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Last Updated: February 22, 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 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
National Cancer Institute (NCI)Phase 2/Phase 3
Children's Oncology GroupPhase 2/Phase 3
Oregon Health and Science UniversityPhase 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 ⤷  Try a Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 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

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2213661 C20140029 00117 Estonia ⤷  Try a Trial PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661 C300678 Netherlands ⤷  Try a Trial PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661 583 Finland ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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