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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 eighty patent family members in forty-one 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:	180
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	43
Clinical Trials:	34
Patent Applications:	27
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JAKAFI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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

(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

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

FT-0674486

HY-50858

INC-424

INCB 018424

INCB-018424 Salt

INCB-18424

INCB-424

INCB018424 SALT

J-501793

Jakafi (TN)

Jakavi

Jakavi (TN)

JFMWPOCYMYGEDM-XFULWGLBSA-N

KS-000006SN

MFCD18452860

MolPort-028-912-691

RL00400

Ruxolitinib (phosphate)

Ruxolitinib phosphate

Ruxolitinib phosphate (JAN/USAN)

Ruxolitinib phosphate [USAN]

Ruxolitinib phosphate salt

Ruxolitinib phosphate(INCB018424)

Ruxolitinib, Phosphate Salt

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	202192-004	Nov 16, 2011		RX	Yes	No			Y	Y
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	202192-005	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
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No

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	Document Number	Estimated Expiration
Poland	2474545
Singapore	179430
Cyprus	1118506
Japan	5017278
Portugal	2173752
Poland	1966202
Japan	2011252024

Supplementary Protection Certificates for JAKAFI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2013	Austria		PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
C0007	France		PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120828
00574	Netherlands		PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2013000015	Germany		PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
8	Finland
2017 00018	Denmark		PRODUCT NAME: RUXOLITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB FOSFAT; REG. NO/DATE: EU/1/12/773/001-016/C(2015)1740 20150313