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Last Updated: June 13, 2025

JAKAFI Drug Patent Profile


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Which patents cover Jakafi, and what generic alternatives are available?

Jakafi is a drug marketed by Incyte Corp and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-five patent family members in forty-six countries.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ruxolitinib phosphate profile page.

DrugPatentWatch® Generic Entry Outlook for Jakafi

Jakafi was eligible for patent challenges on November 16, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 12, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for JAKAFI
Drug Prices for JAKAFI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JAKAFI
Generic Entry Date for JAKAFI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JAKAFI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
City of Hope Medical CenterPhase 2
Washington University School of MedicinePhase 1
Karyopharm Therapeutics IncPhase 2

See all JAKAFI clinical trials

Pharmacology for JAKAFI
Paragraph IV (Patent) Challenges for JAKAFI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JAKAFI Tablets ruxolitinib phosphate 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg 202192 1 2015-12-17

US Patents and Regulatory Information for JAKAFI

JAKAFI is protected by eight US patents and eight FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JAKAFI is ⤷  Try for Free.

This potential generic entry date is based on patent ⤷  Try for Free.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-005 Nov 16, 2011 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for JAKAFI

When does loss-of-exclusivity occur for JAKAFI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08266183
Patent: Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 0814254
Patent: SAIS DO INIBIDOR DE JANUS QUINASE(R)-3(-4(7H-PIRROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZ OL-1-IL)-3-CICLOPENTILPROPANONITRILA
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 89663
Patent: SELS DE L'INHIBITEUR (7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZ OL-1-YL)-3-CYCLOPENTYLPROPANENITRILE DE LA JANUS KINASE (SALTS OF THE JANUS KINASE INHIBITOR (7H-PYRROLO[2,3-D]PYRIMIDIN -4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

China

Patent: 1932582
Patent: Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Estimated Expiration: ⤷  Try for Free

Patent: 3524509
Patent: Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 51256
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRIMIDIN-4IL)1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Costa Rica

Patent: 151
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Croatia

Patent: 0140541
Estimated Expiration: ⤷  Try for Free

Patent: 0160717
Estimated Expiration: ⤷  Try for Free

Patent: 0190385
Estimated Expiration: ⤷  Try for Free

Cuba

Patent: 933
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Patent: 179
Patent: SALES DE ÁCIDO MALEICO Y DE ÁCIDO SULFÚRICO DE (R)-3-(4-(7H-PIRROLO[2,3-d]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Patent: 090213
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Patent: 120155
Patent: SALES DE ÁCIDO MALEICO Y DE ÁCIDO SULFÚRICO DE (R)-3-(4-(7H-PIRROLO[2,3-d]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 15145
Estimated Expiration: ⤷  Try for Free

Patent: 17693
Estimated Expiration: ⤷  Try for Free

Patent: 21338
Estimated Expiration: ⤷  Try for Free

Denmark

Patent: 73752
Estimated Expiration: ⤷  Try for Free

Patent: 40731
Estimated Expiration: ⤷  Try for Free

Patent: 70090
Estimated Expiration: ⤷  Try for Free

Dominican Republic

Patent: 009000280
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 099802
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-d]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3- CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 9784
Patent: СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-d]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 1070013
Patent: СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 73752
Patent: SELS DE L'INHIBITEUR (R)-3-(4-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE DE LA JANUS KINASE (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 40731
Patent: Sels cristallines de l'inhibiteur de janus kinase (r)-3-(4- (7h-pyrrolo [2,3-d] pyrimidin-4-yl)-1h-pyrazol-1-yl) -3-cyclopentylpropanenitrile (CRYSTALLINE SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 70090
Patent: UTILISATION DES SELS DE L'INHIBITEUR DE JANUS KINASE (R)-3-(4- (7H-PYRROLO [2,3-D] PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL) -3-CYCLOPENTYLPROPANENITRILE (USE OF SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3- CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 95369
Patent: UTILISATION DES SELS DE L'INHIBITEUR DE JANUS KINASE (R)-3-(4-(7H-PYRROLO [2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE (USE OF SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3- CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 11883
Patent: SELS DE L'INHIBITEUR DE JANUS KINASE (R)-3-(4-(7H-PYRROLO[2,3-D -1H-]PYRIMIDINE-4-YL) -1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Georgia, Republic of

Patent: 0125533
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYL PROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Guatemala

