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Ruxolitinib phosphate - Generic Drug Details

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What are the generic sources for ruxolitinib phosphate and what is the scope of ruxolitinib phosphate freedom to operate?

Ruxolitinib phosphate is the generic ingredient in one branded drug marketed by Incyte Corp and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for ruxolitinib phosphate. One supplier is listed for this compound.

Summary for ruxolitinib phosphate

US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	41
Clinical Trials:	9
Patent Applications:	40
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ruxolitinib phosphate
DailyMed Link:	ruxolitinib phosphate at DailyMed

Pharmacology for ruxolitinib phosphate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for ruxolitinib phosphate

(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

Jakafi (TN)

Jakavi

Jakavi (TN)

JFMWPOCYMYGEDM-XFULWGLBSA-N

KS-000006SN

MFCD18452860

MolPort-028-912-691

RL00400

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 ruxolitinib phosphate

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	202192-001	Nov 16, 2011		RX	Yes	No				Y
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
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-005	Nov 16, 2011		RX	Yes	Yes			Y	Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No				Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-003	Nov 16, 2011		RX	Yes	No			Y	Y

International Patents for ruxolitinib phosphate

Country	Document Number	Estimated Expiration
Hungary	E030235
Tunisia	2009000514
Malaysia	154969
Mexico	342814
European Patent Office	2343298
Mexico	2009013402
South Korea	20110137406

Supplementary Protection Certificates for ruxolitinib phosphate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
5 1-2013	Slovakia		FORMER OWNER: INCYTE CORPORATION, WILMINGTON, DE, US;
13/004	Ireland		PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823
2017000020	Germany		PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
8	Finland
2013002	Lithuania
0130003 00072	Estonia		PRODUCT NAME: RUKSOLITINIIB;REG NO/DATE: K(2012)6018 LOPLIK 23.08.2012
2013	Austria		PRODUCT NAME: RUXOLITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823