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Last Updated: October 5, 2022

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

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

One supplier is listed for this compound.

Recent Clinical Trials for cabozantinib s-malate

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

SponsorPhase
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
University of UtahPhase 2

See all cabozantinib s-malate clinical trials

Pharmacology for cabozantinib s-malate
Drug ClassKinase Inhibitor
Mechanism of Action Protein 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 COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Australia 2012214322 Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds See Plans and Pricing
Canada 2537812 MODULATEURS DE C-MET ET PROCEDE D'UTILISATION (C-MET MODULATORS AND METHODS OF USE) See Plans and Pricing
Singapore 187060 C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
>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 Lithuania See Plans and Pricing PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661 CA 2014 00039 Denmark See Plans and Pricing PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661 CR 2014 00039 Denmark See Plans and Pricing PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Baxter
McKinsey

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