DrugPatentWatch Database Preview

CABOMETYX Drug Profile

Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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-eight 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.

US ANDA Litigation and Generic Entry Outlook for Cabometyx

Cabometyx was eligible for patent challenges on November 29, 2016.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for CABOMETYX

International Patents:	158
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	50
Clinical Trials:	42
Patent Applications:	1
Drug Prices:	Drug price information for CABOMETYX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABOMETYX
DailyMed Link:	CABOMETYX at DailyMed

See drug prices for CABOMETYX

Recent Clinical Trials for CABOMETYX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Health Network, Toronto	Phase 2
University of Washington	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2

See all CABOMETYX clinical trials

Recent Litigation for CABOMETYX

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Exelixis, Inc. v. MSN Laboratories Private Limited	2019-10-29

See all CABOMETYX litigation

Pharmacology for CABOMETYX

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein 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			Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No			Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No

International Patents for CABOMETYX

Country	Patent Number	Estimated Expiration
Australia	2010204459
Netherlands	300678
China	106083714
South Korea	20190042768
Canada	2805645
Taiwan	201920110

Supplementary Protection Certificates for CABOMETYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2213661	CR 2014 00039	Denmark		PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140326
2213661	122014000091	Germany		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
2213661	PA2014033	Lithuania		PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661	C02213661/01	Switzerland		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
2213661	PA2014033,C2213661	Lithuania		PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321