➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Colorcon
Johnson and Johnson
Dow
Moodys

Last Updated: March 7, 2021

DrugPatentWatch Database Preview

SUTENT Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Sutent is a drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty patent family members in forty-two countries.

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

US ANDA Litigation and Generic Entry Outlook for Sutent

Sutent was eligible for patent challenges on January 26, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2021. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Summary for SUTENT
International Patents:80
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 89
Clinical Trials: 155
Patent Applications: 3,958
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
Drug patent expirations by year for SUTENT
Drug Prices for SUTENT

See drug prices for SUTENT

Generic Entry Opportunity Date for SUTENT
Generic Entry Date for SUTENT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SUTENT

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

SponsorPhase
Jiangsu HengRui Medicine Co., Ltd.Phase 3
Roche Pharma AGPhase 2
Ulrik LassenPhase 2

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 NDA Submissiondate
SUTENT CAPSULE;ORAL sunitinib malate 021938 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 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-004 Mar 31, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SUTENT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 C200800007 Spain   Start Trial 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 CA 2010 00004 Denmark   Start Trial PRODUCT NAME: TOCERANIB, HERUNDER TOCERANIBPHOSPHAT
1255752 5/2008 Austria   Start Trial PRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALAT-SALZES; REGISTRATION NO/DATE: EU/1/06/347/001- EU/1/06/347/003 20060719
1255752 2008/004 Ireland   Start Trial 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
1255752 PA2010002,C1255752 Lithuania   Start Trial 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 SPC003/2010 Ireland   Start Trial SPC003/2010: 20100702, EXPIRES: 20240922
1255752 312 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Boehringer Ingelheim
Colorcon
Medtronic
Mallinckrodt

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.