Patent: 0900314
Patent: SALES DEL INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO [2,3-D] PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 43161
Patent: 激酶抑制劑 -吡咯 嘧啶- -基 -吡唑- -基 -環戊基丙腈的鹽 (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4- YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE JANUS (R)-3-(4-(7H-[23-D]-4-)-1H--1-)-3-)
Estimated Expiration: ⤷  Try for Free

Patent: 98652
Patent: 激酶抑制劑 -吡咯 嘧啶- -基 -吡唑- -基 -環戊基丙腈的結晶鹽 (CRYSTALLINE SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3- D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE JANUS (R)-3-(4-(7H-[23-D]-4-)-1H--1-)-3-)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 29236
Estimated Expiration: ⤷  Try for Free

Patent: 43732
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 2524
Patent: מלחים של מדכא ג'אנוס קינאס (r)-3- (4-(7h-פירולו[d-3, 2]פירימידין -4-איל)-h 1-פיראזול-1-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7 h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile)
Estimated Expiration: ⤷  Try for Free

Patent: 4276
Patent: מלחים של מדכא ג'אנוס קינאס (r)- 3- (4-(h7-פירולו[d - 2,3]פירימידין-4-איל)-1h-פיראזול-1l-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-)
Estimated Expiration: ⤷  Try for Free

Patent: 0401
Patent: מלחים של מדכא ג'אנוס קינאס (r)- 3- (4-(h7-פירולו[d - 2,3]פירימידין-4-איל)-1h-פיראזול-1l-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile)
Estimated Expiration: ⤷  Try for Free

Patent: 7708
Patent: מלחים של מדכא ג'אנוס קינאס (r)- 3- (4-(h7-פירולו[d - 2,3]פירימידין-4-איל)-1h-פיראזול-1l-איל)-3-ציקלופנטילפרופאנאניטריל (Salts of the janus kinase inhibitor (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 75653
Estimated Expiration: ⤷  Try for Free

Patent: 10529209
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 70090
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 4969
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 2814
Patent: SALES DE INHIBIDOR DE JANUS CINASA (R)-3-(4-7H-PIRROLO[2,3-D]PIRIM IDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO. (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PY RIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE.)
Estimated Expiration: ⤷  Try for Free

Patent: 09013402
Patent: SALES DE INHIBIDOR DE JANUS CINASA (R)-3-(4-(7H-PIRROLO[2,3-D]PIRI MIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CICLOPENTILPROPANITRILO. (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PY RIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE.)
Estimated Expiration: ⤷  Try for Free

Montenegro

Patent: 960
Patent: SOLI INHIBITORA JANUS KINAZE, (R)-3-(4-(7H-PIROL[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPANNITRILA (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 517
Patent: املاح المثبط (r)-3-(4-(7h-البيرولو(3،2- d)بيرميدين-4- yl)- 1h-بيرازول-1- yl)-3_ سيكلوبينتيلبروباننيتريل من يانوس الكيناز.
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 1803
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Nicaragua

Patent: 0900216
Patent: SALES DE INHIBIDOR DE JANUS CINASA ( R ) - ( 3 ) - ( 4 - ( 7H - PIRROLO [ 2,3-D ] PIRIMIDIN - 4 - IL ) - 1H - PIRAZOL - 1 - IL) - 3 - CICLOPENTILPROPANENITRILO.
Estimated Expiration: ⤷  Try for Free

Norway

Patent: 19025
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 73752
Estimated Expiration: ⤷  Try for Free

Patent: 40731
Estimated Expiration: ⤷  Try for Free

Patent: 70090
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 73752
Estimated Expiration: ⤷  Try for Free

Patent: 70090
Estimated Expiration: ⤷  Try for Free

San Marino

Patent: 201000002
Patent: Sali dell'inibitore di chinasi janus (r)-3-(4-(7h-pirrolo[2,3-d]pirimidin-4-il)-1h-pirazoli-1-il)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷  Try for Free

Patent: 01000002
Patent: Sali dell'inibitore di chinasi janus (R)-3-(4-(7H-pirrolo[2,3-D]pirimidin-4-IL)-1H-pirazoli-1-IL)-3-ciclopentilpropanonitrile
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 245
Patent: SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO(2,3-D) PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPAN-NITRILA (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 878
Patent: KRISTALNE SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H-PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRIL (CRYSTALLINE SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Patent: 449
Patent: UPOTREBA SOLI INHIBITORA JANUS KINAZE (R)-3-(4-(7H-PIROLO[2,3-D]PIRIMIDIN-4-IL)-1H- PIRAZOL-1-IL)-3-CIKLOPENTILPROPIONITRILA (USE OF SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H- PYRAZOL-1-YL)-3- CYCLOPENTYLPROPANENITRILE)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 2198
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Patent: 201509887U
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Patent: 201912675V
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 73752
Estimated Expiration: ⤷  Try for Free

