CABOZANTINIB S-MALATE - Generic Drug Details

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-seven patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for CABOZANTINIB S-MALATE

International Patents:	237
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABOZANTINIB S-MALATE
DailyMed Link:	CABOZANTINIB S-MALATE at DailyMed

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.

Recent Clinical Trials for CABOZANTINIB S-MALATE

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

Sponsor	Phase
Emory University	Phase 2
Children's Oncology Group	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3

See all CABOZANTINIB S-MALATE clinical trials

Pharmacology for CABOZANTINIB S-MALATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CABOZANTINIB S-MALATE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-002	Nov 29, 2012		RX	Yes	Yes			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No				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	208692-003	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016

International Patents for CABOZANTINIB S-MALATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4014971	COMPOSITIONS PHARMACEUTIQUES MODULATRICES DE C-MET (C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
Eurasian Patent Organization	201391145	СПОСОБЫ ПОЛУЧЕНИЯ ХИНОЛИНОВЫХ СОЕДИНЕНИЙ И ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ, СОДЕРЖАЩИХ ТАКИЕ СОЕДИНЕНИЯ
Australia	2020203645	C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS
Denmark	2387563
South Korea	20180105259

Supplementary Protection Certificates for CABOZANTINIB S-MALATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	220 50007-2014	Slovakia		PRODUCT NAME: CABOZANTINIB; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140326
2213661	CR 2014 00039	Denmark		PRODUCT NAME: CABOZANTINIB, INKLUSIVE FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER CABOZANTINIB (S)-MALAT; REG. NO/DATE: EU/1/13/890/001-003 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
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	PA2014033,C2213661	Lithuania		PRODUCT NAME: KABOZANTINIBAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/13/890/001 - EU/1/13/890/003 20140321

Market Dynamics and Financial Trajectory for CABOZANTINIB S-MALATE

Last updated: September 25, 2025

Introduction

CaboZantinib S-Malate stands as a promising therapeutic agent within the oncology domain, primarily targeting malignancies equipped in pathway inhibition strategies. As a novel kinase inhibitor, the drug’s emergence coincides with expanding interest in precision medicine. This analysis explores the evolving market landscape, competitive positioning, regulatory pathways, and financial outlook for CaboZantinib S-Malate, to aid stakeholders in strategic decision-making.

Pharmacological Profile and Clinical Development

CaboZantinib S-Malate functions as a potent, selective inhibitor of specific receptor tyrosine kinases implicated in tumor proliferation. Its mechanism underpins efficacy in solid tumors, notably non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). It is progressing through late-phase clinical trials, with data indicating acceptable safety profiles and preliminary signs of efficacy.

The clinical pipeline's robustness is critical; ongoing Phase III trials and positive interim outcomes could propel regulatory approvals. Conversely, delays or adverse trial results may impact market entry timelines and commercial prospects.

Regulatory and Approval Environment

The pathway to market hinges substantially on regulatory agency decisions, notably the U.S. FDA and European Medicines Agency (EMA). Fast-track or breakthrough therapy designations could expedite approval, especially given unmet medical needs in oncology.

As of Q1 2023, CaboZantinib S-Malate has secured Orphan Drug Designation for specific indications, offering market exclusivity benefits. However, regulatory hurdles remain, including comprehensive safety, efficacy, and manufacturing standards assessments.

Market Drivers

Growing Incidence of Targeted Cancers

The rising incidence rates of NSCLC and RCC bolster the potential demand for CaboZantinib S-Malate. According to GLOBOCAN 2020 data, lung cancer accounts for approximately 1.8 million deaths annually, underscoring the urgent need for effective, targeted therapies [1].

Advances in Precision Oncology

Enhanced understanding of tumor genetics has driven demand for kinase inhibitors. CaboZantinib S-Malate's targeted approach aligns well with this paradigm shift, increasing its market appeal amid the move away from broad-spectrum chemotherapies.

Regulatory Incentives and Pricing Policies

Incentives such as orphan drug status and favorable pricing policies in certain jurisdictions could improve commercial viability, encouraging investments in development and market penetration.

Market Challenges

Competitive Landscape

CaboZantinib S-Malate faces competition from established agents like Sunitinib, Pazopanib, and newer entrants including Lenvatinib. These drugs have marketed approvals, extensive clinical data, and established market shares.

