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Last Updated: January 27, 2023

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-three 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 September 22, 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

See drug prices for JAKAFI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JAKAFI
Generic Entry Date for JAKAFI*:
Constraining patent/regulatory exclusivity:
TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
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
Medical College of WisconsinPhase 2
Ohio State University Comprehensive Cancer CenterPhase 2
Telios Pharma, Inc.Phase 1/Phase 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 twenty-one US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JAKAFI is See Plans and Pricing.

This potential generic entry date is based on TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER.

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

Patents protecting JAKAFI

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)

Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA

Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF

Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1 AND/OR JAK2.

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF

Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY

Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF POLYCYTHEMIA VERA

Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS

Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF

Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentyl- propanenitrile
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF POLYCYTHEMIA VERA (PV) IN PATIENTS WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS (MF), INCLUDING PRIMARY MF, POST-POLYCYTHEMIA VERA MF AND POST-ESSENTIAL THROMBOCYTHEMIA MF

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (AGVHD)

FDA Regulatory Exclusivity protecting JAKAFI

TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE (GVHD) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing

ADDITION OF THE INDICATION OF TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR TWO LINES OF SYSTEMIC THERAPY IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER
Exclusivity Expiration: See Plans and Pricing

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 202192-003 Nov 16, 2011 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-005 Nov 16, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0814254
Estimated Expiration: See Plans and Pricing

Canada

Patent: 89663
Estimated Expiration: See Plans and Pricing

China

Patent: 1932582
Estimated Expiration: See Plans and Pricing

Patent: 3524509
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51256
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 151
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140541
Estimated Expiration: See Plans and Pricing

Patent: 0160717
Estimated Expiration: See Plans and Pricing

Patent: 0190385
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 933
Estimated Expiration: See Plans and Pricing

Patent: 179
Estimated Expiration: See Plans and Pricing

Patent: 090213
Estimated Expiration: See Plans and Pricing

Patent: 120155
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15145
Estimated Expiration: See Plans and Pricing

Patent: 17693
Estimated Expiration: See Plans and Pricing

Patent: 21338
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 73752
Estimated Expiration: See Plans and Pricing

Patent: 40731
Estimated Expiration: See Plans and Pricing

Patent: 70090
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 009000280
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 099802
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9784
Estimated Expiration: See Plans and Pricing

Patent: 1070013
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 73752
Estimated Expiration: See Plans and Pricing

Patent: 40731
Estimated Expiration: See Plans and Pricing

Patent: 70090
Estimated Expiration: See Plans and Pricing

Patent: 95369
Estimated Expiration: See Plans and Pricing

Patent: 11883
Estimated Expiration: See Plans and Pricing

Finland

Patent: 73752
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0125533
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0900314
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 43161
Estimated Expiration: See Plans and Pricing

Patent: 98652
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29236
Estimated Expiration: See Plans and Pricing

Patent: 43732
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2524
Estimated Expiration: See Plans and Pricing

Patent: 2410
Estimated Expiration: See Plans and Pricing

Patent: 4276
Estimated Expiration: See Plans and Pricing

Patent: 0401
Estimated Expiration: See Plans and Pricing

Patent: 7708
Estimated Expiration: See Plans and Pricing

Japan

Patent: 75653
Estimated Expiration: See Plans and Pricing

Patent: 10529209
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 70090
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4969
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2814
Estimated Expiration: See Plans and Pricing

Patent: 09013402
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 960
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 517
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1803
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0900216
Estimated Expiration: See Plans and Pricing

Norway

Patent: 19025
Estimated Expiration: See Plans and Pricing

Poland

Patent: 73752
Estimated Expiration: See Plans and Pricing

Patent: 40731
Estimated Expiration: See Plans and Pricing

Patent: 70090
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 73752
Estimated Expiration: See Plans and Pricing

Patent: 70090
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 201000002
Estimated Expiration: See Plans and Pricing

Patent: 01000002
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 245
Estimated Expiration: See Plans and Pricing

Patent: 878
Estimated Expiration: See Plans and Pricing

Patent: 449
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2198
Estimated Expiration: See Plans and Pricing

Patent: 201509887U
Estimated Expiration: See Plans and Pricing

Patent: 201912675V
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 73752
Estimated Expiration: See Plans and Pricing

Patent: 40731
Estimated Expiration: See Plans and Pricing

Patent: 70090
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0908826
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1549876
Estimated Expiration: See Plans and Pricing

Patent: 100049010
Estimated Expiration: See Plans and Pricing

Patent: 150036210
Estimated Expiration: See Plans and Pricing

Spain

Patent: 67665
Estimated Expiration: See Plans and Pricing

Patent: 75797
Estimated Expiration: See Plans and Pricing

Patent: 14092
Estimated Expiration: See Plans and Pricing

Patent: 03444
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 09000514
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1903488
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 467
Estimated Expiration: See Plans and Pricing

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
Hong Kong 1124840 HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3- B]PYRIMIDINES AS JANUS KINASE INHIBITORS See Plans and Pricing
Eurasian Patent Organization 201070013 СОЛИ ИНГИБИТОРА ЯНУС-КИНАЗЫ (R)-3-(4-(7H-ПИРРОЛО[2,3-d]ПИРИМИДИН-4-ИЛ)-1H-ПИРАЗОЛ-1-ИЛ)-3-ЦИКЛОПЕНТИЛПРОПАННИТРИЛА See Plans and Pricing
Slovenia 2426129 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JAKAFI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1966202 8/2013 Austria See Plans and Pricing PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2455382 17C1013 France See Plans and Pricing PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
1966202 92137 Luxembourg See Plans and Pricing PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Johnson and Johnson
Mallinckrodt
Medtronic
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.