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Cabozantinib s-malate - Generic Drug Details

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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-three patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for Generic Name: cabozantinib s-malate

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Clinical Trials: see list105
Drug Prices:see low prices
DailyMed Link:cabozantinib s-malate at DailyMed

Pharmacology for Ingredient: cabozantinib s-malate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exelixis Inc
CABOMETYX
cabozantinib s-malate
TABLET;ORAL208692-002Apr 25, 2016RXYesNo8,877,776► subscribeYY ► subscribe
Exelixis Inc
CABOMETYX
cabozantinib s-malate
TABLET;ORAL208692-001Apr 25, 2016RXYesNo8,877,776► subscribeYY ► subscribe
Exelixis
COMETRIQ
cabozantinib s-malate
CAPSULE;ORAL203756-002Nov 29, 2012RXYesYes7,579,473► subscribeYY ► 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
8,476,298c-Met modulators and method of use► subscribe
2,014,155,378► subscribe
9,174,947c-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
Slovenia2392564► subscribe
Denmark2392564► subscribe
Japan5325172► 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
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 20140326
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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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