Emerging competitors with improved efficacy and safety profiles threaten CaboZantinib S-Malate's market share. Strategic differentiation hinges on superior clinical outcomes and tailored patient stratification.

Cost and Reimbursement Dynamics

High development costs for targeted oncology drugs, coupled with complex reimbursement landscapes, may impede market access. Payers demand high-value evidence; thus, solid cost-effectiveness data will be critical.

Intellectual Property and Patent Protection

Patent life and exclusivity periods directly influence long-term revenue potential. Generic or biosimilar entrants could erode market share post-patent expiry, emphasizing timely commercialization strategies.

Financial Trajectory and Revenue Projections

Investment and Development Costs

CaboZantinib S-Malate’s late-stage development entails substantial R&D expenditures, estimated at hundreds of millions USD, considering clinical trials, manufacturing scale-up, and regulatory submissions.

Market Penetration Scenarios

Based on current data, initial adoption is likely modest, limited by existing competition. However, with positive trial outcomes and regulatory approval, revenue streams could grow exponentially.

Pricing Strategy

Targeted oncology drugs often command premium pricing; estimates suggest annual therapy costs exceeding $100,000. Price-setting will depend on comparative efficacy, safety profile, and competitive positioning.

Forecasts

In a best-case scenario, CaboZantinib S-Malate could generate revenues exceeding $1 billion globally within 5 years post-launch, assuming rapid uptake in multiple indications and successful market expansion. Conversely, delays or failure to demonstrate significant clinical benefits could restrict revenues to low hundreds of millions or less.

Market Opportunities

• Expansion into Additional Indications: Exploring efficacy in other tumor types (e.g., hepatocellular carcinoma) can diversify revenue streams.
• Combination Therapies: Synergistic use with immunotherapies may improve outcomes, opening new markets.
• Geographic Expansion: Entering emerging markets with growing oncology treatment demands could bolster revenues.

Risks and Uncertainties

Market success remains contingent upon positive clinical data, regulatory approvals, competitive landscape shifts, and reimbursement policies. Unforeseen adverse events or inferior efficacy relative to existing therapies could impair financial prospects.

Conclusion

CaboZantinib S-Malate's market dynamics are shaped by the evolving landscape of targeted cancer therapies, regulatory pathways, and competitive forces. If clinical outcomes align favorably, and regulatory hurdles are overcome, the drug could attain substantial commercial success, with revenues scaling up significantly over the next decade. However, prudent strategic planning and vigilant market monitoring are essential to navigate inherent uncertainties.

Key Takeaways

• Clinical validation remains crucial, with ongoing trials determining future approval and market penetration.
• Competitive differentiation via efficacy, safety, and patient stratification will influence market share.
• Strategic patent management and timely commercialization are vital to maximize revenue potential.
• Pricing and reimbursement negotiations significantly impact financial trajectory, especially in cost-conscious healthcare systems.
• Diversification through indications and geographic expansion can sustain growth and mitigate risks.

FAQs

1. What distinguishes CaboZantinib S-Malate from other kinase inhibitors?
CaboZantinib S-Malate’s high selectivity for specific receptor tyrosine kinases may offer improved efficacy and reduced off-target effects, potentially translating to better tolerability and sustained response in targeted populations.

2. When is CaboZantinib S-Malate expected to receive regulatory approval?
Pending positive late-phase clinical trial results, regulatory submissions are anticipated within 12–18 months, with approvals potentially granted within 6–12 months thereafter, subject to agencies' review timelines.

3. Which indications are the primary focus for initial commercialization?
Initially targeting non-small cell lung cancer and renal cell carcinoma, with subsequent exploration into other tumor types aligned with clinical trial data and regulatory designations.

4. How does competition impact CaboZantinib S-Malate's market potential?
Existing therapies with established efficacy and reimbursement deals pose significant competitive threats. Strategic differentiation and demonstrable clinical benefits are essential to secure market share.

5. What strategic opportunities exist post-approval?
Opportunities include expanding to new indications, developing combination therapies, entering emerging markets, and optimizing pricing strategies based on comparative value.

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Sources:

[1] GLOBOCAN 2020: Global Cancer Statistics. International Agency for Research on Cancer.