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. 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
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

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

International Patents for SUTENT

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

Country	Patent Number	Title	Estimated Expiration
Norway	325532
Ukraine	73976	ЗАМЕЩЕННЫЕ ПИРРОЛОМ 2-ИНДОЛИНОНЫ, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СПОСОБ МОДУЛЯЦИИ КАТАЛИТИЧЕСКОЙ АКТИВНОСТИ ПРОТЕИНКИНАЗЫ И СПОСОБ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ ЗАБОЛЕВАНИЯ, СВЯЗАННОГО С ПРОТЕИНКИНАЗОЙ;ЗАМІЩЕНІ ПІРОЛОМ 2-ІНДОЛІНОНИ, ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, СПОСІБ МОДУЛЯЦІЇ КАТАЛІТИЧНОЇ АКТИВНОСТІ ПРОТЕЇНКІНАЗИ ТА СПОСІБ ЛІКУВАННЯ АБО ПРОФІЛАКТИКИ ЗАХВОРЮВАННЯ, ПОВ'ЯЗАНОГО З ПРОТЕЇНКІНАЗОЮ (PYRROLE SUBSTITUTED 2-INDOLINONE COMPOUNDS, A PHARMACEUTICAL COMPOSITION, A METHOD FOR MODULATION OF CATALYTIC ACTIVITY OF PROTEIN KINASE AND A METHOD FOR THE TREATMENT OF DISEASE RELATED TO PROTEIN KINASE)
Mexico	PA02008021	INDOLINONAS SUSTITUIDAS CON PIRROLES INHIBIDORAS DE PROTEINQUINASAS. (PYRROLE SUBSTITUTED 2 INDOLINONE PROTEIN KINASE INHIBITORS.)

Supplementary Protection Certificates for SUTENT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1255752	91657	Luxembourg		91657, EXPIRES: 20240923
1255752	312	Finland
1255752	08C0002	France		PRODUCT NAME: SUNITINIB MALATE; REGISTRATION NO/DATE: EU/1/06/347/001 20060724