You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 24, 2024

~ Buy the JAKAFI (ruxolitinib phosphate) Drug Profile, 2024 PDF Report in the Report Store ~

JAKAFI Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 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

< Available with Subscription >

  Try a Trial

Drug patent expirations by year for JAKAFI
Drug Prices for JAKAFI

See drug prices for JAKAFI

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
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 eight US patents and eight FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

REVISIONS TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULTS OF STUDY INCB 18424-269
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-002 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-003 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Incyte Corp JAKAFI ruxolitinib phosphate TABLET;ORAL 202192-004 Nov 16, 2011 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 0814254
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 89663
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1932582
Estimated Expiration: ⤷  Try a Trial

Patent: 3524509
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51256
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 151
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0140541
Estimated Expiration: ⤷  Try a Trial

Patent: 0160717
Estimated Expiration: ⤷  Try a Trial

Patent: 0190385
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 933
Estimated Expiration: ⤷  Try a Trial

Patent: 179
Estimated Expiration: ⤷  Try a Trial

Patent: 090213
Estimated Expiration: ⤷  Try a Trial

Patent: 120155
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15145
Estimated Expiration: ⤷  Try a Trial

Patent: 17693
Estimated Expiration: ⤷  Try a Trial

Patent: 21338
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 73752
Estimated Expiration: ⤷  Try a Trial

Patent: 40731
Estimated Expiration: ⤷  Try a Trial

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 009000280
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 099802
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9784
Estimated Expiration: ⤷  Try a Trial

Patent: 1070013
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 73752
Estimated Expiration: ⤷  Try a Trial

Patent: 40731
Estimated Expiration: ⤷  Try a Trial

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

Patent: 95369
Estimated Expiration: ⤷  Try a Trial

Patent: 11883
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0125533
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0900314
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 43161
Estimated Expiration: ⤷  Try a Trial

Patent: 98652
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 29236
Estimated Expiration: ⤷  Try a Trial

Patent: 43732
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2524
Estimated Expiration: ⤷  Try a Trial

Patent: 4276
Estimated Expiration: ⤷  Try a Trial

Patent: 0401
Estimated Expiration: ⤷  Try a Trial

Patent: 7708
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 75653
Estimated Expiration: ⤷  Try a Trial

Patent: 10529209
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4969
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2814
Estimated Expiration: ⤷  Try a Trial

Patent: 09013402
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 960
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 517
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1803
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0900216
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 19025
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 73752
Estimated Expiration: ⤷  Try a Trial

Patent: 40731
Estimated Expiration: ⤷  Try a Trial

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 73752
Estimated Expiration: ⤷  Try a Trial

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 201000002
Estimated Expiration: ⤷  Try a Trial

Patent: 01000002
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 245
Estimated Expiration: ⤷  Try a Trial

Patent: 878
Estimated Expiration: ⤷  Try a Trial

Patent: 449
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 2198
Estimated Expiration: ⤷  Try a Trial

Patent: 201509887U
Estimated Expiration: ⤷  Try a Trial

Patent: 201912675V
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 73752
Estimated Expiration: ⤷  Try a Trial

Patent: 40731
Estimated Expiration: ⤷  Try a Trial

Patent: 70090
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0908826
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1549876
Estimated Expiration: ⤷  Try a Trial

Patent: 100049010
Estimated Expiration: ⤷  Try a Trial

Patent: 150036210
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 67665
Estimated Expiration: ⤷  Try a Trial

Patent: 75797
Estimated Expiration: ⤷  Try a Trial

Patent: 14092
Estimated Expiration: ⤷  Try a Trial

Patent: 03444
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 09000514
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1903488
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 467
Estimated Expiration: ⤷  Try a Trial

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
Montenegro 01312 HETEROARIL SUPSTITUIRANI PIROL0[2,3-B]PIRIDINI I PIROL0 [ 2,3-B]PIRIMIDINI KAO INHIBITORI JANUS KINAZE (HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3-B]PYRIMIDINES AS JANUS KINASE INHIBITORS) ⤷  Try a Trial
Singapore 10202003901U HETEROARYL SUBSTITUTED PYRROLO[2,3-B]PYRIDINES AND PYRROLO[2,3-B]PYRIMIDINES AS JANUS KINASE INHIBITORS ⤷  Try a Trial
Croatia P20160717 ⤷  Try a Trial
Denmark 2455382 ⤷  Try a Trial
European Patent Office 2343298 Pyrrolo[2,3-b]pyrimidines et pyrrolo[2,3-b]pyridines substituées par des groupements hétéroaryle en tant qu'inhibiteurs de kinase Janus (Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors) ⤷  Try a Trial
Serbia 54878 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) ⤷  Try a Trial
European Patent Office 2474545 Pyrrolo[2,3-b]pyridines et pyrrolo[2,3-b]pyrimidines à substitution hétéroaryle en tant qu'inhibiteurs de la janus kinase (Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JAKAFI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2455382 132017000044713 Italy ⤷  Try a Trial PRODUCT NAME: RUXOLITINIB, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(JAKAVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/773/001-016, 20150313
1966202 C01966202/01 Switzerland ⤷  Try a Trial FORMER OWNER: INCYTE CORPORATION, US
1966202 PA2013002,C1966202 Lithuania ⤷  Try a Trial PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
1966202 448 Finland ⤷  Try a Trial
1966202 2013C/014 Belgium ⤷  Try a Trial PRODUCT NAME: RUXOLITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001 20120828
1966202 PA2013002 Lithuania ⤷  Try a Trial
2455382 CA 2017 00018 Denmark ⤷  Try a Trial PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: C(2015)1740/EU/1/12/773/001-016 20150313
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.