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 eight patents protecting this drug.

This drug has one hundred and eighty-nine patent family members in thirty-one 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 fourteen 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:	189
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	55
Patent Applications:	5,712
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

Constraining patent/regulatory exclusivity:

9,717,720

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
National Cancer Institute (NCI)	Phase 2/Phase 3
Children's Oncology Group	Phase 2/Phase 3
Oregon Health and Science University	Phase 2

See all COMETRIQ clinical trials

Pharmacology for COMETRIQ

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for COMETRIQ

COMETRIQ is protected by eight US patents.

This potential generic entry date is based on patent 9,717,720.

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

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	8,877,776		Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No	7,579,473		Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No	11,091,440		Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes	11,091,440		Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No	9,717,720		Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes	7,579,473		Y	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
Slovenia	2387563
New Zealand	712808	Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Eurasian Patent Organization	201400110
Japan	6342456
Brazil	112013020362
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)

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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;
2213661	PA2014033	Lithuania		PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661	1490053-4	Sweden		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 20140326
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	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014

Market Dynamics and Financial Trajectory of COMETRIQ (Tivantinib): An In-Depth Analysis

Last updated: December 25, 2025

Summary

COMETRIQ (tivantinib), developed by ArQule Inc. and subsequently acquired by Eli Lilly, is an investigational oncology drug targeting MET (hepatocyte growth factor receptor) pathway dysregulation in cancer therapy. While its initial promise centered on treating hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC), clinical challenges and evolving therapeutic landscapes have significantly influenced its market trajectory. This analysis reviews the current market landscape, clinical development status, financial implications, and strategic considerations for COMETRIQ, providing insights vital for stakeholders.

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Introduction

Pharmaceuticals targeting specific oncogenic pathways have revolutionized cancer care. COMETRIQ was positioned as a targeted therapy focusing on MET dysregulation, involved in multiple tumor types. Since its inception, the drug's market potential has faced hurdles due to mixed clinical efficacy, regulatory decisions, and competitive factors.

This report explores:

• The molecular profile, clinical development, and approval status of COMETRIQ.
• Market dynamics influencing its commercial viability.
• Financial planning and projected trajectories.
• Competitive landscape and future outlook.

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What is COMETRIQ (Tivantinib)?

Attribute	Details
Drug Name	COMETRIQ (Tivantinib)
Developer	Originally ArQule, now Lilly
Mechanism of Action	Selective MET tyrosine kinase inhibitor (initially believed to be microtubule inhibitor)
Indications (Planned/Trials)	Primarily hepatocellular carcinoma (HCC), NSCLC, others
Approval Status	Not approved globally; received conditional/regulatory notifications

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Clinical and Regulatory History

Initial Promises and Trials

• Phase 3 Trials (METIV-HCC, METLIV-HCC): Designed to evaluate tivantinib in HCC patients with MET overexpression.
• Results: Mixed outcomes; some trials demonstrated progression-free survival improvements, but overall survival benefits remained inconclusive.

Regulatory Decisions

Jurisdiction	Decision & Rationale	Year
U.S. (FDA)	No NDA submitted; initial Phase 3 results insufficient for approval	N/A
Europe (EMA)	No approval; further evidence required	N/A
Japan	Approved in 2014 for specific cases under conditional approval (limited scope)	2014

Market Impact of Clinical Outcomes

• The inconclusive efficacy data prompted Lilly to reevaluate its strategic positioning.
• As of 2023, COMETRIQ remains investigational; no major regulatory approvals granted.

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Market Dynamics Influencing COMETRIQ

1. Competitive Oncology Landscape

Key Players & Drugs	Mechanism	Indications	Market Share (2023)
Atezolizumab + Bevacizumab	Immunotherapy + anti-angiogenic	HCC	~40%
Lenvatinib	Multi-kinase inhibitor	HCC	~25%
Sorafenib	Raf kinase inhibitor	HCC	~20%
Regorafenib	Multi-kinase inhibitor	HCC	~10%

Note: MET inhibitors (e.g., crizotinib, cabozantinib) are available for a subset of tumors but have limited indications in HCC.

2. Market Barriers

• Efficacy Discrepancies: Trials failed to demonstrate robust survival benefit.
• Biomarker Challenges: Suitable MET overexpression detection complicates patient stratification.
• Regulatory Hesitance: Lack of approval limits commercial deployment.
• Pricing & Reimbursement: Without approval, reimbursement schemes are absent, reducing market viability.

3. Clinical Trial Landscape

Trial Phase	Number of Trials (2023)	Focus
Phase 1	3	Safety profiling
Phase 2	4	Efficacy in solid tumors
Phase 3	2	Confirmatory efficacy in HCC

Note: The trials focus on alternative indications, such as gastric and lung cancers, with mixed results.

