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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 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 eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ruxolitinib phosphate has two hundred and twenty-seven patent family members in forty-five countries.

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

Summary for ruxolitinib phosphate

International Patents:	227
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	14
Patent Applications:	77
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ruxolitinib phosphate
DailyMed Link:	ruxolitinib phosphate at DailyMed

Recent Clinical Trials for ruxolitinib phosphate

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

Sponsor	Phase
Zhengzhou University	Phase 4
Philipps University Marburg Medical Center	Phase 2
Memorial Sloan Kettering Cancer Center	Phase 2

See all ruxolitinib phosphate clinical trials

Pharmacology for ruxolitinib phosphate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for RUXOLITINIB PHOSPHATE

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

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	202192-002	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-002	Nov 16, 2011		RX	Yes	No			Y	Y
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	Nov 16, 2011		RX	Yes	No
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192-001	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

International Patents for ruxolitinib phosphate

Country	Patent Number	Estimated Expiration
European Patent Office	3838903
Spain	2575797
Poland	2426129
Denmark	2740731
Hong Kong	1168090
Argentina	057995
Croatia	P20150837

Supplementary Protection Certificates for ruxolitinib phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1966202	SPC/GB13/005	United Kingdom		PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/12/773/001 20120828; UK EU/1/12/773/002 20120828; UK EU/1/12/773/003 20120828
1966202	C 2013 005	Romania		PRODUCT NAME: RUXOLITINIB SAU O SARE FARMACEUTIC ACCEPTABILA AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/773/001, RO EU/1/12/773/002, RO EU/1/12/773/003; DATE OF NATIONAL AUTHORISATION: 20120823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/773/001, EMEA EU/1/12/773/002, EMEA EU/1/12/773/003; DATE OF FIRST AUTHORISATION IN EEA: 20120823
1966202	PA2013002,C1966202	Lithuania		PRODUCT NAME: RUXOLITINIBUM; REGISTRATION NO/DATE: EU/1/12/773/001-EU/1/12/773/003, 0120823
1966202	CA 2013 00005	Denmark
1966202	2013C/014	Belgium		PRODUCT NAME: RUXOLITINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/773/001 20120828
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
1966202	2013/004	Ireland		PRODUCT NAME: RUXOLITINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THREOF; REGISTRATION NO/DATE: EU/1/12/773/001-003 20120823