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

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
OHSU Knight Cancer Institute	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.

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			Y	Y
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	203756-002	Nov 29, 2012		RX	Yes	Yes			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			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
Australia	2022246429
Canada	2995880
Mexico	2011007620
South Korea	20230008268
Denmark	2213661

Supplementary Protection Certificates for COMETRIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	583	Finland
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	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: COMETRIQ

Last updated: July 27, 2025

Introduction
COMETRIQ (cabozantinib) is a targeted cancer therapy developed by Exelixis, primarily indicated for advanced medullary thyroid carcinoma (MTC) and renal cell carcinoma (RCC). Since its FDA approval in 2016 for advanced MTC and later expansion for RCC, COMETRIQ’s market performance has been influenced by evolving oncology treatment landscapes, patent status, competitive dynamics, and healthcare policy shifts. This analysis delineates the key market drivers, competitive environment, financial trends, and future outlook impacting COMETRIQ’s commercial trajectory.

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Market Overview and Therapeutic Context

COMETRIQ belongs to the class of tyrosine kinase inhibitors (TKIs) targeting multiple pathways involved in tumor progression, including VEGFR, MET, and AXL. Its approval was a significant milestone, offering a targeted option for patients with limited alternatives. The global focus on precision oncology and increasing incidence of RCC and MTC have been notable factors supporting its market relevance.

Indication Expansion and Off-label Use
Initially approved for progressive, metastatic MTC, COMETRIQ’s label expansion to include RCC enhanced its market scope. However, the therapeutic landscape in RCC has grown more crowded with the advent of combinations such as nivolumab with ipilimumab or cabozantinib with immunotherapies, potentially affecting COMETRIQ’s market share.

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Market Dynamics

1. Competitive Landscape
The oncology market for RCC and MTC is highly competitive. In RCC, several TKIs like sunitinib, pazopanib, and cabozantinib (another formulation) compete directly with COMETRIQ. The introduction of immune checkpoint inhibitors (e.g., nivolumab) and combination regimens has transformed treatment paradigms.[1] For MTC, limited options exist post-vemurafenib, but ongoing clinical trials and emerging therapies threaten COMETRIQ’s exclusivity.

2. Patent and Formulation Considerations
COMETRIQ’s patent protection benefits have been challenged, especially as drugs near patent expiry, risking generic or biosimilar entry. This dynamic influences pricing power and revenue stability. Although Exelixis holds patents until at least 2023-2024, legal challenges and patent cliff considerations loom.

3. Pharmacovigilance and Clinical Data
Real-world evidence and ongoing clinical trials affect perceptions of efficacy and safety. The drug's adverse effect profile, including diarrhea, hypertension, and fatigue, influences physician prescribing behavior amid competing therapies with more tolerable profiles.

4. Market Penetration and Reimbursement
Reimbursement policies significantly impact COMETRIQ’s market access. In developed markets, higher healthcare spending, formulary inclusion, and insurance coverage bolster sales. Conversely, in emerging markets, cost and access barriers limit uptake.

5. Regulatory and Policy Environment
Health authorities’ evolving stance on oncology drugs, approval of combination therapies, and emphasis on cost-effectiveness models influence COMETRIQ’s market viability. Post-approval, supplemental dosing, and label updates further shape its commercial prospects.

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Financial Trajectory Analysis

1. Revenue Trends
Since FDA approval, COMETRIQ has experienced fluctuating revenue streams. Initial rapid growth post-launch in 2016 was driven by unmet clinical needs. However, subsequent years saw plateauing or declining sales due to increased competition and treatment shifts toward combination regimens.

In 2021, Exelixis reported approximately $130 million in net sales for COMETRIQ, reflecting a modest decline compared to peak periods (above $200 million in 2017). This trend underscores the impact of market saturation and therapeutic alternatives.[2]

2. Impact of Patent and Formulation Changes
The impending patent expiration and potential biosimilar entries threaten future revenue streams. Price erosion margins have begun aligning with broader trends in oncology generics, necessitating strategic pivots.

3. R&D and Pipeline Prospects
Exelixis has invested in expanding its pipeline with next-generation MET inhibitors and combination studies. Progress in ongoing trials could bolster future revenue via label extensions or new indications. Nonetheless, these efforts entail substantial R&D spending, impacting short-to-medium-term financials.

4. Collaborative and Licensing Agreements
Partnerships with other pharma companies facilitate broader distribution. For instance, in Japan, commercialization agreements bolster COMETRIQ’s presence, impacting revenue positively in select markets.

5. Cost Dynamics
Manufacturing costs for small-molecule drugs like cabozantinib are relatively stable; however, expenses associated with regulatory compliance and clinical development influence overall profitability.

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Future Outlook and Strategic Considerations

1. Market Expansion and New Indications
Clinical trials exploring COMETRIQ in hepatocellular carcinoma (HCC) and combinations with immunotherapies could unlock additional revenue streams if approved. Such expansions depend heavily on trial outcomes and regulatory pathways.

2. Competitive Differentiation Strategies
Differentiation depends on demonstrating superior efficacy or tolerability compared to existing options. Personalized medicine approaches and biomarker-driven patient selection could improve market penetration.

3. Pricing and Reimbursement Strategies
Negotiating favorable reimbursement terms and engaging with payers to demonstrate cost-effectiveness remain vital. Value-based pricing models may support sustained revenue, especially amid erosion from generics.

4. Navigating Patent Challenges
Legal defenses against patent challenges and securing supplementary protections could delay generic entry, preserving revenue for a longer period.

5. Digital and Real-World Evidence
Investing in digital health strategies and real-world evidence collection can strengthen market positioning and support label updates or expanded indications.

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Key Takeaways

• Market Competition Is Intensifying: The rise of combination immunotherapies and alternative TKIs has compressed COMETRIQ’s market share. Strategic positioning and clinical differentiation are crucial.

• Patent and Pricing Pressures Are Real: Patent expirations and biosimilar threats necessitate proactive legal and commercial strategies to sustain profitability.

• Pipeline and Indication Expansion Are Pivotal: Continued investment in clinical trials for additional indications could offset revenue declines in established markets.

• Reimbursement and Access Drive Revenue Stability: Collaborations with payers and value-based pricing models can mitigate the impact of generic competition.

• Innovation in Data and Digital Health Will Shape Future Success: Robust real-world data and digital engagement are essential to demonstrate value and maintain market presence.

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FAQ

1. What are the primary competitors of COMETRIQ in its main indications?
In RCC, primary competitors include other TKIs such as sunitinib, pazopanib, and cabozantinib (different formulations). For MTC, options are limited, but emerging therapies targeting RET mutations may pose future competition. The rise of immun