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Financial Trajectory and Strategic Outlook

Historical Financials

Year	R&D Spend (USD million)	Revenue (USD million)	Net Income (USD million)	Notes
2014	~$50	N/A	N/A	Post-approval in Japan
2017	~$100	N/A	N/A	Clinical development ramp-up
2020	~$80	N/A	N/A	Decline due to trial failures

Note: As COMETRIQ remains unapproved, revenue streams are limited, and the primary financial impact involves R&D investments.

Current Strategy & Investment Outlook

• License & Collaborate: Lilly’s strategic shift involves licensing or partnering of tivantinib for specific niches or research use.
• Pipeline Optimization: Trials focus on lung and gastric cancers with better biomarker stratification.
• R&D Expense Management: Continued clinical testing entails high R&D costs, with uncertain commercialization prospects.

Forecasted Financial Trajectory (Next 5 Years)

Scenario	Likelihood	Key Factors	Implications
Optimistic (Alternative Indications, Successful Trials)	Low	Positive trial outcomes, regulatory approval	Potential licensing revenue, market entry
Status Quo (Limited Trials, No Approval)	Moderate	Ongoing research, non-commercial use	R&D costs without significant revenue
Pessimistic (Trial Failures)	High	Insufficient efficacy, market decline	Asset write-downs, discontinuation

Note: Given current clinical outcomes, the baseline forecast suggests minimal market traction unless future trials demonstrate clear benefits.

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Competitive Landscape

Targeted MET Inhibitors	Approved Uses	Key Attributes	Market Penetration
Cabozantinib	HCC, medullary thyroid cancer	Multi-kinase inhibitor	Strong competitor
Crizotinib	ALK-positive lung cancer	MET inhibition	Niche player
Capmatinib	MET exon 14 skipping NSCLC	Selective MET inhaler	Emerging

COMETRIQ’s niche has narrowed due to these drugs' approvals and efficacy.

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Future Outlook and Strategic Considerations

Potential Niches & Opportunities

• Biomarker-Driven Precision Oncology: Identifying patient subsets with MET overexpression could reinvigorate COMETRIQ’s clinical relevance.
• Combination Therapies: Synergies with immunotherapies (e.g., checkpoint inhibitors) may open new avenues.
• Repurposing or Co-Development: Collaborations with biotech firms focusing on rare tumors or specific genetic profiles.

Risks & Challenges

• Clinical Efficacy Doubts: Overcoming past trial failures.
• Market Competition: Dominance of broader-spectrum kinase inhibitors.
• Regulatory Hurdles: Necessity for compelling data to seek approval.
• Pricing Pressure: Cost containment in oncology therapeutics.

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Key Takeaways

• COMETRIQ’s journey reflects the challenges of targeted oncology drug development: promising early data but inconclusive phase 3 results limit commercial prospects.
• Regulatory and clinical success depends heavily on robust biomarker stratification: without clear patient selection, future trials may struggle.
• Market competition is intense: existing approved MET inhibitors and multi-kinase drugs dominate the therapeutic landscape.
• Financial sustainability hinges on strategic partnerships: further clinical validation could carve niche markets, but risks remain high.
• Investors and stakeholders must monitor ongoing trials and biomarker developments: these could redefine COMETRIQ’s potential in precision medicine.

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FAQs

1. Why did COMETRIQ fail to achieve widespread approval?
Clinical trials yielded inconclusive data on survival benefits in HCC, compounded by challenges in patient stratification and competition from other approved therapies, limiting regulatory approval prospects.

2. Are there specific patient populations where COMETRIQ might still be effective?
Potentially, patients with confirmed MET overexpression or MET-driven tumors; however, definitive evidence remains forthcoming via ongoing research.

3. How does COMETRIQ compare to other MET inhibitors?
Unlike approved drugs like cabozantinib and capmatinib, COMETRIQ has not received regulatory approval due to lack of substantiated efficacy; it currently remains investigational.

4. What are the prospects of COMETRIQ in combination therapies?
Preliminary research suggests potential synergy with immunotherapies, but clinical validation is necessary, and trials are ongoing.

5. What’s the recommended strategic approach for stakeholders interested in COMETRIQ?
Focus on biomarker selection, monitor new clinical data, and explore partnerships targeting niche indications or combination strategies to maximize potential value.

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References

1. ArQule Press Releases & SEC Filings (2014-2022).
2. European Medicines Agency (EMA) Approval Documentation (2014).
3. ClinicalTrials.gov Database (Accessed 2023).
4. Lilly Corporate Portfolio & R&D Reports (2020-2023).
5. Market Reports on Oncology and Targeted Therapies (2023).

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Disclaimer: This analysis is for informational purposes and does not constitute investment advice.