Sutent Drug Patent Profile

Which patents cover Sutent, and when can generic versions of Sutent launch?

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. Nine 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
National Anti Doping Laboratory, Belarus	Phase 1
JLLC NatiVita	Phase 1

See all Sutent clinical trials

Pharmacology for Sutent

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for Sutent

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Hungary	228979	PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS
Canada	2395461	PROCEDES DE MODULATION DE LA FONCTION KINASE DE PROTEINE TYROSINE DE TYPE C-KIT AVEC DES COMPOSES INDOLINONE (METHODS OF MODULATING C-KIT TYROSINE KINASE FUNCTION WITH INDOLINONE COMPOUNDS)
Iceland	6501
Spain	2290117
Norway	2019005
Serbia	50444	INHIBITORI 2-INDOLINON PROTEIN KINAZE SUPSTITUISANI PIROLOM (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS)

Supplementary Protection Certificates for Sutent

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	C 2010 003	Romania		PRODUCT NAME: (Z)-5-[(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL}-2,4-DIMETIL-N-(2-PIROLIDIN-1-ILETIL)-1H-PIROL-3-CARBOXAMIDA - TOCERANIB, INCLUSIV SUB FORMA DE FOSFAT; NATIONAL AUTHORISATION NUMBER: RO EU/2/09/100/001, RO EU/2/09/100/002, RO EU/2/09/100/003; DATE OF NATIONAL AUTHORISATION: 20090923; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/2/09/100/001, EMEA EU/2/09/100/002, EMEA EU/2/09/100/003; DATE OF FIRST AUTHORISATION IN EEA: 20090923
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	SPC003/2010	Ireland		SPC003/2010: 20100702, EXPIRES: 20240922
1255752	132010901817031	Italy		PRODUCT NAME: TOCERANIB FOSFATO(PALLADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/09/100/001-002-003, 20090923
1255752	SPC004/2008	Ireland		SPC004/2008: 20081105, EXPIRES: 20210718
1255752	SPC/GB10/008	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/008 GRANTED TO SUGEN INC. AND PHARMACIA AND UPJOHN COMPANY LLC IN RESPECT OF THE PRODUCT TOCERANIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE PHOSPHATE SALT.?, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6380 DATED 31 AUGUST 2011 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 24 SEPTEMBER 2024