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 ninety 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 January 15, 2030. This may change due to patent challenges or generic licensing.

There have been sixteen 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:	190
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	55
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:

11,091,439

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 11,091,439.

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
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes	9,717,720		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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

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
Argentina	075025	SALES DE MALATO DE N-(4-((6,7-BIS(METILOXI) QUINOLIN-4-IL) OXI)FENIL)-N'-(4-FLUOROFENIL) CICLOPROPAN-1,1-DICARBOXAMIDA Y FORMAS CRISTALINAS DE LAS MISMAS
Australia	2010204619	Malate salt of N-(4-{ [ 6, 7-bis (methyloxy)-quinolin-4-yl] oxy}phenyl)-N'-(4-fluorophenyl) cyclopropane-1,1-dicarboxamide, and crystalline forms therof for the treatment of cancer
Australia	2013203780	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
Australia	2016262732	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
Brazil	PI1006812	sal de malato de n-(4-{[6,7-bis(metiloxi)quinolin-4-il]fenil)-n-(4-fluorofenil)ciclopropane-1,1-dicarboxamida
Canada	2758030	SEL DE MALATE DE N-(4-{[6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY}PHENYL)-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE ET FORMES CRISTALLINES DE CELUI-CI POUR LE TRAITEMENT DU CANCER (MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUIN0LIN-4-YL]OXY}PHENYL-N'-(4-FLUOROPHENYL) CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEROF FOR THE TREATMENT OF CANCER)
Canada	2995880	SEL DE MALATE DE N-(4-{[6,7-BIS(METHYLOXY)QUINOLIN-4-YL]OXY}PHENYL-N'-( 4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE ET FORMES CRISTALLINES DE CELUI-CI POUR LE TRAITEMENT DU CANCER (MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUIN0LIN-4-YL]OXY}PHENYL-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEROF FOR THE TREATMENT OF CANCER)

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	C300678	Netherlands		PRODUCT NAME: CABOZANTINIB EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	CA 2014 00039	Denmark		PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 20140321
2213661	PA2014033	Lithuania		PRODUCT NAME: CABOZANTINIBUM; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321
2213661	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014
2213661	1490053-4	Sweden		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 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
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

COMETRIQ (cabozantinib): Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

COMETRIQ is a brand of cabozantinib used in oncology. Financial trajectory is dominated by (1) U.S. label scope and penetration in differentiated thyroid cancer (DTC) and metastatic medullary thyroid cancer (mMTC), (2) competitive intensity from other kinase inhibitors and immuno-oncology-adjacent regimens, and (3) payer behavior shaped by high WAC pricing and narrow clinical use. The market has expanded from a single oncology niche into broader cabozantinib franchise dynamics, but COMETRIQ-specific revenue growth depends on ongoing access, utilization, and patient share rather than broad, cross-tumor adoption.

What is COMETRIQ’s product-market role?

COMETRIQ (cabozantinib) is an oral targeted oncology therapy. Its market role is defined by where cabozantinib is positioned within standard-of-care pathways:

• Differentiated thyroid cancer (DTC), post-VEGFR-refractory: COMETRIQ is used after progression on VEGFR-directed therapy.
• Metastatic medullary thyroid cancer (mMTC): COMETRIQ is a backbone option in later-line and commonly earlier-line adoption depending on region and patient selection.

Cabozantinib’s commercial dynamics are closely tied to how quickly lines of therapy adopt TKIs and how strictly payers require documentation of prior VEGFR therapy for DTC. This creates a “conditional demand” profile: demand scales with new diagnoses entering eligible treatment windows and with competitive displacement rates from alternative TKIs.

How do market dynamics shape uptake and pricing power?

COMETRIQ’s market uptake is driven by three structural forces:

1) Label gating and real-world eligibility

• DTC requires prior VEGFR therapy. This gates eligible patient pools and delays new start growth.
• mMTC is clinically established, but adoption depends on patient genetics, timing of diagnosis, and provider familiarity.

This gating effect typically lowers the slope of category growth versus multi-line, broad-label oncology drugs.

2) Competition in the cabozantinib-adjacent TKI landscape

COMETRIQ competes in kinase inhibitor classes where substitution is common at progression. That raises “stickiness risk”:

• Patients move between TKIs with similar monitoring burdens.
• Payers prefer cost-effective regimens through step edits and prior authorization.

3) Payer economics: high WAC, net-price compression pressure

Oral oncology therapies face aggressive contracting dynamics, especially under Medicaid and commercial PBM formularies. Net pricing depends on:

• Rebate structures tied to utilization
• Evidence requirements for label-specific coverage
• Patient support program impact on adherence and persistence

Given cabozantinib’s chronic use pattern in oncology, payer contracting strongly affects realized revenue more than headline list price.

What is the financial trajectory path for COMETRIQ?

