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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Fuji
Cerilliant
Chubb
Colorcon
Baxter
Chinese Patent Office

Generated: July 15, 2018

DrugPatentWatch Database Preview

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 cabozantinib s-malate 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabozantinib s-malate has one hundred and fifty patent family members in twenty-eight countries.

There is one drug master file entry for cabozantinib s-malate. One supplier is listed for this compound.
Summary for cabozantinib s-malate
International Patents:150
US Patents:5
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 37
Clinical Trials: 16
Patent Applications: 1
DailyMed Link:cabozantinib s-malate at DailyMed
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
AKOS025401945
BMS907351
C28H24FN3O5.C4H6O5
Cabometyx
Cabozantinib (S-malate)
cabozantinib (S)-malate
cabozantinib L-malate
Cabozantinib L-Malate Salt
Cabozantinib malate
Cabozantinib malate (XL184)
Cabozantinib s-malate (USAN)
Cabozantinib s-malate [USAN]
Cabozantinib(S-malate)
CHEBI:72319
CHEMBL2103868
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
MFCD20923480
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
SC-91041
SMR004702755
UNII-DR7ST46X58
W-5841
XL-184

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 208692-002 Apr 25, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-002 Apr 25, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Exelixis COMETRIQ cabozantinib s-malate CAPSULE;ORAL 203756-001 Nov 29, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for cabozantinib s-malate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,809,549 Malate salt of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'(4-fluorophenyl)cycl- opropane-1,1-dicarboxamide, and crystalline forms therof for the treatment of cancer ➤ Sign Up
2,014,155,378 ➤ Sign Up
8,067,436 c-Met modulators and methods of use ➤ Sign Up
8,178,532 c-Met modulators and method of use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for cabozantinib s-malate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000091 Germany ➤ Sign Up 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
0140029 00117 Estonia ➤ Sign Up PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
0 50007-2014 Slovakia ➤ Sign Up PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2014 00039 Denmark ➤ Sign Up PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Mallinckrodt
Cerilliant
Deloitte
Boehringer Ingelheim
McKesson
Fuji
Farmers Insurance
UBS

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