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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Army
Medtronic
Citi
Farmers Insurance
Argus Health
Teva
Boehringer Ingelheim
Baxter
Cerilliant

Generated: November 21, 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 seventy-three patent family members in thirty-nine countries and twenty-one supplementary protection certificates in ten 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.
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
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-002Jan 26, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-002Jan 26, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV (Patent) Challenges 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
Malaysia130363► Subscribe
Germany60129794► Subscribe
Australia3436301► Subscribe
Israel151127► Subscribe
Slovakia287142► Subscribe
World Intellectual Property Organization (WIPO)0145689► Subscribe
World Intellectual Property Organization (WIPO)0160814► Subscribe
Bulgaria107078► Subscribe
Hong Kong1050642► Subscribe
Eurasian Patent Organization005996► 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
2008000002Germany► SubscribePRODUCT NAME: SUNITINIB, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, EINSCHLIESSLICH DES L-MALATSALZES; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060719
C/GB08/007United Kingdom► SubscribePRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L- MALATE SALT; REGISTRATION NO/DATE: EU/1/06/347/001 - 003 20060724
407Luxembourg► Subscribe91407, EXPIRES: 20210719
2008002,C1255752Lithuania► SubscribePRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
C/GB10/008United Kingdom► SubscribeSUPPLEMENTARY 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
C004/2008Ireland► SubscribeSPC004/2008: 20081105, EXPIRES: 20210718
C003/2010Ireland► SubscribeSPC003/2010: 20100702, EXPIRES: 20240922
2010 00004Denmark► Subscribe
2Finland► Subscribe
2010000004Germany► SubscribePRODUCT NAME: TOCERANIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/2/09/100/001-003 20090923
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Chubb
Mallinckrodt
Queensland Health
Federal Trade Commission
Argus Health
Covington
Cipla
Novartis
Moodys

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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