SUTENT Drug Patent Profile

Which patents cover Sutent, and what generic alternatives are available?

Sutent is a drug marketed by Cppi Cv and is included in one NDA.

The generic ingredient in SUTENT is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sutent

A generic version of SUTENT was approved as sunitinib malate by SUN PHARM on August 16^th, 2021.

Summary for SUTENT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	220
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SUTENT
What excipients (inactive ingredients) are in SUTENT?	SUTENT excipients list
DailyMed Link:	SUTENT at DailyMed

See drug prices for SUTENT

Recent Clinical Trials for SUTENT

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

Sponsor	Phase
University of Miami	Phase 2
JLLC NatiVita	Phase 1
National Anti Doping Laboratory, Belarus	Phase 1

See all SUTENT clinical trials

Pharmacology for SUTENT

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for SUTENT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUTENT	Capsules	sunitinib malate	12.5 mg, 25 mg, 37.5 mg and 50 mg	021938	1	2010-01-26

US Patents and Regulatory Information for SUTENT

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	021938-001	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-003	Jan 26, 2006	AB	RX	Yes	Yes
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-002	Jan 26, 2006	AB	RX	Yes	No
Cppi Cv	SUTENT	sunitinib malate	CAPSULE;ORAL	021938-004	Mar 31, 2009	AB	RX	Yes	No

International Patents for SUTENT

See the table below for patents covering SUTENT around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	369359
Hungary	0204433
New Zealand	519697	Methods of modulating c-kit tyrosine protein kinase function with indolinone compounds
Portugal	1255536
European Patent Office	1255536	DERIVES D'INDOLINONE DESTINES A LA MODULATION DE LA TYROSINE PROTEINE KINASE DE TYPE c-KIT (INDOLINONE DERIVATIVES FOR MODULATION OF C-KIT TYROSINE PROTEIN KINASE)

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	PA2008002	Lithuania		PRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
1255752	PA2010002	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	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	SPC004/2008	Ireland		SPC004/2008: 20081105, EXPIRES: 20210718