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JAKAFI Drug 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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-six patent family members in forty-two 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.

Summary for JAKAFI

International Patents:	196
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	47
Clinical Trials:	35
Patent Applications:	30
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JAKAFI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JAKAFI
Prior Art and Litigation Support	Order Prior Art and Litigation support for JAKAFI
DailyMed Link:	JAKAFI at DailyMed

Generic Entry Opportunity Date for JAKAFI

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.

Pharmacology for JAKAFI

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for JAKAFI

(3R)-3-Cyclopentyl-3-(4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)propanenitrile phosphate (1:1)

(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile phosphate

(betaR)-beta-Cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazole-1-propanenitrile phosphate

(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate

(R)-3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate;Beta-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-(Betar)-1H-pyrazole-1-propanenitrile, phosphate

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate

1092939-17-7

1H-Pyrazole-1-propanenitrile, beta-cyclopentyl-4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betaR)-, phosphate (1:1)

436LRU32H5

AK161128

AKOS024464417

AX8243856

BCP9000783

BIFK0028

CHEBI:66917

CHEMBL1795071

CS-0326

D09960

EX-A2660

FT-0674486

HY-50858

INC-424

INCB 018424

INCB 018424 phosphate

INCB-018424 Salt

INCB-18424

INCB-424

INCB018424 SALT

J-501793

Jakafi (TN)

Jakavi

Jakavi (TN)

JFMWPOCYMYGEDM-XFULWGLBSA-N

KS-000006SN

MolPort-028-912-691

OR302722

RL00400

Ruxolitinib (phosphate)

Ruxolitinib phosphate

Ruxolitinib phosphate (JAN/USAN)

Ruxolitinib phosphate [USAN]

Ruxolitinib phosphate salt

Ruxolitinib phosphate(INCB018424)

Ruxolitinib, Phosphate Salt

SB20028

SC-73865

SCHEMBL1369365

UNII-436LRU32H5

W-5760

US Patents and Regulatory Information for 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	202192-005	Nov 16, 2011		RX	Yes	Yes			Y	Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes			Y	Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No			Y	Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-004	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No			Y	Y

Paragraph IV (Patent) Challenges for JAKAFI

Drugname	Dosage	Strength	RLD	Date
	Tablets	5 mg, 10 mg, 15 mg, 20 mg, and 25 mg

International Patents for JAKAFI

Country	Patent Number	Estimated Expiration
Australia	2008266183
European Patent Office	2455382
Serbia	55632
Lithuania	2455382
Taiwan	I468162
Hungary	S1700017

Supplementary Protection Certificates for JAKAFI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	C01966202/01	Switzerland		FORMER OWNER: INCYTE CORPORATION, US
1966202	PA2013002,C1966202	Lithuania		PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
1966202	448	Finland
1966202	2013C/014	Belgium		PRODUCT NAME: RUXOLITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001 20120828
1966202	PA2013002	Lithuania
2455382	CA 2017 00018	Denmark		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