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Last Updated: July 6, 2020

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

Cabozantinib s-malate has one hundred and ninety-one patent family members in twenty-nine countries.

There are three drug master file entries for cabozantinib s-malate. One supplier is listed for this compound.

Recent Clinical Trials for cabozantinib s-malate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 1/Phase 2
ExelixisPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2

See all cabozantinib s-malate clinical trials

Pharmacology for cabozantinib s-malate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for CABOZANTINIB S-MALATE
Tradename Dosage Ingredient NDA Submissiondate
CABOMETYX TABLET;ORAL cabozantinib s-malate 208692 2019-08-16

US Patents and Regulatory Information for cabozantinib s-malate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No   Start Trial   Start Trial   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 C 2014 036 Romania   Start Trial PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF FIRST AUTHORISATION IN EEA: 20140321
2213661 C20140029 00117 Estonia   Start Trial PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661 92508 Luxembourg   Start Trial PRODUCT 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
2213661 583 Finland   Start Trial
2213661 PA2014033,C2213661 Lithuania   Start Trial PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661 300678 Netherlands   Start Trial PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Boehringer Ingelheim
Mallinckrodt
Baxter
McKinsey

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