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Last Updated: March 19, 2024

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

Cabozantinib s-malate has two hundred and thirty-one patent family members in thirty-two countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cabozantinib s-malate
Generic Entry Dates for cabozantinib s-malate*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for cabozantinib s-malate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for cabozantinib s-malate

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

SponsorPhase
Children's Oncology GroupPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3
OHSU Knight Cancer InstitutePhase 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 Strength NDA ANDAs Submitted Submissiondate
CABOMETYX Tablets cabozantinib s-malate 20 mg, 40 mg and 60 mg 208692 1 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for cabozantinib s-malate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2012109510 ⤷  Try a Trial
European Patent Office 2609919 Procédé de préparation de modulateurs c-Met (Process for preparing c-Met modulators) ⤷  Try a Trial
Denmark 2392565 ⤷  Try a Trial
Brazil PI1006812 sal de malato de n-(4-{[6,7-bis(metiloxi)quinolin-4-il]fenil)-n-(4-fluorofenil)ciclopropane-1,1-dicarboxamida ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 PA2014033,C2213661 Lithuania ⤷  Try a 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 CR 2014 00039 Denmark ⤷  Try a Trial PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
2213661 220 50007-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2213661 300678 Netherlands ⤷  Try a 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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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 verification 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.