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Ruxolitinib phosphate - Generic Drug Details

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What are the generic drug 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.

Ruxolitinib phosphate has one hundred and eighty-one patent family members in forty-one countries.

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

Summary for ruxolitinib phosphate

International Patents:	181
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	43
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	202192-004	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	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	202192-002	Nov 16, 2011		RX	Yes	No

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Non-Orange Book US Patents for ruxolitinib phosphate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,530,485	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
8,541,425	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors
8,933,086	Heteroaryl substituted pyrrolo[2,3-B]pyridines and pyrrolo[2,3-B]pyrimidines as Janus kinase inhibitors
8,946,245	Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors

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International Patents for ruxolitinib phosphate

Country	Document Number	Estimated Expiration
Portugal	2455382
European Patent Office	2348023
Morocco	31517
Luxembourg	92137

Supplementary Protection Certificates for ruxolitinib phosphate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0870	Netherlands		PRODUCT NAME: RUXOLITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/12/773/001-016 20150313
2017000020	Germany		PRODUCT NAME: RUXOLITINIB, ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/773/001-003 20150311
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
C0007	France		PRODUCT NAME: RUXOLITINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120828