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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Express Scripts
McKesson
Johnson and Johnson
Colorcon
US Army
Argus Health
Dow
Citi

Generated: December 18, 2017

DrugPatentWatch Database Preview

Cabozantinib s-malate - Generic Drug Details

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

Cabozantinib s-malate
is the generic ingredient in two branded drugs marketed by Exelixis and Exelixis Inc, and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabozantinib s-malate has one hundred and forty-seven patent family members in twenty-eight countries and twelve supplementary protection certificates in nine countries.

There is one drug master file entry for cabozantinib s-malate. One supplier is listed for this compound.

Summary for cabozantinib s-malate

Pharmacology for cabozantinib s-malate

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
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-002Apr 25, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-002Apr 25, 2016RXYesNo► Subscribe► Subscribe► Subscribe
ExelixisCOMETRIQcabozantinib s-malateCAPSULE;ORAL203756-002Nov 29, 2012RXYesYes► Subscribe► Subscribe► Subscribe
ExelixisCOMETRIQcabozantinib s-malateCAPSULE;ORAL203756-001Nov 29, 2012RXYesNo► Subscribe► SubscribeYY► Subscribe
ExelixisCOMETRIQcabozantinib s-malateCAPSULE;ORAL203756-001Nov 29, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-001Apr 25, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-001Apr 25, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-003Apr 25, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-001Apr 25, 2016RXYesNo► Subscribe► SubscribeYY► Subscribe
Exelixis IncCABOMETYXcabozantinib s-malateTABLET;ORAL208692-001Apr 25, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: cabozantinib s-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
9,174,947c-Met modulators and methods of use► Subscribe
2,014,155,378► Subscribe
9,809,549Malate salt of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'(4-fluorophenyl)cycl- opropane-1,1-dicarboxamide, and crystalline forms therof for the treatment of cancer► Subscribe
8,476,298c-Met modulators and method of use► Subscribe
8,178,532c-Met modulators and method of use► Subscribe
8,067,436c-Met modulators and methods of use► 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: cabozantinib s-malate

Country Document Number Estimated Expiration
Spain2436888► Subscribe
European Patent Office2609919► Subscribe
World Intellectual Property Organization (WIPO)2010083414► Subscribe
Denmark2210607► Subscribe
Denmark2392564► Subscribe
Japan2015131859► Subscribe
South Korea20140044782► Subscribe
Portugal2210607► Subscribe
Hong Kong1164313► Subscribe
Singapore10201609324U► 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: CABOZANTINIB S-MALATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014033,C2213661Lithuania► SubscribePRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2014033Lithuania► SubscribePRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
0140029 00117Estonia► SubscribePRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
0678Netherlands► SubscribePRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2014000091Germany► SubscribePRODUCT NAME: CABOZANTINIB UND JEDES THERAPEUTISCHE AEQUIVALENT HIERVON WIE DURCH DAS GRUNDPATENT GESCHUETZT, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140321
2014 00039Denmark► SubscribePRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
C0067France► SubscribePRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326
2014 00039Denmark► SubscribePRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
508Luxembourg► SubscribePRODUCT NAME: CABOZANTINIB ET TOUTES LES FORMES THERAPEUTIQUEMENT EQUIVALENTES QUI EN DERIVENT TELLES QUE PROTEGEES PAR LE BREVET DE BASE, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140326
90053-4Sweden► SubscribePRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326
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Serving leading biopharmaceutical companies globally:

Julphar
Argus Health
Express Scripts
Dow
Johnson and Johnson
McKesson
Citi
Federal Trade Commission
Moodys
Cantor Fitzgerald

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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