COMETRIQ Drug Patent Profile

Which patents cover Cometriq, and when can generic versions of Cometriq launch?

Cometriq is a drug marketed by Exelixis and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and eighty-two patent family members in thirty-two countries.

The generic ingredient in COMETRIQ 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.

DrugPatentWatch^® Generic Entry Outlook for Cometriq

Cometriq was eligible for patent challenges on November 29, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 10, 2032. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for COMETRIQ

International Patents:	182
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	169
Clinical Trials:	54
Patent Applications:	2,511
Drug Prices:	Drug price information for COMETRIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COMETRIQ
What excipients (inactive ingredients) are in COMETRIQ?	COMETRIQ excipients list
DailyMed Link:	COMETRIQ at DailyMed

See drug prices for COMETRIQ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for COMETRIQ

NDA:

203756

Dosage:

CAPSULE;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 COMETRIQ

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

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

See all COMETRIQ clinical trials

Pharmacology for COMETRIQ

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for COMETRIQ

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for COMETRIQ

COMETRIQ is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COMETRIQ

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	203756-001	Nov 29, 2012		RX	Yes	No			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y

International Patents for COMETRIQ

When does loss-of-exclusivity occur for COMETRIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

South Africa

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COMETRIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P20140563
Croatia	P20110707
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	20120013301	MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY}PHENYL)-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	300678	Netherlands		PRODUCT NAME: CABOZANTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/890/001-003 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	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
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