Cabozantinib s-malate - Generic Drug Details

What are the generic sources for cabozantinib s-malate and what is the scope of freedom to operate?

Cabozantinib s-malate is the generic ingredient in two branded drugs marketed by Exelixis and Exelixis Inc, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabozantinib s-malate has two hundred and thirty-one patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for cabozantinib s-malate

International Patents:	231
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	41
Patent Applications:	1,299
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabozantinib s-malate
DailyMed Link:	cabozantinib s-malate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cabozantinib s-malate

Dosage:

CAPSULE;ORAL

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.

Recent Clinical Trials for cabozantinib s-malate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2/Phase 3
Children's Oncology Group	Phase 2/Phase 3
OHSU Knight Cancer Institute	Phase 2

See all cabozantinib s-malate clinical trials

Pharmacology for cabozantinib s-malate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for CABOZANTINIB S-MALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CABOMETYX	Tablets	cabozantinib s-malate	20 mg, 40 mg and 60 mg	208692	1	2019-08-16

US Patents and Regulatory Information for cabozantinib s-malate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y
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	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
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	208692-003	Apr 25, 2016		RX	Yes	Yes

International Patents for cabozantinib s-malate

Country	Patent Number	Title	Estimated Expiration
Slovenia	2210607
Canada	2805645	COMPOSITIONS PHARMACEUTIQUES MODULATRICES DE C-MET (C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
South Korea	20180056807	C-MET 조절제 약제학적 조성물 (C-MET C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2005030140
Japan	2016188216	キノリン化合物およびそのような化合物を含有する医薬組成物の調製方法 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
South Korea	20230008268	암의 치료를 위한 Ｎ-（４-｛〔６，７-비스（메틸옥시）퀴놀린-4-일〕옥시｝페닐）-Ｎ＇-（４-플루오로페닐）사이클로프로판-1,1-디카르복사미드의 말산염 및 그 결정형 (----4-----11- MALATE SALT OF N-4-[67-BISMETHYLOXYQUINOLIN-4-YL]OXYPHENYL-N'-4-FLUOROPHENYLCYCLOPROPANE-11-DICARBOXAMIDE AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER)
Taiwan	201920110	Pharmaceutical composition comprising malate salt of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide and use thereof

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2014/052	Ireland		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 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	132014902289810	Italy		PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 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	C 2014 036	Romania		PRODUCT NAME: CABOZANTINIB SI ORICE FORMA ECHIVALENTA TERAPEUTIC AACESTUIA, INCLUSIV SARURILE ACCEPT 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 ABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/890/001, EU/1/13/890/002, EU/1/13/890/003;