CABOZANTINIB S-MALATE - Generic Drug Details

What are the generic drug 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 Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes				Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	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

International Patents for CABOZANTINIB S-MALATE

Country	Patent Number	Title	Estimated Expiration
Singapore	10201609324U	C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS
Taiwan	I511956
Australia	2021205066	c-Met modulators and method of use
European Patent Office	4014971	COMPOSITIONS PHARMACEUTIQUES MODULATRICES DE C-MET (C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
Poland	2673262
Eurasian Patent Organization	030435	ТАБЛЕТКА, СОДЕРЖАЩАЯ МОДУЛЯТОР c-MET В ФОРМЕ КРИСТАЛЛИЧЕСКОЙ L-МАЛАТНОЙ СОЛИ (ВАРИАНТЫ), СПОСОБ ЕЕ ПРОИЗВОДСТВА И СПОСОБ ЛЕЧЕНИЯ ОНКОЛОГИЧЕСКОГО ЗАБОЛЕВАНИЯ С ЕЕ ИСПОЛЬЗОВАНИЕМ (TABLET COMPRISING c-MET MODULATOR IN THE FORM OF CRYSTALLINE L-MALATE SALT (EMBODIMENTS), PROCESS FOR MANUFACTURING SAME AND METHOD FOR TREATING CANCER USING SAME)

Supplementary Protection Certificates for CABOZANTINIB S-MALATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	SPC/GB14/052	United Kingdom		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/13/890/001-006 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	1490053-4	Sweden		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326
2213661	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
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