JAKAFI XR Drug Patent Profile

Which patents cover Jakafi Xr, and when can generic versions of Jakafi Xr launch?

Jakafi Xr is a drug marketed by Incyte Corp and is included in one NDA. There are seventeen patents protecting this drug.

This drug has three hundred and eight patent family members in fifty countries.

The generic ingredient in JAKAFI XR 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 Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 14, 2033. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for JAKAFI XR

International Patents:	308
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	81
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JAKAFI XR
DailyMed Link:	JAKAFI XR at DailyMed

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

Constraining patent/regulatory exclusivity:

10,874,616

NDA:

217180

Dosage:

TABLET, EXTENDED RELEASE;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 XR

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

Sponsor	Phase
Incyte Corporation	PHASE2
University of Pennsylvania	PHASE2
National Heart, Lung, and Blood Institute (NHLBI)	PHASE2

See all JAKAFI XR clinical trials

Pharmacology for JAKAFI XR

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

US Patents and Regulatory Information for JAKAFI XR

JAKAFI XR is protected by forty-one US patents.

This potential generic entry date is based on patent 10,874,616.

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 XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-002	May 1, 2026		RX	Yes	No	11,576,865		Y
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-001	May 1, 2026		RX	Yes	No	8,530,485		Y
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-004	May 1, 2026		RX	Yes	No	7,598,257		Y	Y
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-003	May 1, 2026		RX	Yes	No	11,744,832
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-004	May 1, 2026		RX	Yes	No	8,415,362		Y	Y
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-003	May 1, 2026		RX	Yes	No	7,598,257		Y	Y
Incyte Corp	JAKAFI XR	ruxolitinib phosphate	TABLET, EXTENDED RELEASE;ORAL	217180-002	May 1, 2026		RX	Yes	No	9,079,912

International Patents for JAKAFI XR

When does loss-of-exclusivity occur for JAKAFI XR?

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

Argentina

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 XR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2008266183
Brazil	PI0814254
Canada	2689663
China	101932582
China	103524509
Colombia	6251256
Costa Rica	11151

Supplementary Protection Certificates for JAKAFI XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	C300574	Netherlands		PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
1966202	PA2013002	Lithuania
1966202	CA 2013 00005	Denmark
1966202	C20130003 00072	Estonia		PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
1966202	1390005-5	Sweden		PRODUCT NAME: RUXOLITINIB, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/12/773/001, 2012-08-23; 1290041-1, 2190036-0, 1390005-5, 1490063-3, 2090018-9, 1490027-8, 1990004-2, 2290011-2, 1390026-1 2090037-9, 2390008-7, 2290049-2: SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG (BESLUT I PMAE 7804-24).
1966202	92137	Luxembourg		PRODUCT NAME: RUXOLITINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001-003 20120828
1966202	PA2013002,C1966202	Lithuania		PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 2 00120823