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Orange Book drug · Brand (NDA)

Jakafi XR

Ruxolitinib Phosphate

RLDNDA 217180 5 strengths Incyte Corp
Approved
May 01, 2026
Strengths
5
Listed patents
17

What does the FDA Orange Book show for Jakafi XR?

Jakafi XR contains Ruxolitinib Phosphate and is the new drug FDA Orange Book record for NDA 217180. The application has 5 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 217180

New drug application identity from the Orange Book snapshot.

Application holder
Incyte Corp

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
5

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
None posted

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
17

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
001EQ 11MG BASETABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
002EQ 22MG BASETABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
003EQ 33MG BASETABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
004EQ 44MG BASETABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLD
005EQ 55MG BASETABLET, EXTENDED RELEASEORALPrescriptionNone posted
RLDRS

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

Incyte Corp

The Orange Book identifies this organization as the applicant responsible for NDA 217180.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

5 presentations listed as prescription

RX and OTC are Orange Book marketing categories, not real-time inventory signals. Confirm current commercial availability with labeling, the application holder, or an authoritative drug listing.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no code.

Patent & exclusivity record

17 listed patent expirations and 0 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Jan 17, 2034. Patent and FDA exclusivity operate independently, can overlap, and do not by themselves predict a generic launch date.

Same-ingredient landscape

0 other ANDAs and 2 other NDAs found

0 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 217180 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Tablet, Extended Release · Oral

Ruxolitinib Phosphate

1 application
Product rows
5
Active applications
1
Active with AB row
0

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-217180

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

5 approved presentations · NDA 217180
RLD
Strength
EQ 11MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    3 mo ago

  2. Today

  3. Patent 11744832 expires

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

    in 5 mo

  4. Patent 11744832 expires

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

    in 5 mo

  5. Patent 8530485 expires

    Listed drug product patent expiration.

    in 5 mo

  6. Patent 9079912 expires

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

    in 5 mo

  7. Patent 9079912 expires

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

    in 5 mo

  8. Patent 9079912 expires

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

    in 5 mo

  9. Patent 9079912 expires

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

    in 5 mo

  10. Patent 9206187 expires

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

    in 5 mo

  11. Patent 9206187 expires

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

    in 5 mo

  12. Patent 9814722 expires

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

    in 5 mo

  13. Patent 9814722 expires

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

    in 5 mo

  14. Patent 7598257 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  15. Patent 7598257 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  16. Patent 8415362 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  17. Patent 10016429 expires

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

    in 1 yr 11 mo

  18. Patent 10016429 expires

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

    in 1 yr 11 mo

  19. Patent 11213528 expires

    Listed drug product patent expiration.

    in 1 yr 11 mo

  20. Patent 8722693 expires

    Listed drug substance patent expiration.

    in 1 yr 11 mo

  21. Patent 8822481 expires

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

    in 1 yr 11 mo

  22. Patent 8822481 expires

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

    in 1 yr 11 mo

  23. Patent 8822481 expires

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

    in 1 yr 11 mo

  24. Patent 8822481 expires

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

    in 1 yr 11 mo

  25. Patent 8829013 expires

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

    in 1 yr 11 mo

  26. Patent 8829013 expires

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

    in 1 yr 11 mo

  27. Patent 10874616 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  28. Patent 11576864 expires

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

    in 7 yr 5 mo

  29. Patent 11576864 expires

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

    in 7 yr 5 mo

  30. Patent 11576864 expires

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

    in 7 yr 5 mo

  31. Patent 11576864 expires

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

    in 7 yr 5 mo

  32. Patent 11576865 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  33. Patent 11576865 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  34. Patent 11576865 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  35. Patent 11576865 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  36. Patent 11896717 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  37. Patent 11896717 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  38. Patent 11896717 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  39. Patent 11896717 expires

    Listed drug product patent expiration.

