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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Deloitte
Harvard Business School
Express Scripts
US Army
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Generated: August 20, 2018

DrugPatentWatch Database Preview

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 four patents protecting this drug.

This drug has one hundred and thirty-two patent family members in twenty-eight countries.

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

Summary for CABOMETYX
Drug patent expirations by year for CABOMETYX
Generic Entry Opportunity Date for CABOMETYX
Generic Entry Date for CABOMETYX*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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
AKOS025401945
BMS907351
C28H24FN3O5.C4H6O5
Cabozantinib (S-malate)
cabozantinib (S)-malate
cabozantinib L-malate
Cabozantinib L-Malate Salt
Cabozantinib malate
Cabozantinib malate (XL184)
Cabozantinib S-malate
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 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 208692-001 Apr 25, 2016 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Exelixis Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-003 Apr 25, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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 Inc CABOMETYX cabozantinib s-malate TABLET;ORAL 208692-001 Apr 25, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ 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 CABOMETYX

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
9,174,947 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 CABOMETYX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014033,C2213661 Lithuania ➤ Sign Up PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
0 50007-2014 Slovakia ➤ Sign Up PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
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
0678 Netherlands ➤ Sign Up PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION 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:

Queensland Health
Johnson and Johnson
Healthtrust
Julphar
Chubb
US Department of Justice
Teva
Federal Trade Commission
Mallinckrodt

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