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Last Updated: October 14, 2019

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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 seventy-seven 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.

Summary for cabozantinib s-malate
International Patents:177
US Patents:7
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 3
Suppliers / Packagers: 1
Bulk Api Vendors: 49
Clinical Trials: 19
Patent Applications: 1
DailyMed Link:cabozantinib s-malate at DailyMed
Recent Clinical Trials for cabozantinib s-malate

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SponsorPhase
ExelisisPhase 2
ExelixisPhase 2
United States Department of DefenseN/A

See all cabozantinib s-malate clinical trials

Pharmacology for cabozantinib s-malate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for cabozantinib s-malate
(2S)-2-Hydroxybutanedioic acid compd. with N-[4-[(
(2S)-2-Hydroxybutanedioic acid compd. with N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)
(2S)-2-Hydroxybutanedioic acid compd. with N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluor
(2S)-2-Hydroxybutanedioic acid compd. with N-[4-[(6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (1:1)
1,1-Cyclopropanedicarboxamide, N'-(4-((6,7-dimethoxy-4-quinolinyl)oxy]phenyl]-N-(4- fluorophenyl)- mono((2S)-2-hydroxybutanedioate)
1140909-48-3
2296AH
942407-59-2
AC-27471
AK323724
AKOS025401945
BMS907351
C28H24FN3O5.C4H6O5
Cabometyx
Cabozantinib (S-malate)
cabozantinib (S)-malate
cabozantinib L-malate
Cabozantinib L-Malate Salt
Cabozantinib malate
Cabozantinib malate (JAN)
Cabozantinib malate (XL184)
Cabozantinib s-malate (USAN)
Cabozantinib s-malate [USAN]
Cabozantinib(S-malate)
CHEBI:72319
CHEMBL2103868
Cometriq
Cometriq (TN)
CS-0201
cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinoline-4-yloxy)-phenyl]-amide(4-fluoro-phenyl)-amide, (S) malate salt
D10095
DR7ST46X58
HFCFMRYTXDINDK-WNQIDUERSA-N
HY-12044
KB-75860
KS-00000LA2
MLS006010951
MolPort-035-395-744
N-(4-((6,7-dimethoxyquinolin-4-yl)oxy)phenyl)-N-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (S)-2-hydroxysuccinate
N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluorophenyl)-1,1-cyclopropanedicarboxamide (2S)-2-Hydroxybutanedioic Acid
N-{4-[(6,7-dimethoxyquinolin-4-yl)oxy]phenyl}-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide (2S)-2-hydroxybutanedioate
s4001
SB17293
SC-91041
SMR004702755
SW218093-2
UNII-DR7ST46X58
W-5841
XL184(Cabozantinib malate)

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   See Pricing   See Pricing   See Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No   See Pricing   See Pricing   See Pricing
>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 CR 2014 00039 Denmark   See Pricing PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
2213661 C 2014 036 Romania   See Pricing 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 122014000091 Germany   See Pricing PRODUCT NAME: CABOZANTINIB UND JEDES THERAPEUTISCHE AEQUIVALENT HIERVON WIE DURCH DAS GRUNDPATENT GESCHUETZT, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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