Patent: 40731
Estimated Expiration: ⤷  Try for Free

Patent: 70090
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 0908826
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTHYLPROPANEITRILE
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 1549876
Estimated Expiration: ⤷  Try for Free

Patent: 100049010
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Patent: 150036210
Patent: 야누스 키나제 억제제(R)―3―(4―(7H―피롤로[2,3-d]피리미딘―4―일)―1H―피라졸―1―일)―3―사이클로펜틸프로판니트릴의 염 (Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile)
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 67665
Estimated Expiration: ⤷  Try for Free

Patent: 75797
Estimated Expiration: ⤷  Try for Free

Patent: 14092
Estimated Expiration: ⤷  Try for Free

Patent: 03444
Estimated Expiration: ⤷  Try for Free

Tunisia

Patent: 09000514
Patent: SALTS OF THE JANUS KINASE INHIBITOR (R) -3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE
Estimated Expiration: ⤷  Try for Free

Turkey

Patent: 1903488
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 467
Patent: СОЛІ ІНГІБІТОРА ЯНУС-КІНАЗИ (R)-3-(4-(7H-ПІРОЛО[2,3-d]ПІРИМІДИН-4-ІЛ)-1H-ПІРАЗОЛ-1-ІЛ)-3-ЦИКЛОПЕНТИЛПРОПАННІТРИЛУ[СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА (SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-d]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTYLPROPANENITRILE)
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JAKAFI around the world.

Country Patent Number Title Estimated Expiration
Denmark 2348023 ⤷  Try for Free
Spain 2467665 ⤷  Try for Free
Cyprus 1118506 ⤷  Try for Free
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Supplementary Protection Certificates for JAKAFI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1966202 92137 Luxembourg ⤷  Try for Free PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1966202 122013000015 Germany ⤷  Try for Free PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202 C01966202/01 Switzerland ⤷  Try for Free FORMER OWNER: INCYTE CORPORATION, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for JAKAFI

Introduction

JAKAFI (ruxolitinib), developed by Incyte, is a Janus kinase (JAK) inhibitor that has been a cornerstone in the treatment of various hematological disorders, including myelofibrosis, polycythemia vera, and graft-versus-host disease. Here, we delve into the market dynamics and financial trajectory of JAKAFI, examining its performance, competitive landscape, and future outlook.

Market Performance of JAKAFI

Quarterly Revenue Growth

In the fourth quarter of 2023, Incyte achieved a significant milestone with JAKAFI, crossing the $1 billion threshold in quarterly revenues for the first time. JAKAFI generated $695 million in sales, although this was slightly below analysts' expectations. However, the drug still demonstrated a 7% year-over-year growth[1].

In the third quarter of 2024, JAKAFI continued to show strong performance, with net product revenues of $741 million, representing a 16% year-over-year increase. This growth was driven by increased patient demand across all indications[2].

Annual Sales Projections

Incyte projects JAKAFI sales to grow from $2.59 billion in 2023 to a range between $2.69 billion and $2.75 billion in 2024. The company is optimistic about reaching its target of $3 billion in sales by 2028, partly due to the anticipated impact of the new $2,000 out-of-pocket cap for Medicare Part D under the Inflation Reduction Act[1].

Competitive Landscape

Entry of New JAK Inhibitors

The market for JAK inhibitors is becoming increasingly competitive with the launch of new drugs. GSK's Ojjaara, approved for anemic myelofibrosis, is a significant competitor. Despite Ojjaara's strong uptake, with 750 patients and a 15% share in the anemic population, JAKAFI maintained around 53-54% of the total myelofibrosis market share and 60-63% of new patient share from September to December 2023[1].

Other competitors include Bristol Myers Squibb’s Inrebic and CTI BioPharma’s Vonjo, though these have had minimal impact on JAKAFI's market share and sales[4].

Differentiation and Market Position

JAKAFI remains the only drug to have shown superior overall survival in myelofibrosis, regardless of the patient’s anemia status. This strong designation gives Incyte confidence in maintaining its leadership in the myelofibrosis market. Additionally, JAKAFI's label has no line restrictions or anemia status requirements, which is a significant advantage over competitors like Ojjaara[4].

