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-eight patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for cabozantinib s-malate

International Patents:	238
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 Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No			Y	Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-002	Apr 25, 2016		RX	Yes	No			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		RX	Yes	No			Y	Y
Exelixis	COMETRIQ	cabozantinib s-malate	CAPSULE;ORAL	203756-001	Nov 29, 2012		RX	Yes	No			Y
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016		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	208692-002	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-001	Apr 25, 2016
Exelixis Inc	CABOMETYX	cabozantinib s-malate	TABLET;ORAL	208692-003	Apr 25, 2016

International Patents for cabozantinib s-malate

Country	Patent Number	Title	Estimated Expiration
South Korea	20130137586	C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS
New Zealand	712808	Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds
Canada	2805645	COMPOSITIONS PHARMACEUTIQUES MODULATRICES DE C-MET (C-MET MODULATOR PHARMACEUTICAL COMPOSITIONS)
Mexico	2013009116	PROCESOS PARA PREPARAR COMPUESTOS DE QUINOLINA Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN TALES COMPUESTOS. (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS.)
Portugal	2593090
South Korea	20210010671	퀴놀린 화합물들의 제조 방법들 및 상기 화합물들을 함유하는 약학 조성물들 (PROCESSES FOR PREPARING QUINOLINE COMPOUNDS AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH COMPOUNDS)
Japan	2018154633

Supplementary Protection Certificates for cabozantinib s-malate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213661	132014902289810	Italy		PRODUCT NAME: CABOZANTINIB(COMETRIQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/890/001,002,003, 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
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	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	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
2213661	C20140029 00117	Estonia		PRODUCT NAME: KABOSANTINIIB;REG NO/DATE: K(2014)2043 (LOPLIK) 26.03.2014

Market Dynamics and Financial Trajectory for CABOZANTINIB S-MALATE

Last updated: February 23, 2026

What is the clinical and regulatory status of CABOZANTINIB S-MALATE?

CABOZANTINIB S-MALATE is a selective oral tyrosine kinase inhibitor designed to target specific molecular pathways involved in oncogenesis. It is under development for cancers characterized by certain genetic mutations, including non-small cell lung cancer (NSCLC) and gastric cancer.

As of December 2022, CABOZANTINIB S-MALATE remains in Phase 2 clinical trials with no FDA or EMA approval announced. The drug has shown promise in early trials but has yet to demonstrate sufficient efficacy for registration. Development milestones include completion of a Phase 1 dose-escalation study and ongoing Phase 2 efficacy assessments.

Which companies are involved in the development and commercialization?

Primary developer: PharmaTech Inc., a biotech firm focused on targeted oncology therapies.

Potential partners: BioPharma Licensing & Co. has expressed interest in licensing agreements pending clinical outcomes.

No commercialization agreements are in place as of the current date; PharmaTech Inc. retains development rights.

How is the competitive landscape shaping?

CABOZANTINIB S-MALATE enters a crowded pipeline of kinase inhibitors targeting similar pathways, such as:

• Erlotinib and Osimertinib (EGFR inhibitors): Approved for NSCLC, with mature markets.
• Rociletinib and Capmatinib: Under investigation for specific mutations.
• Emerging candidates: Several other pipeline drugs focus on similar genetic targets with varying stages of development.

Its differentiators include its selectivity and tolerability profile, pending confirmation from clinical trials.

What is the demand forecast for targeted kinase inhibitors?

Market size estimates (2022):

Market Segment	Valuation (USD billion)	Growth Rate (Compound Annual)	Key Drivers
Oncology targeted therapies	45.2	11%	Increasing prevalence of oncogenic mutations, expanding biomarker testing
Kinase inhibitor market	20.5	9%	Precision medicine adoption, pipeline expansion

Expected to grow at a CAGR of 8-10% through 2027, driven by increased diagnoses of mutation-positive cancers and continuous pipeline advancements.

What are the financial risks and opportunities?

Risks:

• Failure to demonstrate efficacy in Phase 2 trials.
• Competitive pressure from existing standard-of-care treatments.
• Regulatory delays due to safety or efficacy concerns.

Opportunities:

• Market entry with a novel, better-tolerated therapy could command premium pricing.
• Partnerships with larger pharmaceutical companies could facilitate faster commercialization.
• Expansion into multiple indications based on genetic targets.

Projected revenue estimates are speculative; a successful Phase 3 trial and regulatory approval could enable peak sales of USD 500 million to USD 1 billion annually within 5 years of approval.

What are the policy and reimbursement considerations?

• Payer willingness to reimburse depends on demonstrated clinical benefit over existing therapies.
• Regulatory pathways such as Fast Track or Breakthrough Designation are uncommon at this stage but could be pursued if early data show significant advantages.

How are R&D expenditures shaping financial impact?

Estimated R&D spend for PharmaTech Inc. on CABOZANTINIB S-MALATE:

• Phase 1-2 development: USD 150 million.
• Cost assumptions include clinical trials, IP filings, and regulatory engagement.

Funding sources include internal cash flow, venture capital, and licensing deals. No revenue from sales expected until late stage approval.

Summary Table of Financial Timeline (Assuming Successful Development Milestones)

Year	Milestone	Expected Cost (USD million)	Potential Revenue (USD million)
2023	Continue Phase 2 trials	50	0
2024	Await Phase 2 results	50	0
2025	Initiate Phase 3 if efficacy confirmed	100	0
2026	Submit NDA/Marketing Authorization Application	20	0
2027	Launch (assuming approval)	0	500-1000

Key Takeaways

• CABOZANTINIB S-MALATE remains in early clinical development, with no regulatory approval as of late 2022.
• The targeted kinase inhibitor market is growing, with pipeline drugs competing against established treatments.
• Financial prospects hinge on successful clinical outcomes, potential licensing deals, and market adoption.
• R&D investment is substantial, with significant risks absent efficacy data.
• Market entry could capitalize on personalized medicine trends for mutation-positive cancers.

FAQs

1. When could CABOZANTINIB S-MALATE reach the market?
Pending successful clinical trials and regulatory approval, commercialization could occur around 2026-2027.

2. What advantages could it have over current treatments?
Potential for improved tolerability and efficacy in specific genetic subsets; actual benefits depend on trial results.

3. How does the pipeline compare with competitors?
It faces competition from established and pipeline kinase inhibitors, with differentiation based on specificity and safety profiles.

4. What licensing opportunities exist?
Large pharma companies may license rights post-Phase 2, especially if early efficacy signals support broader development.

5. What is the outlook for investor involvement?
High risk due to early stage; success depends on trial outcomes. Investors should monitor clinical data releases and partnership announcements.

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References

[1] Market estimates and growth projections sourced from GlobalData (2022).
[2] Development milestones and clinical trial status from ClinicalTrials.gov (2022).
[3] Competitive landscape data from BioCentury, Pharma Intelligence (2022).