Patent 11896717 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  39. Patent 11896717 expires

    Listed drug product patent expiration.

    Nov 14, 2033

    in 7 yr 6 mo

  40. Patent 11337927 expires

    Listed method-of-use patent (U-3227) expiration.

    Jan 17, 2034

    in 7 yr 8 mo

  41. Patent 11337927 expires

    Listed method-of-use patent (U-3228) expiration.

    Jan 17, 2034

    in 7 yr 8 mo

  42. Patent 11337927 expires

    Listed method-of-use patent (U-3230) expiration.

    Jan 17, 2034

    in 7 yr 8 mo

  43. Patent 11337927 expires

    Listed method-of-use patent (U-3226) expiration.

    Jan 17, 2034

    in 7 yr 8 mo

Pharmaceutical detail

Active ingredient

RUXOLITINIB PHOSPHATE

Strength

EQ 11MG BASE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 217180

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents (41)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11744832Dec 12, 2026in 6 mo
U-3226
11744832Dec 12, 2026in 6 mo
U-3230
8530485Dec 12, 2026in 6 mo
Product
9079912Dec 12, 2026in 6 mo
U-3227
9079912Dec 12, 2026in 6 mo
U-3228
9079912Dec 12, 2026in 6 mo
U-3230
9079912Dec 12, 2026in 6 mo
U-3226
9206187Dec 12, 2026in 6 mo
U-3227
9206187Dec 12, 2026in 6 mo
U-3228
9814722Dec 12, 2026in 6 mo
U-3226
9814722Dec 12, 2026in 6 mo
U-3230
7598257Dec 24, 2027in 1 yr 6 mo
SubstanceProductU-3227
7598257Dec 24, 2027in 1 yr 6 mo
SubstanceProductU-3228
8415362Dec 24, 2027in 1 yr 6 mo
SubstanceProduct
10016429Jun 12, 2028in 2 yr
U-3226
10016429Jun 12, 2028in 2 yr
U-3230
11213528Jun 12, 2028in 2 yr
Product
8722693Jun 12, 2028in 2 yr
SubstanceProduct
8822481Jun 12, 2028in 2 yr
U-3227
8822481Jun 12, 2028in 2 yr
U-3228
8822481Jun 12, 2028in 2 yr
U-3230
8822481Jun 12, 2028in 2 yr
U-3226
8829013Jun 12, 2028in 2 yr
U-3227
8829013Jun 12, 2028in 2 yr
U-3228
10874616Nov 14, 2033in 7 yr 6 mo
Product
11576864Nov 14, 2033in 7 yr 6 mo
U-3227
11576864Nov 14, 2033in 7 yr 6 mo
U-3228
11576864Nov 14, 2033in 7 yr 6 mo
U-3230
11576864Nov 14, 2033in 7 yr 6 mo
U-3226
11576865Nov 14, 2033in 7 yr 6 mo
ProductU-3227
11576865Nov 14, 2033in 7 yr 6 mo
ProductU-3228
11576865Nov 14, 2033in 7 yr 6 mo
ProductU-3230
11576865Nov 14, 2033in 7 yr 6 mo
ProductU-3226
11896717Nov 14, 2033in 7 yr 6 mo
ProductU-3227
11896717Nov 14, 2033in 7 yr 6 mo
ProductU-3228
11896717Nov 14, 2033in 7 yr 6 mo
ProductU-3230
11896717Nov 14, 2033in 7 yr 6 mo
ProductU-3226
11337927Jan 17, 2034in 7 yr 8 mo
U-3227
11337927Jan 17, 2034in 7 yr 8 mo
U-3228
11337927Jan 17, 2034in 7 yr 8 mo
U-3230
11337927Jan 17, 2034in 7 yr 8 mo
U-3226
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