DrugPatentWatch Database Preview

JAKAFI Drug Profile

Email this page to a colleague

« Back to Dashboard

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 fourteen patent family members in forty-four 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.

US ANDA Litigation and 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 June 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

Summary for JAKAFI

International Patents:	214
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	44
Patent Applications:	34
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

See drug prices for JAKAFI

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.

Recent Clinical Trials for JAKAFI

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

Sponsor	Phase
University of Washington	Phase 2
Myeloproliferative Neoplasms Research Consortium	Phase 2
Actuate Therapeutics Inc.	Phase 2

See all JAKAFI clinical trials

Recent Litigation for JAKAFI

Identify potential future generic entrants

PTAB Litigation

Petitioner	Date
	2017-06-27

See all JAKAFI litigation

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; phosphoric acid

(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

AS-74723

AX8243856

BCP9000783

BIFK0028

CHEBI:66917

CHEMBL1795071

CS-0326

D09960

DTXSID00911086

EX-A2660

FT-0674486

HY-50858

INC 424 phosphate

INC-424

INCB 018424 phosphate

INCB-018424 phosphate

INCB-018424 Salt

INCB-18424

INCB-18424 PHOSPHATE

INCB-424

INCB018424 PHOSPHATE

INCB018424 SALT

J-501793

Jakafi (TN)

Jakavi

Jakavi (TN)

JFMWPOCYMYGEDM-XFULWGLBSA-N

KS-000006SN

OR302722

Phosphoric acid--3-cyclopentyl-3-[4-(1H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]propanenitrile (1/1)

Q27135517

Ruxolitinib (INCB-18424) phosphate

Ruxolitinib (phosphate)

Ruxolitinib phosphate

Ruxolitinib phosphate (JAN/USAN)

Ruxolitinib phosphate [USAN]

Ruxolitinib phosphate salt

Ruxolitinib phosphate(INCB018424)

Ruxolitinib, Phosphate Salt

s5243

SB20028

SC-73865

SCHEMBL1369365

UNII-436LRU32H5

W-5760

Paragraph IV (Patent) Challenges for JAKAFI

Tradename	Dosage	Ingredient	NDA	Submissiondate
JAKAFI	TABLET;ORAL	ruxolitinib phosphate	202192	2015-12-17

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

International Patents for JAKAFI

Country	Patent Number	Estimated Expiration
Cyprus	1118607
Colombia	6251256
Serbia	54683
Lithuania	3070090

Supplementary Protection Certificates for JAKAFI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	145 1-2013	Slovakia		FORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
2455382	CR 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
2455382	300870	Netherlands		PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
1966202	CR 2013 00005	Denmark		PRODUCT NAME: RUXOLITINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER RUXOLITINIB PHOSFAT; REG. NO/DATE: EU/1/12/773/001-003 20120823