CABOMETYX Drug Patent Profile

When do Cabometyx patents expire, and when can generic versions of Cabometyx launch?

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	208692-001	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016	8,497,284
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	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
New Zealand	744309	C-met modulator pharmaceutical compositions
Argentina	085155
Australia	2016247044	C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS
Australia	2004275842	c-MET modulators and methods of use
South Africa	201300458	C-MET-MODULATOR PHARMACEUTICAL COMPOSITIONS
South Korea	20190042768	C-MET 조절제 약제학적 조성물 (C-MET C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for CABOMETYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	583	Finland
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	2014/052	Ireland		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
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

Market Dynamics and Financial Trajectory for CABOMETYX

Last updated: December 27, 2025

Summary

CABOMETYX (cabozantinib) is an oral tyrosine kinase inhibitor developed by Exelixis, primarily targeted at advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), and other solid tumors. Since its FDA approval in 2016 for RCC and subsequent approvals for HCC and other cancers, CABOMETYX has experienced significant growth, driven by expansion into new indications, strategic partnerships, and increasing adoption in clinical practice. This analysis examines the key market drivers, competitive landscape, regulatory milestones, financial outlook, and strategic factors influencing CABOMETYX's trajectory over the coming years.

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1. Market Overview and Indication Expansion

1.1 Approved Indications and Labeling

Year	Indication	Regulatory Authority	Key Milestones
2016	Advanced Renal Cell Carcinoma	FDA	First approval based on the METEOR trial
2018	HCC (Post-Sorafenib)	FDA	Accelerated approval, later full approval in 2019
2021	Advanced RCC (First-line)	FDA	Approval based on CheckMate 9ER trial
2022	Medullary thyroid carcinoma (MTC)	FDA	Expanded label for progressive MTC

1.2 Current Market Size and Forecasts

• Renal Cell Carcinoma (RCC): 2022 global market estimated at ~$3.2 billion (source: GlobalData), expected to grow at a CAGR of 7% to reach ~$4.6 billion by 2030.
• Hepatocellular Carcinoma (HCC): ~$1.2 billion market in 2022, projected CAGR of 8%, reaching ~$2.3 billion by 2030.
• Other Indications: Emerging, including medullary thyroid carcinoma and prostate cancer, though current revenue contribution remains modest.

1.3 Drivers of Market Expansion

Driver	Impact	Details
Unmet Needs	High	Limited options for metastatic RCC and HCC after prior therapies
Approval of New Indications	High	First-line RCC (2021), MTC (2022)
Efficacy Data	Strong	METEOR, CheckMate 9ER, COSMIC-312 trials show positive outcomes
Combination Strategies	Growing	Ongoing trials combining CABOMETYX with immune checkpoint inhibitors

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2. Competitive Landscape and Market Share

2.1 Key Competitors

Company	Lead Products	Therapeutic Focus	Market Share (2022)	Competitive Advantage
Bayer/Regeneron	Nexavar (sorafenib), Lenvima (lenvatinib)	TKIs for RCC/HCC	~35%	Established in first-line treatment, strong branding
Bristol-Myers Squibb	Opdivo (nivolumab)	Immunotherapy	~25%	Superior OS in combination therapies
Exelixis (CABOMETYX)	CABOMETYX (cabozantinib)	TKIs	Estimated 15-20% (2022)	Versatile across multiple indications, combination potential

2.2 Market Penetration Strategies

• Combination approvals with immune checkpoint inhibitors (e.g., nivolumab + CABOMETYX in RCC and HCC).
• Geographic expansion into Asia-Pacific and Europe, where regula­tory authorities have granted approval.
• Clinical trial pipeline targeting additional tumor types and earlier treatment settings.

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3. Regulatory Milestones and Policy Environment

3.1 Recent and Pending Approvals

Date	Region	Indication	Status	Notes
2022 Q1	FDA	MTC	Approved	Elevated treatment options for MTC patients
2022 Q3	EMA	HCC	Approved	Lar­ger patient base, different dosing guidelines

3.2 Policy Trends Influencing Market Dynamics

• Pricing and Reimbursement: Progressive tightening in some markets (e.g., Europe) could limit revenue growth without demonstrating significant improvements over competitors.
• Orphan Drug Designation: For MTC and other rare indications, providing long-term exclusivity advantages.
• Expedited Pathways: Accelerated approvals for promising indications, shortening time to market.

