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Last Updated: June 21, 2024

SUTENT Drug Patent Profile


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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 16th, 2021.

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Drug patent expirations by year for SUTENT
Drug Prices for SUTENT

See drug prices for SUTENT

Recent Clinical Trials for SUTENT

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

SponsorPhase
University of MiamiPhase 2
National Anti Doping Laboratory, BelarusPhase 1
JLLC NatiVitaPhase 1

See all SUTENT clinical trials

Pharmacology for SUTENT
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for SUTENT

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

Country Patent Number Title Estimated Expiration
Germany 60129794 ⤷  Sign Up
Hong Kong 1050642 ⤷  Sign Up
Brazil PI0117360 inibidores de proteína de quinase de 2-indolinona de pirrol substituído, seus sais e composições farmacêuticas compreendendo os mesmos ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SUTENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 2010C/009 Belgium ⤷  Sign Up PRODUCT NAME: TOCERANIB; AUTHORISATION NUMBER AND DATE: EU/2/09/100/001 20090923
1255752 CA 2010 00004 Denmark ⤷  Sign Up PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT
1255752 SPC/GB10/008 United Kingdom ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.