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Serving 500+ biopharmaceutical companies globally:

Julphar
Cantor Fitzgerald
Accenture
AstraZeneca
US Army
Medtronic
Merck
Fish and Richardson
Johnson and Johnson
Chinese Patent Office

Generated: July 24, 2017

DrugPatentWatch Database Preview

SUTENT Drug Profile

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What is the patent landscape for Sutent, and what generic Sutent 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 sixty-eight patent family members in thirty-nine countries.

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

Summary for Tradename: SUTENT

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list110
Clinical Trials: see list142
Patent Applications: see list5,474
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SUTENT at DailyMed

Pharmacology for Tradename: SUTENT

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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;ORAL021938-001Jan 26, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-002Jan 26, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV activity for: SUTENT

Drugname Dosage Strength RLD Submissiondate
sunitinib malateCapsules12.5 mg, 25 mg, 37.5 mg and 50 mgSutent1/26/2010

Non-Orange Book Patents for Tradename: SUTENT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,572,924Pyrrole substituted 2-indolinone protein kinase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: SUTENT

Country Document Number Estimated Expiration
Slovenia1255752► Subscribe
Luxembourg91407► Subscribe
Austria369359► Subscribe
MexicoPA02006263► Subscribe
Germany122010000004► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SUTENT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00015Denmark► Subscribe
1255752/01Switzerland► SubscribePRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006
C0002France► SubscribePRODUCT NAME: SUNITINIB ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUES ACCEPTABLES ET NOTAMMENT LE MALATE DE SUNITINIB; REGISTRATION NO/DATE IN FRANCE: EU/1/06/347/001 DU 20060719; REGISTRATION NO/DATE AT EEC: EU/1/06/347/001 DU 20060719
C0003France► SubscribePRODUCT NAME: TOCERAMIB ET OPTIONELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, ET EN PARTICULIER LE PHOSPHATE DE TOCERANIB; REGISTRATION NO/DATE IN FRANCE: EU/2/09/100/001 DU 20090923; REGISTRATION NO/DATE AT EEC: EU/2/09/100/001 DU 20090923
407Luxembourg► Subscribe91407, EXPIRES: 20210719
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chubb
US Department of Justice
McKesson
Citi
QuintilesIMS
Queensland Health
Cerilliant
Covington
Express Scripts
Cipla

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 verifification 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.

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