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4. Financial Trajectory and Revenue Projections

4.1 Revenue Drivers and Assumptions

Factor	Assumption	Impact
Market Penetration	Increasing adoption up to 40% in approved indications	Drives revenue growth
Pricing	Average wholesale price (AWP) ~$12,000/month	Monetization per patient
Combination Therapy Revenue	50% of new patients receive combination therapy	Significant upside
Geography	70% of revenue from US and Europe, 30% from APAC	Diversification risks

4.2 Revenue Forecast Table (2023–2032)

Year	Revenue (USD billion)	CAGR	Key Factors
2023	0.95	—	Adoption steady, new approvals ongoing
2025	1.50	16%	Expanded indications, increased combo use
2027	2.10	15%	Market saturation, new tumor types
2030	3.00	10%	Mature market, competitive pressures
2032	3.50	8%	New indications, geographic expansion

4.3 Profitability Outlook

• Gross margins estimated at 80%, driven by oral formulation and scalable manufacturing.
• Operating costs forecasted to rise with expanded clinical development (~USD 200–300 million annually after 2025).
• EBITDA margins projected at 35–40% by 2030, assuming successful commercialization strategies.

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5. Strategic Opportunities and Risks

5.1 Opportunities

Opportunity	Description	Potential Impact
Combination Regimens	Partner with major immunotherapy providers	Increased adoption, higher margins
Expansion into New Cancers	Invest in trials for lung, prostate, melanoma	Diversification, revenue boost
Global Market Access	Focus on APAC growth	Large patient volumes, higher sales

5.2 Risks

Risk	Description	Mitigation Strategies
Intense Competition	Entry of new TKIs and immunotherapies	Continuous innovation, pipeline expansion
Regulatory Delays	Approval setbacks in key markets	Early regulatory engagement
Pricing Pressures	Reimbursement restrictions	Demonstrate clinical value, health economics data

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6. Comparative Analysis of Key Competitors

Parameter	CABOMETYX	Nivolumab + Ipilimumab	Lenvatinib + Pembrolizumab	Sorafenib
FDA Approval Year	2016	2018/2017	2019	2005
Primary Indication (RCC)	Yes	Yes (in combo)	Yes (in combo)	Yes
Market Share (2022)	15-20%	25%	20%	30%
Pricing (USD/month)	$12,000	$14,000 (combo)	$13,000	$10,000
Efficacy (OS improvement vs. control)	Median OS: 16.6 months (METEOR)	Conflicting data, but durable responses	Targeted for rapid approval	Median OS: 20 months

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Conclusion: Key Drivers for CABOMETYX’s Future Growth

• The expansion into first-line RCC and approval in HCC significantly broaden its revenue base.
• Strategic partnerships, especially in combination immunotherapy regimens, are pivotal.
• The growing global burden of RCC, HCC, and rare tumors underpins sustained demand.
• Competition remains intense, requiring continuous innovation and evidence generation.
• Operational excellence, cost management, and geographic expansion are critical for maximizing financial trajectory.

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Key Takeaways

• Market Expansion: CABOMETYX’s timely indication approvals and combination strategies underpin sustained growth.
• Competitive Positioning: Maintaining differentiation through clinical data and genomic targeting is vital against entrenched competitors.
• Financial Outlook: Expect a compound annual growth rate of approximately 8–10% in revenues through 2030, driven by new indications and global adoption.
• Strategic Focus: Diversifying indications, optimizing pricing strategies, and expanding into emerging markets will be decisive.
• Risks & Mitigation: Addressing competition, regulatory resilience, and reimbursement challenges through robust clinical evidence is essential.

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5 Unique FAQs

Q1: How does CABOMETYX differentiate from other tyrosine kinase inhibitors?
CABOMETYX is distinguished by its broad kinase inhibition profile, targeting MET, VEGFR, AXL, and RET, which confers efficacy across multiple tumor types and resistance mechanisms. Its oral administration and favorable safety profile also enhance patient adherence.

Q2: What is the outlook for combination therapies involving CABOMETYX?
Combination regimens with immune checkpoint inhibitors like nivolumab have demonstrated superior efficacy in RCC and HCC, providing a significant growth avenue. Ongoing trials are evaluating efficacy in additional cancers, promising further expansion.

Q3: What are the key regulatory hurdles for CABOMETYX's future approvals?
Regulatory agencies prioritize confirmed clinical benefits, safety, and real-world evidence. The challenge lies in demonstrating value in new indications, especially where competing standards of care exist. Expedited pathways can facilitate faster market access.

Q4: How might pricing pressures impact CABOMETYX’s revenue?
In regions with strict pricing controls, reductions could constrain revenue growth. However, value-based reimbursement models and demonstrated clinical benefits can mitigate pricing concerns.

Q5: What are the major risks associated with CABOMETYX’s long-term market success?
Increased competition, emergence of more effective therapies, regulatory setbacks, and reimbursement limitations pose significant risks. Strategic innovation, evidence generation, and market diversification are essential countermeasures.

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References

1. GlobalData, Cancer Market Reports, 2022.
2. U.S. Food and Drug Administration (FDA), Drug Approvals and Labeling, 2016–2022.
3. Exelixis Inc., Annual Reports and Investor Presentations, 2022.
4. Regulatory agencies' public documents and trial data summaries (EMA, FDA public databases).
5. Market research figures, Mordor Intelligence and IQVIA reports, 2022.

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