cabozantinib s-malate - Profile

What are the generic sources for cabozantinib s-malate and what is the scope of freedom to operate?

Cabozantinib s-malate is the generic ingredient in two branded drugs marketed by Exelixis and Exelixis Inc, and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabozantinib s-malate has two hundred and thirty-eight patent family members in thirty-two countries.

Summary for cabozantinib s-malate

International Patents:	238
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabozantinib s-malate

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cabozantinib s-malate

Dosage:

CAPSULE;ORAL

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.

Paragraph IV (Patent) Challenges for CABOZANTINIB S-MALATE

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 cabozantinib s-malate

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
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No				Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y	Y

Expired US Patents for cabozantinib s-malate

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

International Patents for cabozantinib s-malate

Country	Patent Number	Title	Estimated Expiration
Taiwan	201546049	Method for preparing N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide
Eurasian Patent Organization	019959	МАЛАТНАЯ СОЛЬ N-(4-{[6,7-БИС-(МЕТИЛОКСИ)ХИНОЛИН-4-ИЛ]ОКСИ}ФЕНИЛ)-N'-(4-ФТОРФЕНИЛ)ЦИКЛОПРОПАН-1,1-ДИКАРБОКСАМИДА И ЕЕ КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ДЛЯ ЛЕЧЕНИЯ РАКА (MALATE SALT OF N-(4-{[6,7-BIS(METHYLOXY)QUIN0LIN-4-YL]OXY}PHENYL)-N'-(4-FLUOROPHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE, AND CRYSTALLINE FORMS THEREOF FOR THE TREATMENT OF CANCER)
Spain	2651730
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)
Georgia, Republic of	P20247677
Eurasian Patent Organization	201400110	МАЛАТНАЯ СОЛЬ N-(4-{[6,7-БИС-(МЕТИЛОКСИ)ХИНОЛИН-4-ИЛ]ОКСИ}ФЕНИЛ-N'-(4-ФТОРФЕНИЛ)ЦИКЛОПРОПАН-1,1-ДИКАРБОКСАМИДА И ЕЕ КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ДЛЯ ЛЕЧЕНИЯ РАКА (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)
World Intellectual Property Organization (WIPO)	2012009722

Supplementary Protection Certificates for cabozantinib s-malate

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	2014/052	Ireland		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/13/890/001-003 20140326
2213661	1490053-4	Sweden		PRODUCT NAME: CABOZANTINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/13/890 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	C02213661/01	Switzerland		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66471 15.12.2017
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;

Investment Scenario and Fundamentals Analysis for Cabozantinib s-Malate

Last updated: February 20, 2026

Cabozantinib s-malate is a tyrosine kinase inhibitor approved for multiple cancer indications. Its market presentation, pipeline prospects, and competitive landscape determine its investment appeal.

Market Overview

Cabozantinib s-malate is marketed as Cabometyx and Cometriq. It is primarily approved for:

• Hepatocellular carcinoma (HCC)
• Medullary thyroid cancer (MTC)
• Renal cell carcinoma (RCC)

Additionally, pivotal trials are ongoing for prostate cancer and other solid tumors. The global oncology drug market exceeds $222 billion in 2022, with targeted therapies representing 38% of that figure (IQVIA, 2022). The demand for tyrosine kinase inhibitors (TKIs) targets an expanding, multi-billion dollar segment.

Revenue and Sales Forecasts

Revenue Base

• 2019: Revenue of $535 million
• 2020: Revenue increased to $633 million
• 2021: Revenue grew defensively to $754 million
• Projected 2025 sales are forecasted at $1.3 billion (EvaluatePharma, 2022).

Drivers

• Increased adoption in HCC (post-approval of second-line treatment)
• Label expansion into RCC and other indications
• Growing prevalence of target patient populations

Competitive Position

Cabozantinib’s main competitors include sorafenib, lenvatinib, and newer TKIs like tivozanib. Its efficacy profile and side effect management influence its market share.

Pipeline and Development Progress

Ongoing Indications

• Prostate Cancer: Phase III trials for metastatic castration-resistant prostate cancer (mCRPC)
• Additional Solid Tumors: Trials underway for pancreatic, gastric, and other cancers.

Pipeline Potential

A promising combination with immunotherapies, such as immune checkpoint inhibitors, can expand indications. Evidence from early-phase trials supports ongoing research collaborations with pharma giants.

Regulatory Milestones

• FDA approval: 2016 for MTC and RCC
• EMA approval: 2016 for RCC
• Pending data could lead to expanded labels, influencing revenue prospects.

Cost Structure and Margins

Gross margins for cabozantinib tend to average 70-75% due to high drug pricing and manufacturing efficiencies. Costs for R&D contribute approximately 15% of revenue, reflecting a mature commercial footprint. Patent expirations around 2029-2030 pose future generic competition risks.

Competitive Threats and Market Challenges

• Generic Entry: Patent expiry could erode margins and reduce revenues post-2030.
• Pipeline Failures: Unsuccessful trials could limit future growth.
• Pricing Pressure: Healthcare systems' reimbursement constraints may cap prices.

Investment Risks

• Clinical trial setbacks
• Regulatory delays or rejections
• Competitive advancements reducing market share
• Patent expiration timelines

Valuation Context

Current market capitalization approximates $8 billion (as of Q1 2023). Applying a forward Price/Sales ratio between 15-20 yields implied revenues of $400 million – $533 million. Growth projections align with a potential revenue milestone of near $1.3 billion by 2025, which supports a high multiple but exposes the valuation to execution risks.

Key Takeaways

• Cabozantinib s-malate remains a significant player in targeted oncology treatments, with strong current sales and multiple growth avenues.
• Its pipeline offers potential for future expansion but includes clinical and regulatory risks.
• Patent expiry around 2029-2030 could challenge long-term profitability unless new indications or formulations are developed.
• Competitive dynamics and reimbursement policies influence future market share and margins.

Frequently Asked Questions

1. What are the primary drivers of cabozantinib’s revenue growth?
Increased uptake for approved indications, label expansions, and emerging uses in previously untested tumors.

2. How does patent expiry impact long-term valuation?
Patent expiry around 2029-2030 may lead to generic competition, possibly halving revenues unless new patents or formulations extend exclusivity.

3. What are the main risks associated with investing in cabozantinib?
Clinical trial failures, regulatory setbacks, emerging competitors, and reimbursement constraints.

4. How competitive is cabozantinib compared to other TKIs?
It offers comparable efficacy in some indications but differentiation depends on side effect profiles and combination therapy potential.

5. What future developments could influence cabozantinib’s valuation?
New indications, successful Phase III trial results, strategic collaborations, and patent protections.

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References

[1] IQVIA. (2022). 2022 Global Oncology Market Report.
[2] EvaluatePharma. (2022). World Preview: 2022 Outlook.
[3] U.S. Food and Drug Administration. (2016). Cabozantinib Approval Documents.