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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.

Summary for CABOMETYX

International Patents:	156
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	49
Clinical Trials:	37
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
MedStar Franklin Square Medical Center	Phase 2
Georgetown University	Phase 2
Hackensack Meridian Health	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
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	208692-003	Apr 25, 2016		RX	Yes	Yes
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No			Y	Y

International Patents for CABOMETYX

Country	Patent Number	Estimated Expiration
Singapore	173014
Japan	5694501
Japan	5185332
Hong Kong	1164313
Spain	2371383

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	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
2213661	14C0067	France		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		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		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014