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Orange Book drug · Brand (NDA)

Jakafi

Ruxolitinib Phosphate

RLDNDA 202192 5 strengths Incyte Corp
Approved
Nov 16, 2011
Strengths
5
Listed patents
16

What does the FDA Orange Book show for Jakafi?

Jakafi contains Ruxolitinib Phosphate and is the new drug FDA Orange Book record for NDA 202192. 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 202192

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
16

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

Exclusivity records
6

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 5MG BASETABLETORALPrescriptionNone posted
RLD
002EQ 10MG BASETABLETORALPrescriptionNone posted
RLD
003EQ 15MG BASETABLETORALPrescriptionNone posted
RLD
004EQ 20MG BASETABLETORALPrescriptionNone posted
RLD
005EQ 25MG BASETABLETORALPrescriptionNone 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 202192.

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

16 listed patent expirations and 3 exclusivity dates remain on or after Jul 26, 2026

The latest future date recorded across those files is Mar 22, 2029. 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 202192 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 · 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-202192

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 202192
RLD
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    14 yr 11 mo ago

  2. Exclusivity ends · M-285

    New use / labeling-change exclusivity (3 years)

    7 mo ago

  3. Exclusivity ends · ODE-238

    Orphan-drug exclusivity (7 years)

    2 mo ago

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    1 mo ago

  5. Today

  6. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 4 mo

  7. Patent 9079912 expires

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

    in 5 mo

  8. Patent 9079912 expires

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

    in 5 mo

  9. Patent 9079912 expires

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

    in 5 mo

  10. Patent 9079912 expires

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

    in 5 mo

  11. Patent 9814722 expires

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

    in 5 mo

  12. Patent 9814722 expires

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

    in 5 mo

  13. Patent 9079912*PED expires

    Listed listed patent expiration.

    in 11 mo

  14. Patent 9814722*PED expires

    Listed listed patent expiration.

    in 11 mo

  15. Patent 7598257 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  16. Patent 7598257 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  17. Patent 8415362 expires

    Listed drug substance patent expiration.

    in 1 yr 5 mo

  18. Patent 10016429 expires

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

    in 1 yr 11 mo

  19. Patent 10016429 expires

    Listed method-of-use patent (U-3230) 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-1573) expiration.

    in 1 yr 11 mo

  22. Patent 8822481 expires

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

    in 1 yr 11 mo

  23. Patent 8822481 expires

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

    in 1 yr 11 mo

  24. Patent 8822481 expires

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

    in 1 yr 11 mo

  25. Patent 8822481 expires

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

    in 1 yr 11 mo

  26. Patent 8829013 expires

    Listed method-of-use patent (U-1622) expiration.

    in 1 yr 11 mo

  27. Patent 8829013 expires

    Listed method-of-use patent (U-1201) expiration.

    in 1 yr 11 mo

  28. Patent 8829013 expires

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

    in 1 yr 11 mo

  29. Patent 8829013 expires

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

    in 1 yr 11 mo

  30. Patent 7598257*PED expires

    Listed listed patent expiration.

    in 1 yr 11 mo

  31. Patent 8415362*PED expires

    Listed listed patent expiration.

    in 1 yr 11 mo

  32. Exclusivity ends · ODE-373

    Orphan-drug exclusivity (7 years)

    in 2 yr 2 mo

  33. Patent 10016429*PED expires

    Listed listed patent expiration.

    in 2 yr 5 mo

  34. Patent 8722693*PED expires

    Listed listed patent expiration.

    in 2 yr 5 mo

  35. Patent 8822481*PED expires

    Listed listed patent expiration.

    in 2 yr 5 mo

  36. Patent 8829013*PED expires

    Listed listed patent expiration.

    in 2 yr 5 mo

  37. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    in 2 yr 8 mo

Patent & exclusivity timeline

Protection horizon
202520262027202820292030TodayExclusivity M-285: 2025-12-19Exclusivity M-285Exclusivity ODE-238: 2026-05-24Exclusivity ODE-238Exclusivity PED: 2026-06-19Exclusivity PEDExclusivity PED: 2026-11-24Exclusivity PEDPatent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9079912: 2026-12-12Patent 9079912Patent 9814722: 2026-12-12Patent 9814722Patent 9814722: 2026-12-12Patent 9814722Patent 9079912*PED: 2027-06-12Patent 9079912*PEDPatent 9814722*PED: 2027-06-12Patent 9814722*PEDPatent 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 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 8822481: 2028-06-12Patent 8822481Patent 8829013: 2028-06-12Patent 8829013Patent 8829013: 2028-06-12Patent 8829013Patent 8829013: 2028-06-12Patent 8829013Patent 8829013: 2028-06-12Patent 8829013Patent 7598257*PED: 2028-06-24Patent 7598257*PEDPatent 8415362*PED: 2028-06-24Patent 8415362*PEDExclusivity ODE-373: 2028-09-22Exclusivity ODE-373Patent 10016429*PED: 2028-12-12Patent 10016429*PEDPatent 8722693*PED: 2028-12-12Patent 8722693*PEDPatent 8822481*PED: 2028-12-12Patent 8822481*PEDPatent 8829013*PED: 2028-12-12Patent 8829013*PEDExclusivity PED: 2029-03-22Exclusivity PED
Patent expiryExclusivity endToday

Pharmaceutical detail

FDA product record

Active ingredient

RUXOLITINIB PHOSPHATE

Strength

EQ 5MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 202192

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Marketing exclusivity

Hatch-Waxman
  • M-285New use / labeling-change exclusivity (3 years)

    7 mo ago

  • ODE-238Orphan-drug exclusivity (7 years)

    2 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    1 mo ago

  • PEDPediatric exclusivity (adds 6 months)

    in 4 mo

  • ODE-373Orphan-drug exclusivity (7 years)

    in 2 yr 2 mo

  • PEDPediatric exclusivity (adds 6 months)

    in 2 yr 8 mo

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9079912in 5 mo
U-3226
9079912in 5 mo
U-3228
9079912in 5 mo
U-3227
9079912in 5 mo
U-3230
9814722in 5 mo
U-3226
9814722in 5 mo
U-3230
9079912*PEDin 11 mo
9814722*PEDin 11 mo
7598257in 1 yr 5 mo
SubstanceProductU-3228
7598257in 1 yr 5 mo
SubstanceProductU-3227
8415362in 1 yr 5 mo
SubstanceProduct
10016429in 1 yr 11 mo
U-3226
10016429in 1 yr 11 mo
U-3230
8722693in 1 yr 11 mo
SubstanceProduct
8822481in 1 yr 11 mo
U-1573
8822481in 1 yr 11 mo
U-3226
8822481in 1 yr 11 mo
U-3228
8822481in 1 yr 11 mo
U-3227
8822481in 1 yr 11 mo
U-3230
8829013in 1 yr 11 mo
U-1622
8829013in 1 yr 11 mo
U-1201
8829013in 1 yr 11 mo
U-3227
8829013in 1 yr 11 mo
U-3228
7598257*PEDin 1 yr 11 mo
8415362*PEDin 1 yr 11 mo
10016429*PEDin 2 yr 5 mo
8722693*PEDin 2 yr 5 mo
8822481*PEDin 2 yr 5 mo
8829013*PEDin 2 yr 5 mo

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: 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 202192 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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