CABOMETYX Drug Patent Profile

Which patents cover Cabometyx, and what generic alternatives are available?

Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in CABOMETYX 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 Cabometyx

Cabometyx 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 fifteen 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 CABOMETYX

International Patents:	237
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	85
Patent Applications:	2,126
Drug Prices:	Drug price information for CABOMETYX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABOMETYX
What excipients (inactive ingredients) are in CABOMETYX?	CABOMETYX excipients list
DailyMed Link:	CABOMETYX at DailyMed

See drug prices for CABOMETYX

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

Constraining patent/regulatory exclusivity:

11,298,349

NDA:

208692

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 CABOMETYX

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

Sponsor	Phase
Jun Zhang, MD, PhD	Phase 2
Kura Oncology, Inc.	Phase 1
Mirati Therapeutics Inc.	Phase 1

See all CABOMETYX clinical trials

Pharmacology for CABOMETYX

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for CABOMETYX

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 CABOMETYX

CABOMETYX is protected by twenty US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,298,349.

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 Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	11,091,439			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No	10,039,757
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	11,091,440		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	10,034,873
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016		RX	Yes	Yes	11,298,349		Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No	10,039,757

Expired US Patents for CABOMETYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016	8,497,284

International Patents for CABOMETYX

When does loss-of-exclusivity occur for CABOMETYX?

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 CABOMETYX around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20210147117	퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Spain	2402524
Brazil	PI1006812
South Africa	201306072	PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS
South Korea	20200029633	C-MET 조절제 약제학적 조성물 (C-MET C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
South Korea	20200137052

Supplementary Protection Certificates for CABOMETYX

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

Market Dynamics and Financial Trajectory for CABOMETYX (Cabozantinib)

Last updated: July 27, 2025

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Introduction

CABOMETYX (cabozantinib) is an oral tyrosine kinase inhibitor (TKI) developed and marketed by Exelixis, Inc., primarily for the treatment of advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and other solid tumors. Its unique mechanism of targeting multiple pathways, including MET, VEGFR, and AXL, has positioned CABOMETYX as a significant player in targeted oncology therapies. Understanding its market dynamics and financial trajectory is crucial for stakeholders aiming to grasp its growth prospects and competitive landscape.

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Market Dynamics

1. Therapeutic Indications and Market Expansion

CABOMETYX’s initial approval in 2016 for advanced RCC, particularly in patients resistant to VEGF-targeted therapies, laid the foundation for its commercial success [1]. Subsequently, expanded approvals have broadened the label:

• Hepatocellular Carcinoma (HCC): In 2018, the FDA granted accelerated approval for adult patients with contraindications to sorafenib, acknowledging cabozantinib’s potential in this patient segment [2].
• Other solid tumors: Trials in medullary thyroid carcinoma (MTC) and other indications are ongoing or planned, offering future expansion opportunities.

The diversification across indications enhances CABOMETYX’s revenue streams, but also introduces variability in market size and competitive pressures.

2. Competitive Landscape

CABOMETYX faces competition from several oncology agents:

• Renal Cell Carcinoma: Key competitors include nivolumab plus cabozantinib (Tradename: CheckMate 9ER), which combines immune checkpoint blockade with TKI therapy [3]. This combination has shown superior progression-free survival (PFS).
• Hepatocellular Carcinoma: Sorafenib and lenvatinib remain standard of care, but cabozantinib’s approval offers an alternative, especially for patients intolerant to or progressing on sorafenib.
• Other TKIs: Agents like sunitinib and pazopanib compete in RCC, whereas regorafenib challenges cabozantinib’s position.

The growth of combination therapies and immuno-oncology developments intensifies competitive pressures and necessitates continual clinical and marketing strategies.

3. Market Penetration and Adoption

Initial uptake of CABOMETYX was moderate, influenced by factors including:

• Physician familiarity with TKIs and resistance to switching therapy.
• Approval of combination regimens (e.g., nivolumab + cabozantinib) which often outsell monotherapies owing to superior efficacy.
• Cost considerations and insurance coverage, which influence prescribing patterns.

Recent clinical data reinforcing CABOMETYX’s efficacy in front-line settings and in combination regimens can foster increased adoption, especially in the RCC segment.

4. Regulatory and Pricing Environment

Pricing strategy and reimbursement policies significantly influence revenue potential:

• Pricing: CABOMETYX is positioned as a premium therapy, often priced higher than earlier-generation TKIs.
• Reimbursement: Favorable insurance coverage and inclusion in formularies enhance patient access but may vary across regions and payers.

Regulatory developments such as label expansion or additional approvals could further impact market size, clinical utilization, and overall revenue.

