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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 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

International Patents:	132
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	95
Clinical Trials:	18
Patent Applications:	1
Drug Prices:	Drug price information for CABOMETYX
DailyMed Link:	CABOMETYX at DailyMed

Generic Entry Opportunity Date for CABOMETYX

NDA:

208692

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 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

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
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No			Y	Y

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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
2,014,155,378
9,174,947	c-Met modulators and methods of use
8,178,532	c-Met modulators and method of use

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International Patents for CABOMETYX

Country	Document Number	Estimated Expiration
Japan	2017160270
South Korea	20130137586
South Korea	20120013301
San Marino	T201300050

Supplementary Protection Certificates for CABOMETYX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014033,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
0 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2014000091	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
0678	Netherlands		PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326