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
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
Eurasian Patent Organization	005996	ПИРРОЛЗАМЕЩЕННЫЙ 2-ИНДОЛИНОН, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ), СПОСОБ МОДУЛИРОВАНИЯ КАТАЛИТИЧЕСКОЙ АКТИВНОСТИ ПРОТЕИНКИНАЗЫ, СПОСОБ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ НАРУШЕНИЯ В ОРГАНИЗМЕ, СВЯЗАННОГО С ПРОТЕИНКИНАЗОЙ (PYRROLE SUBSTITUTED 2-INDOLINONE, PHARMACEUTICAL COMPOSITION, METHOD OF MODULATING CATALYTIC ACTIVITY OF PROTEIN KINASE, METHOD OF PREVENTION AND TREATMENT OF DISORDERS RELATED TO PROTEIN KINASE)
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)
Montenegro	00415	PIROL SUPSTITUISANI 2-INDOL PROTEIN KINAZNI INHIBITORI (PYRROLE SUBSTITUTED 2-INDOLINONE PROTEIN KINASE INHIBITORS)
China	1329390
Australia	2001239770
Austria	331514

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	C 2008 002	Romania		PRODUCT NAME: N-[2-(DIETILAMINO)ETIL]-5-[(Z)-(5-FLUORO-2-OXO-1,2-DIHIDRO-3H-INDOL-3-ILIDEN)METIL]-2,4-DIMETIL-1H-PIROL-3-CAROXAMIDA - SUNITINIB, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE FARMACEUTIC,INCLUSIV A SARII L-MALAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/06/347/001, RO EU/1/06/347/002, RO EU/1/06/347/003; DATE OF NATIONAL AUTHORISATION: 20060719; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003; DATE OF FIRST AUTHORISATION IN EEA: 20060719
1255752	SPC003/2010	Ireland		SPC003/2010: 20100702, EXPIRES: 20240922
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
1255752	132010901817031	Italy		PRODUCT NAME: TOCERANIB FOSFATO(PALLADIA); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/09/100/001-002-003, 20090923
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	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