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Financial Trajectory

1. Revenue Trends and Growth Drivers

Exelixis reports revenues primarily from CABOMETYX sales and licensing deals. Key financial influences include:

• Market penetration rates in RCC and HCC.
• Adoption of combination therapies incorporating CABOMETYX.
• Pricing adjustments driven by reimbursement negotiations and competitive pressures.

In recent years, revenues from CABOMETYX have shown steady growth, supported by expanding indications and increased physician acceptance [4].

2. Impact of Clinical Trials and Label Expansions

Positive phase III trial results and regulatory approvals have bolstered confidence in CABOMETYX’s utility. For example:

• The CELESTIAL trial demonstrated improved overall survival in HCC, influencing label updates and clinician prescribing habits [5].
• Ongoing studies in thyroid and other tumors could expand further indications, contributing to future sales growth.

Conversely, negative or inconclusive trial outcomes could diminish growth prospects and impact valuations.

3. Strategic Collaborations and Licensing Deals

Exelixis has entered multiple partnerships to boost market access, such as collaborations with Ipsen for European distribution, which aid in expanding geographical reach [6].

Licensing agreements providing upfront payments, milestones, and royalties diversify revenue streams but also introduce revenue variability depending on sales performance and ongoing R&D investments.

4. Cost Structure and Investment

Investments in clinical development, manufacturing, and marketing are substantial. While these costs suppress near-term profitability, they are essential for sustaining growth and expanding the pipeline.

As commercial sales increase, economies of scale and improved operational efficiencies are expected to enhance profit margins over the medium term.

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Future Outlook

1. Emerging Markets and Regional Expansion

Growth beyond established markets (U.S., EU, Japan) can significantly impact revenue. Mexico, China, and other Asia-Pacific regions represent sizable growth opportunities, contingent upon regulatory approvals and reimbursement landscapes.

2. Combination and First-line Therapies

The integration of CABOMETYX into combination regimens remains a pivotal driver. The success of trials such as CheckMate 9ER (with nivolumab) and other phase III studies will influence future market share and pricing strategies.

3. Pipeline and Innovation

Development of next-generation TKIs, or drugs targeting complementary pathways, could pose competitive threats or provide avenues for synergistic growth. Ongoing clinical trials explore combinations, dosing, and new indications, with potential impacts on market trajectory.

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Key Takeaways

• Strategic Positioning: CABOMETYX's strengths derive from its multi-pathway targeting, expanding indications, and positive clinical data, establishing a solid base in RCC and HCC.
• Market Competition: Increasing competition from combination therapies, especially immune-oncology agents, necessitates continuous innovation and marketing efforts.
• Revenue Drivers: Adoption rates, clinical trial successes, regulatory approvals, and regional expansion will predominantly influence financial growth.
• Pricing and Access: Maintaining favorable reimbursement, alongside strategic partnerships, remains critical to maximizing sales amid a competitive landscape.
• Growth Outlook: Future revenues hinge on successful trial outcomes for combination therapies, new indications, and expanding into emerging markets.

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FAQs

1. How does CABOMETYX compare to its competitors in treating RCC?
CABOMETYX faces stiff competition from combination therapies like nivolumab plus cabozantinib, which has demonstrated superior efficacy in some trials [3]. While monotherapy remains relevant, combination regimens are gradually dominating treatment protocols.

2. What are the prospects for CABOMETYX in hepatocellular carcinoma?
The drug’s FDA accelerated approval in HCC provides a competitive edge, especially for patients contraindicated for sorafenib. Ongoing trials and real-world data may solidify its position, potentially leading to full approval and expanded indications.

3. How might future trials influence CABOMETYX’s market share?
Successful phase III results for combinations and novel indications could expand the therapeutic landscape. Conversely, negative trial outcomes could limit growth opportunities.

4. What regional factors impact CABOMETYX's market penetration?
Regulatory approvals, payer coverage, healthcare infrastructure, and pricing negotiations differ regionally, affecting accessibility. Emerging markets offer growth potential but pose regulatory and reimbursement challenges.

5. What is the outlook for CABOMETYX’s revenue in the next five years?
Projected growth depends on clinical success, competitive dynamics, and market expansion. Analysts forecast steady revenue increases, especially as combination therapies and new indications gain traction.

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References

[1] Exelixis, Inc. "Cabozantinib (CABOMETYX): U.S. Prescribing Information." 2022.
[2] FDA. "FDA Approves Cabozantinib for Liver Cancer." 2018.
[3] Motzer RJ, et al. "Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma." New England Journal of Medicine. 2021.
[4] Exelixis, Inc. "Q4 and Full Year 2022 Financial Results." 2023.
[5] Llovet JM, et al. "CELESTIAL: A Phase III Trial of Cabozantinib in Advanced Hepatocellular Carcinoma." Lancet Oncology. 2018.
[6] Exelixis. "Partnerships and Collaborations." 2022.