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JAKAFI Drug Patent Profile

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When do Jakafi patents expire, and when can generic versions of Jakafi launch?

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

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Summary for JAKAFI

International Patents:	233
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	75
Patent Applications:	514
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JAKAFI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JAKAFI
What excipients (inactive ingredients) are in JAKAFI?	JAKAFI excipients list
DailyMed Link:	JAKAFI at DailyMed

Drug patent expirations by year for JAKAFI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JAKAFI

Generic Entry Date for JAKAFI^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 202192 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

Sponsor	Phase
Medical College of Wisconsin	Phase 2
Ohio State University Comprehensive Cancer Center	Phase 2
Telios Pharma, Inc.	Phase 1/Phase 2

See all JAKAFI clinical trials

Pharmacology for JAKAFI

Drug Class	Janus Kinase Inhibitor Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for JAKAFI

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01EJ	Janus-associated kinase (JAK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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

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: ⤷ Sign Up

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: ⤷ Sign Up

REVISIONS TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULTS OF STUDY INCB 18424-269
Exclusivity Expiration: ⤷ Sign Up

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: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

Brazil

Patent: 0814254
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 89663
Estimated Expiration: ⤷ Sign Up

China

Patent: 1932582
Estimated Expiration: ⤷ Sign Up

Patent: 3524509
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 51256
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 151
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0140541
Estimated Expiration: ⤷ Sign Up

Patent: 0160717
Estimated Expiration: ⤷ Sign Up

Patent: 0190385
Estimated Expiration: ⤷ Sign Up

Cuba

Patent: 933
Estimated Expiration: ⤷ Sign Up

Patent: 179
Estimated Expiration: ⤷ Sign Up

Patent: 090213
Estimated Expiration: ⤷ Sign Up

Patent: 120155
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 15145
Estimated Expiration: ⤷ Sign Up

Patent: 17693
Estimated Expiration: ⤷ Sign Up

Patent: 21338
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 73752
Estimated Expiration: ⤷ Sign Up

Patent: 40731
Estimated Expiration: ⤷ Sign Up

Patent: 70090
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 009000280
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 099802
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 9784
Estimated Expiration: ⤷ Sign Up

Patent: 1070013
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 73752
Estimated Expiration: ⤷ Sign Up

Patent: 40731
Estimated Expiration: ⤷ Sign Up

Patent: 70090
Estimated Expiration: ⤷ Sign Up

Patent: 95369
Estimated Expiration: ⤷ Sign Up

Patent: 11883
Estimated Expiration: ⤷ Sign Up

Georgia, Republic of

Patent: 0125533
Estimated Expiration: ⤷ Sign Up

Guatemala

Patent: 0900314
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 43161
Estimated Expiration: ⤷ Sign Up

Patent: 98652
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 29236
Estimated Expiration: ⤷ Sign Up

Patent: 43732
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 2524
Estimated Expiration: ⤷ Sign Up

Patent: 4276
Estimated Expiration: ⤷ Sign Up

Patent: 0401
Estimated Expiration: ⤷ Sign Up

Patent: 7708
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 75653
Estimated Expiration: ⤷ Sign Up

Patent: 10529209
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 70090
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 4969
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 2814
Estimated Expiration: ⤷ Sign Up

Patent: 09013402
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 960
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 517
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 1803
Estimated Expiration: ⤷ Sign Up

Nicaragua

Patent: 0900216
Estimated Expiration: ⤷ Sign Up

Norway

Patent: 19025
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 73752
Estimated Expiration: ⤷ Sign Up

Patent: 40731
Estimated Expiration: ⤷ Sign Up

Patent: 70090
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 73752
Estimated Expiration: ⤷ Sign Up

Patent: 70090
Estimated Expiration: ⤷ Sign Up

San Marino

Patent: 201000002
Estimated Expiration: ⤷ Sign Up

Patent: 01000002
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 245
Estimated Expiration: ⤷ Sign Up

Patent: 878
Estimated Expiration: ⤷ Sign Up

Patent: 449
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 2198
Estimated Expiration: ⤷ Sign Up

Patent: 201509887U
Estimated Expiration: ⤷ Sign Up

Patent: 201912675V
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 73752
Estimated Expiration: ⤷ Sign Up

Patent: 40731
Estimated Expiration: ⤷ Sign Up

Patent: 70090
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 0908826
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1549876
Estimated Expiration: ⤷ Sign Up

Patent: 100049010
Estimated Expiration: ⤷ Sign Up

Patent: 150036210
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 67665
Estimated Expiration: ⤷ Sign Up

Patent: 75797
Estimated Expiration: ⤷ Sign Up

Patent: 14092
Estimated Expiration: ⤷ Sign Up

Patent: 03444
Estimated Expiration: ⤷ Sign Up

Tunisia

Patent: 09000514
Estimated Expiration: ⤷ Sign Up

Turkey

Patent: 1903488
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 467
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Spain	2867505		⤷ Sign Up
South Africa	200908826	SALTS OF THE JANUS KINASE INHIBITOR (R)-3-(4-(7H-PYRROLO[2,3-D]PYRIMIDIN-4-YL)-1H-PYRAZOL-1-YL)-3-CYCLOPENTHYLPROPANEITRILE	⤷ Sign Up
Lithuania	PA2017012		⤷ Sign Up
Hungary	E030235		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for JAKAFI

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	2013C/014	Belgium	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001 20120828
2455382	LUC00016	Luxembourg	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001-016 20150313
1966202	2013/004	Ireland	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202	92137	Luxembourg	⤷ Sign Up	PRODUCT NAME: RUXOLITINIB,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

Summary for JAKAFI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JAKAFI

Recent Clinical Trials for JAKAFI

Pharmacology for JAKAFI

Anatomical Therapeutic Chemical (ATC) Classes for JAKAFI

Paragraph IV (Patent) Challenges for JAKAFI

Patents protecting JAKAFI

FDA Regulatory Exclusivity protecting JAKAFI

When does loss-of-exclusivity occur for JAKAFI?

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JAKAFI