Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Moodys
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McKesson
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Johnson and Johnson

Last Updated: December 9, 2019

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CABOMETYX Drug Profile

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When do Cabometyx patents expire, and when can generic versions of Cabometyx launch?

Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and fifty-six patent family members in twenty-nine countries.

The generic ingredient in CABOMETYX is cabozantinib s-malate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabozantinib s-malate profile page.

Drug patent expirations by year for CABOMETYX
Drug Prices for CABOMETYX

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Recent Clinical Trials for CABOMETYX

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SponsorPhase
MedStar Franklin Square Medical CenterPhase 2
Georgetown UniversityPhase 2
Hackensack Meridian HealthPhase 2

See all CABOMETYX clinical trials

Recent Litigation for CABOMETYX

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

See all CABOMETYX litigation

Pharmacology for CABOMETYX
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for CABOMETYX
(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
Cabozantinib (S-malate)
cabozantinib (S)-malate
cabozantinib L-malate
Cabozantinib L-Malate Salt
Cabozantinib malate
Cabozantinib malate (JAN)
Cabozantinib malate (XL184)
Cabozantinib S-malate
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 CABOMETYX
Tradename Dosage Ingredient NDA Submissiondate
CABOMETYX TABLET;ORAL cabozantinib s-malate 208692 2019-08-16

US Patents and Regulatory Information for CABOMETYX

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 208692-003 Apr 25, 2016 RX Yes Yes   Start Trial   Start Trial   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 Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes   Start Trial   Start Trial   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 Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No   Start Trial   Start Trial Y Y   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 CABOMETYX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
2213661 14C0067 France   Start Trial PRODUCT NAME: CABOZANTINIB ET TOUTE FORME THERAPEUTIQUEMENT EQUIVALENTE COUVERTE PAR LE BREVET DE BASE,INCLUANT SES SELS PHARMACEUTIQUEMENT EQUIVALENTS.; REGISTRATION NO/DATE: EU/1/13/890 20140326
2213661 CA 2014 00039 Denmark   Start Trial PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661 C20140029 00117 Estonia   Start Trial PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Express Scripts
Johnson and Johnson
McKinsey
Moodys

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