    in 7 yr 5 mo

  40. Patent 11337927 expires

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

    in 7 yr 7 mo

  41. Patent 11337927 expires

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

    in 7 yr 7 mo

  42. Patent 11337927 expires

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

    in 7 yr 7 mo

  43. Patent 11337927 expires

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

    in 7 yr 7 mo

Patent & exclusivity timeline

Protection horizon
2026202720282029203020312032203320342035TodayPatent 11744832: 2026-12-12Patent 11744832Patent 11744832: 2026-12-12Patent 11744832Patent 8530485: 2026-12-12Patent 8530485Patent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9206187: 2026-12-12Patent 9206187Patent 9206187: 2026-12-12Patent 9206187Patent 9814722: 2026-12-12Patent 9814722Patent 9814722: 2026-12-12Patent 9814722Patent 7598257: 2027-12-24Patent 7598257Patent 7598257: 2027-12-24Patent 7598257Patent 8415362: 2027-12-24Patent 8415362Patent 10016429: 2028-06-12Patent 10016429Patent 10016429: 2028-06-12Patent 10016429Patent 11213528: 2028-06-12Patent 11213528Patent 8722693: 2028-06-12Patent 8722693Patent 8822481: 2028-06-12Patent 8822481Patent 8822481: 2028-06-12Patent 8822481Patent 8822481: 2028-06-12Patent 8822481Patent 8822481: 2028-06-12Patent 8822481Patent 8829013: 2028-06-12Patent 8829013Patent 8829013: 2028-06-12Patent 8829013Patent 10874616: 2033-11-14Patent 10874616Patent 11576864: 2033-11-14Patent 11576864Patent 11576864: 2033-11-14Patent 11576864Patent 11576864: 2033-11-14Patent 11576864Patent 11576864: 2033-11-14Patent 11576864Patent 11576865: 2033-11-14Patent 11576865Patent 11576865: 2033-11-14Patent 11576865Patent 11576865: 2033-11-14Patent 11576865Patent 11576865: 2033-11-14Patent 11576865Patent 11896717: 2033-11-14Patent 11896717Patent 11896717: 2033-11-14Patent 11896717Patent 11896717: 2033-11-14Patent 11896717Patent 11896717: 2033-11-14Patent 11896717Patent 11337927: 2034-01-17Patent 11337927Patent 11337927: 2034-01-17Patent 11337927Patent 11337927: 2034-01-17Patent 11337927Patent 11337927: 2034-01-17Patent 11337927
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

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

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11744832in 5 mo
U-3226
11744832in 5 mo
U-3230
8530485in 5 mo
Product
9079912in 5 mo
U-3227
9079912in 5 mo
U-3228
9079912in 5 mo
U-3230
9079912in 5 mo
U-3226
9206187in 5 mo
U-3227
9206187in 5 mo
U-3228
9814722in 5 mo
U-3226
9814722in 5 mo
U-3230
7598257in 1 yr 5 mo
SubstanceProductU-3227
7598257in 1 yr 5 mo
SubstanceProductU-3228
8415362in 1 yr 5 mo
SubstanceProduct
10016429in 1 yr 11 mo
U-3226
10016429in 1 yr 11 mo
U-3230
11213528in 1 yr 11 mo
Product
8722693in 1 yr 11 mo
SubstanceProduct
8822481in 1 yr 11 mo
U-3227
8822481in 1 yr 11 mo
U-3228
8822481in 1 yr 11 mo
U-3230
8822481in 1 yr 11 mo
U-3226
8829013in 1 yr 11 mo
U-3227
8829013in 1 yr 11 mo
U-3228
10874616in 7 yr 5 mo
Product
11576864in 7 yr 5 mo
U-3227
11576864in 7 yr 5 mo
U-3228
11576864in 7 yr 5 mo
U-3230
11576864in 7 yr 5 mo
U-3226
11576865in 7 yr 5 mo
ProductU-3227
11576865in 7 yr 5 mo
ProductU-3228
11576865in 7 yr 5 mo
ProductU-3230
11576865in 7 yr 5 mo
ProductU-3226
11896717in 7 yr 5 mo
ProductU-3227
11896717in 7 yr 5 mo
ProductU-3228
11896717in 7 yr 5 mo
ProductU-3230
11896717in 7 yr 5 mo
ProductU-3226
11337927in 7 yr 7 mo
U-3227
11337927in 7 yr 7 mo
U-3228
11337927in 7 yr 7 mo
U-3230
11337927in 7 yr 7 mo
U-3226

Active-ingredient family

Brand + generics

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

View full Ruxolitinib Phosphate family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Jakafi XR: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 217180 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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