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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. Two suppliers are listed 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:	2
Bulk Api Vendors:	154
Clinical Trials:	159
Patent Applications:	4,673
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in sunitinib malate?	sunitinib malate excipients list
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

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
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009		RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009		RX	Yes	No					Y
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009		RX	Yes	No
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	021938-003	Jan 26, 2006		RX	Yes	Yes					Y

International Patents for sunitinib malate

Country	Patent Number	Estimated Expiration
Denmark	1255752
Brazil	PI0117360
Netherlands	300430
Japan	2003523340
Luxembourg	91657
Austria	331514
World Intellectual Property Organization (WIPO)	0145689

Supplementary Protection Certificates for sunitinib malate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	C200800007	Spain		PRODUCT NAME: SUNITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/06/347/001-003; DATE OF AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UEEU/1/06/347/001-003; DATE OF FIRST AUTHORISATION IN EEA: 20060719
1255752	CA 2010 00004	Denmark		PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT
1255752	5/2008	Austria		PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719
1255752	2008/004	Ireland		PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE L-MALATE SALT; AUTHORISATION NO/DATE: IRELAND EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752	PA2010002,C1255752	Lithuania		PRODUCT NAME: TOCERANIBUM; REGISTRATION NO/DATE: EU/2/09/100/001, 2009 09 23 EU/2/09/100/002, 2009 09 23 EU/2/09/100/003 20090923
1255752	SPC003/2010	Ireland		SPC003/2010: 20100702, EXPIRES: 20240922
1255752	312	Finland