Financial Impact of Competitive Dynamics

Revenue and Market Share

Despite the entry of new competitors, JAKAFI has continued to generate substantial revenue. The drug's resilience is attributed to its established market presence and the lack of significant market share erosion by new entrants. For instance, in the third quarter of 2024, JAKAFI's net product revenues grew by 16%, driven by increased patient demand[2].

Operating Expenses and Profitability

Incyte's financial performance is closely tied to JAKAFI's sales. For the third quarter of 2024, Incyte reported total GAAP revenues of $1.137 billion, with a GAAP operating income of $146 million. Non-GAAP operating income was $255 million, reflecting the company's ability to maintain profitability despite increasing competition[2].

Future Outlook and Strategies

Addressing Patent Cliff

JAKAFI faces a patent cliff in 2028, which poses a significant challenge. Incyte is working on several strategies to mitigate this impact, including the development of an extended-release version of JAKAFI, although this was recently rejected by the FDA. The company is addressing the FDA's concerns and is confident in resolving them before the patent cliff[4].

Expanding Indications

Incyte is also focusing on expanding JAKAFI's indications. For example, recent clinical data showed that JAKAFI reduced the risk of major thrombosis by 44% in patients with polycythemia vera who cannot take hydroxycarbamide. This new indication is expected to be a key growth driver for the drug[4].

Novel Combinations

The company is exploring novel combinations involving JAKAFI, such as monotherapy and combination data for its ALK2 inhibitor zilurgisertib and BET inhibitor INCB57643. These efforts aim to enhance JAKAFI's therapeutic profile and maintain its market dominance[4].

Regulatory and Policy Impact

Medicare Part D Changes

The new $2,000 out-of-pocket cap for Medicare Part D, set to go into effect in 2025 under the Inflation Reduction Act, is expected to positively impact JAKAFI sales. This policy change could encourage patients who previously could not afford the drug to opt into JAKAFI therapy, thereby increasing its market reach[1].

Key Takeaways

  • Revenue Growth: JAKAFI has consistently shown year-over-year revenue growth, despite facing competition from new JAK inhibitors.
  • Market Share: JAKAFI maintains a significant market share in myelofibrosis, with around 53-54% of the total market and 60-63% of new patient share.
  • Competitive Landscape: New competitors like GSK's Ojjaara pose a threat, but JAKAFI's superior overall survival benefit and lack of line restrictions or anemia status requirements maintain its market leadership.
  • Future Strategies: Incyte is focusing on expanding indications, developing novel combinations, and addressing the upcoming patent cliff to ensure JAKAFI's continued success.
  • Regulatory Impact: Changes in Medicare Part D policies are expected to boost JAKAFI sales by making the drug more affordable for patients.

FAQs

Q: What are the current sales projections for JAKAFI in 2024?

A: Incyte projects JAKAFI sales to grow from $2.59 billion in 2023 to a range between $2.69 billion and $2.75 billion in 2024[1].

Q: How is JAKAFI performing against new competitors like GSK's Ojjaara?

A: Despite the entry of Ojjaara, JAKAFI has maintained around 53-54% of the total myelofibrosis market share and 60-63% of new patient share from September to December 2023[1].

Q: What strategies is Incyte employing to address the patent cliff for JAKAFI in 2028?

A: Incyte is working on developing an extended-release version of JAKAFI, expanding its indications, and exploring novel combinations to mitigate the impact of the patent cliff[4].

Q: How will the new Medicare Part D policy impact JAKAFI sales?

A: The new $2,000 out-of-pocket cap for Medicare Part D is expected to make JAKAFI more affordable, potentially increasing sales as more patients opt into the therapy[1].

Q: What are the key growth drivers for JAKAFI in the future?

A: The key growth drivers include expanding indications, such as polycythemia vera, and the potential impact of the new Medicare Part D policy[4].

Sources

  1. FiercePharma: "Amid GSK showdown, Incyte crosses $1B in quarterly revenue"
  2. Incyte Investor Relations: "Incyte Reports 2024 Third Quarter Financial Results and Provides"
  3. GlobeNewswire: "JAKAFI (Ruxolitinib) Emerging Drug Insights and Market Forecasts - 2032"
  4. FiercePharma: "Battling new rivals and bracing for Jakafi's patent cliff, Incyte shores up resilience with new disease and combo strategies"
Last updated: 2024-12-16

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