COMETRIQ’s financial trajectory generally follows a “franchise” pattern for cabozantinib products: initial growth on label expansion and penetration, then stabilization under competitive and payer pressure, with continued performance supported by pipeline of expanded indications and broader cabozantinib utilization.

In the public domain, the most reliable view of trajectory is through:

• Bayer’s and partners’ stated performance of cabozantinib-containing franchises
• SEC filings that describe revenue streams from cabozantinib products
• Regulatory and commercial milestones that shift eligibility or ordering behavior

Key trajectory inflection points

The market trajectory typically changes when at least one of the following occurs:

• New indication approvals that expand eligible patient populations
• Updated clinical guidelines that shift treatment sequencing toward or away from cabozantinib
• Formulary and contracting shifts that alter access (step edits, PA criteria, specialty pharmacy routing)
• Safety/management developments that reduce discontinuations and improve persistence

COMETRIQ’s growth has been most sensitive to label eligibility in thyroid cancer and to payer access constraints, not to broad first-line mainstream adoption.

How does the broader cabozantinib franchise influence COMETRIQ results?

COMETRIQ does not behave as an isolated asset. Cabozantinib’s overall franchise dynamics influence channel economics and payer positioning. When cabozantinib is positioned as a “family” option across tumor types, health plans may:

• Negotiate at the molecule level
• Apply formulary tier decisions across indications
• Standardize prior authorization criteria

This can either help COMETRIQ via shared payer acceptance or hurt it via cross-indication cost containment.

What do market drivers imply for forward revenue outlook?

Forward performance is most sensitive to:

1. Persistence and dosing tolerability
   Cabozantinib treatment is ongoing until progression or unacceptable toxicity. Any reduction in dose interruptions or discontinuations can improve net units and revenue per treated patient.

2. Access execution in DTC
   The “prior VEGFR therapy” requirement can cause coverage delays and reduce uptake if documentation burden rises. Faster access increases initial prescriptions and therapy start counts.

3. Competitive displacement rates
   In TKI-rich segments, gains depend on share at progression rather than only at diagnosis. If other agents become preferred after specific line criteria, COMETRIQ’s subsequent-line share can compress.

4. Contracting and rebate pressure
   As utilization matures, net prices usually face renewed pressure. That typically caps margin growth even if prescriptions rise.

Where does COMETRIQ sit in the oncology pricing landscape?

COMETRIQ is a specialty oral oncology therapy with high per-patient monthly cost. Pricing power depends on:

• How strictly payers enforce label criteria
• Whether clinicians can document prior therapies efficiently
• Whether patient support programs reduce out-of-pocket friction without creating adverse formulary policy responses

High-cost oncology drugs often see net price erosion over time even when prescription volume grows.

Financial trajectory summary: what typically happens over time

A COMETRIQ-like specialty oncology pattern is usually:

• Early market expansion after approvals and early adoption
• Penetration growth driven by guideline adoption and provider familiarity
• Stabilization as eligible pools saturate and payer restrictions intensify
• Renewed shifts when clinical practice updates or label expansions occur

Key Takeaways

• COMETRIQ’s market is thyroid oncology with strong label gating in DTC and established adoption in mMTC, creating “conditional demand” rather than broad-based growth.
• Competitive TKI substitution and payer access controls dominate performance after initial uptake.
• The cabozantinib franchise affects COMETRIQ net economics through molecule-level contracting and formulary decisions.
• Forward trajectory depends more on access execution, persistence, and contracting than on raw list-price dynamics.

FAQs

1. What limits COMETRIQ’s addressable market growth in differentiated thyroid cancer?
   Coverage typically requires prior VEGFR-directed therapy, narrowing the eligible pool.

2. Why does payer policy matter disproportionately for COMETRIQ?
   High-cost oral oncology drives step edits, prior authorization, and evidence requirements that can slow therapy starts and reduce persistence.

3. Does COMETRIQ compete primarily with other TKIs?
   Yes. Treatment switching at progression is common across kinase inhibitors in thyroid cancer settings.

4. How does tolerance affect COMETRIQ revenue?
   Better management of adverse events supports persistence and reduces discontinuations, which increases total treated patient-days and net units.

5. How can label or guideline changes alter COMETRIQ financials?
   Approvals and guideline sequencing changes expand eligible use or shift line placement, which impacts both prescription volume and access friction.

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References

[1] U.S. Food and Drug Administration. “COMETRIQ (cabozantinib) Prescribing Information.” FDA.
[2] U.S. Food and Drug Administration. “FDA Approval Letters and Labeling History for COMETRIQ (cabozantinib).” FDA.
[3] Bayer AG. Annual Report and Form 20-F financial statements covering cabozantinib product performance.
[4] U.S. Securities and Exchange Commission (SEC). Bayer filings describing oncology segment and cabozantinib-related revenue performance.

DrugChatter Q&A for COMETRIQ

Cometriq accelerated approval date?