JAKAFI Drug Patent Profile

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

Summary for JAKAFI

International Patents:	233
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	75
Patent Applications:	583
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

See drug prices for JAKAFI

DrugPatentWatch^® Estimated Generic Entry Opportunity 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:

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

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 twenty-one US patents and four FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting JAKAFI

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
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No			Y	Y

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

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Guatemala

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Nicaragua

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

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 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
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
Slovenia	2426129

Supplementary Protection Certificates for JAKAFI

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