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Sunitinib malate - Generic Drug Details

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What are the generic sources for sunitinib malate and what is the scope of patent protection?

Sunitinib malate is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sunitinib malate has eighty patent family members in forty-two countries.

There are eight drug master file entries for sunitinib malate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for sunitinib malate

International Patents:	80
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Suppliers / Packagers:	1
Bulk Api Vendors:	151
Clinical Trials:	159
Patent Applications:	7,290
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sunitinib malate
DailyMed Link:	sunitinib malate at DailyMed

Recent Clinical Trials for sunitinib malate

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

Sponsor	Phase
Graybug Vision	Phase 2
VU University Medical Center	Phase 2/Phase 3
University of Colorado, Denver	Phase 1

See all sunitinib malate clinical trials

Generic filers with tentative approvals for SUNITINIB MALATE

Applicant	Application No.	Strength	Dosage Form
		EQ 50MG BASE	CAPSULE;ORAL
		EQ 37.5MG BASE	CAPSULE;ORAL
		EQ 25MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sunitinib malate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SUNITINIB MALATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
SUTENT	CAPSULE;ORAL	sunitinib malate	021938	2010-01-26

US Patents and Regulatory Information for sunitinib malate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-002	Jan 26, 2006		RX	Yes	No					Y
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-003	Jan 26, 2006		RX	Yes	Yes					Y
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-002	Jan 26, 2006		RX	Yes	No					Y
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-001	Jan 26, 2006		RX	Yes	No					Y
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-001	Jan 26, 2006		RX	Yes	No					Y

International Patents for sunitinib malate

Country	Patent Number	Estimated Expiration
Hong Kong	1050642
Lithuania	C1255752
Iceland	2491
Luxembourg	91407
Brazil	0108394

Supplementary Protection Certificates for sunitinib malate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	PA2008002,C1255752	Lithuania		PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752	C01255752/02	Switzerland		PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010
1255752	SPC/GB08/007	United Kingdom		PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L-MALATE SALT.; REGISTERED: UK EU/1/06/347/001 20060724; UK EU/1/06/347/002 20060724; UK EU/1/06/347/003 20060724
1255752	91407	Luxembourg		PRODUCT NAME: SUNITINIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL L-MALATE (SUTENT ); AUTHORISATION NUMBER AND DATE: EU/1/06/347/001-003 - SUTENT-SUNITINIB 20060724
1255752	300332	Netherlands		PRODUCT NAME: SUNITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET L-MALAATZOUT; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060724