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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 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:	150
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	49
Clinical Trials:	33
Patent Applications:	1
Drug Prices:	Drug price information for CABOMETYX
DailyMed Link:	CABOMETYX at DailyMed

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)

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

International Patents for CABOMETYX

Country	Patent Number	Estimated Expiration
Singapore	10201609324U
Japan	2011042686
Australia	2018220045
Japan	2013531045
Cyprus	1111956
Japan	2007506777

Supplementary Protection Certificates for CABOMETYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92508	Luxembourg		PRODUCT NAME: CABOZANTINIB ET TOUTES LES FORMES THERAPEUTIQUEMENT EQUIVALENTES QUI EN DERIVENT TELLES QUE PROTEGEES PAR LE BREVET DE BASE, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140326
2213661	43/2014	Austria		PRODUCT NAME: CABOZANTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/890/001-003 (MITTEILUNG) 20140326
2213661	C 2014 036	Romania		PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003; DATE OF FIRST AUTHORISATION IN EEA: 20140321
2213661	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2213661	C300678	Netherlands		PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326