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Serving leading biopharmaceutical companies globally:

Mallinckrodt
UBS
Dow
Julphar
Teva
Medtronic
McKesson
Covington
Baxter
Accenture

Generated: November 23, 2017

DrugPatentWatch Database Preview

Sunitinib malate - Generic Drug Details

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What are the generic sources for sunitinib malate and what is the scope of sunitinib malate freedom to operate?

Sunitinib malate
is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sunitinib malate has seventy-three patent family members in thirty-nine countries and twenty-one supplementary protection certificates in ten countries.

There are six drug master file entries for sunitinib malate. One supplier is listed for this compound. There is one tentative approval for this compound.

Pharmacology for sunitinib malate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Tentative approvals for SUNITINIB MALATE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 12.5MG BASECAPSULE;ORAL
u► SubscribeEQ 50MG BASECAPSULE;ORAL
u► SubscribeEQ 37.5MG BASECAPSULE;ORAL
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;ORAL021938-003Jan 26, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-002Jan 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;ORAL021938-001Jan 26, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes► Subscribe► SubscribeYY ► Subscribe
Cppi Cv
SUTENT
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
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
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Non-Orange Book Patents for Generic Ingredient: sunitinib malate

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 Ingredient: sunitinib malate

Country Document Number Estimated Expiration
Austria331514► Subscribe
Norway2008019► Subscribe
European Patent Office1255752► Subscribe
Czech Republic303705► Subscribe
Iceland6501► Subscribe
Iceland2491► Subscribe
MexicoPA02006263► Subscribe
Japan2003523340► Subscribe
Slovakia13262002► Subscribe
Netherlands300332► 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: SUNITINIB MALATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010002Lithuania► SubscribePRODUCT 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
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
1255752/02Switzerland► SubscribePRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010
2008 00015Denmark► Subscribe
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
C003/2010Ireland► SubscribeSPC003/2010: 20100702, EXPIRES: 20240922
1255752/01Switzerland► SubscribePRODUCT NAME: SUNITINIB; REGISTRATION NUMBER/DATE: SWISSMEDIC 57563 28.04.2006
2Finland► Subscribe
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
2008002Lithuania► SubscribePRODUCT NAME: SUNITINIBUM; REG. NO/DATE: EU/1/06/347/001-003 20070808
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Colorcon
QuintilesIMS
Harvard Business School
McKinsey
Dow
Citi
Johnson and Johnson
Argus Health

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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