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Last Updated: December 15, 2019

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Cabozantinib s-malate - Generic Drug Details

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What are the generic drug 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-nine 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
ExelisisPhase 2
ExelixisPhase 2
United States Department of DefenseN/A

See all cabozantinib s-malate clinical trials

Recent Litigation for cabozantinib s-malate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Exelixis, Inc. v. MSN Laboratories Private Limited2019-10-29

See all cabozantinib s-malate litigation

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)
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   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 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 Y Y   Start Trial
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-002 Nov 29, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 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   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 43/2014 Austria   Start Trial PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326
2213661 583 Finland   Start Trial
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
2213661 220 50007-2014 Slovakia   Start Trial PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2213661 C300678 Netherlands   Start 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 C02213661/01 Switzerland   Start Trial PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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