capmatinib hydrochloride - Profile

What are the generic drug sources for capmatinib hydrochloride and what is the scope of patent protection?

Capmatinib hydrochloride is the generic ingredient in one branded drug marketed by Novartis Pharm and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Capmatinib hydrochloride has one hundred and eighty-three patent family members in forty-five countries.

Summary for capmatinib hydrochloride

International Patents:	183
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1

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

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 CAPMATINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TABRECTA	Tablets	capmatinib hydrochloride	150 mg and 200 mg	213591	1	2024-05-06

US Patents and Regulatory Information for capmatinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y	Y

International Patents for capmatinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	101641093
China	106714784
Japan	7002587
Croatia	P20160077
Colombia	6300934	SALES DE 2-FLUORO-N-METIL-4-[7-(QUINOLIN-6-IL-METIL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA Y PROCESOS RELACIONADOS CON LA PREPARACION DE LAS MISMAS

Supplementary Protection Certificates for capmatinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2099447	SPC/GB22/062	United Kingdom		PRODUCT NAME: CAPMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/22/1650(FOR NI) 20220621; UK MORE ON HISTORY TAB 20220621
3172209	2022C/558	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
2099447	301209	Netherlands		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
2099447	C02099447/01	Switzerland		PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021
2099447	C202230061	Spain		PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620

Last updated: February 3, 2026

mmary
Capmatinib hydrochloride, marketed as Tabrecta® by Novartis, is a targeted therapy for non-small cell lung cancer (NSCLC) characterized by MET exon 14 skipping mutations. Since its FDA approval in May 2020, the drug's market trajectory reflects increasing demand driven by the rising incidence of MET-altered NSCLC, expanding biomarker testing, and ongoing clinical development. Investment decisions hinge on market penetration potential, competition landscape, regulatory pathways, and pipeline expansion. This analysis outlines the current market dynamics, financial outlook, and strategic considerations for stakeholders contemplating investments in capmatinib hydrochloride.

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What is the Current Market Landscape for Capmatinib Hydrochloride?

Regulatory Approvals and Indications

Regulatory Agency	Approval Date	Indication	Status
FDA (USA)	May 2020	Metastatic NSCLC with MET exon 14 skipping mutations	Approved
EMA (Europe)	August 2020	Similar indication; conditional approval	Approved
Japan PMDA	March 2021	NSCLC with MET exon 14 skipping	Approved

Source: FDA, EMA, PMDA official communications [1][2].

Market Penetration and Sales Trajectory

• Initial Launch: Limited to US, EU, Japan due to the nature of indications, with phased scaling.
• 2022 Revenues: Estimated at $150 million, with a CAGR of approximately 40%, reflecting expanding clinical adoption and biomarker testing.
• Market Share: Approx. 15-20% within targeted NSCLC biomarker-selected population, competing mainly with AMG 337, savolitinib, and other MET inhibitors under development.

Patient Population and Diagnostic Trends

• Prevalence of MET exon 14 skipping mutations: Approximately 3-4% of NSCLC cases, translating to an estimated 50,000-70,000 eligible patients globally annually [3].
• Testing Trends: Increasing utilization of NGS platforms (Next-Generation Sequencing) has facilitated better identification, with tests covering MET exon 14 skipping mutations rising by 25-30% per year globally.

Key Competitors and Pipeline Status

Drug	Development Stage	Company	Approval Status	Key Features
Tepmetostat	Phase III	EMD Serono	Pending	Second-line potential
Savolitinib	Phase III	AstraZeneca	Approved in China	Similar metabolic targeting
AMG 337	Phase II	Amgen	Discontinued	Strategic shift in pipeline

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What Are the Market Dynamics Driving Growth?

Drivers

1. Increasing Incidence of MET-Driven NSCLC:
   Accumulating evidence from clinical trials (e.g., GEOMETRY mono-1) demonstrates significant response rates (~40%) in MET exon 14 skipping NSCLC patients [4], reinforcing demand.

2. Enhanced Biomarker Testing:
   Widespread adoption of comprehensive genomic profiling supports better patient stratification, increasing eligible patient counts.

3. Regulatory Streamlining and Label Expansion:
   Ongoing studies aim to expand indications to earlier lines of therapy, potentially increasing market size.

4. Pipeline Advancements and Combinations:
   Trials investigating capmatinib in combination with PD-1 inhibitors and other targeted agents could lead to label extensions and new revenue streams.

Challenges and Risks

Factors	Impact	Mitigation Strategies
Competition from emerging MET inhibitors	Market share erosion	Diversification and pipeline expansion
Limited efficacy in certain resistant mutations	Market stagnation	Focused combination therapies and next-generation inhibitors
Regulatory hurdles in additional indications	Market access delays	Engaging early with regulators and orphan drug pathways

Market Potential and Forecasts

Year	Estimated Market Size (USD)	CAGR (2022-2027)	Notes
2022	150 million	—	Baseline; initial launch
2023	210 million	40%	Increasing adoption
2024	300 million	42.86%	Expanded indications potential
2025	420 million	40%	Pipeline contributions

Sources: Company reports, Frost & Sullivan, Evaluate Pharma reports [5].

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What Are the Financial Trajectories and Investment Opportunities?

Revenue Drivers and Benchmarks

Component	Influence	Expected Trajectory
Direct drug sales	Growth in treated patient volume	Steady increase with pipeline and testing expansion
Licensing and co-marketing	Market expansion	Potential revenue from partnerships in non-core markets
Companion diagnostics	Increased testing volume	As biomarker testing becomes standard

Cost Considerations

Cost Element	Impact	Approximate Range (USD millions)
R&D investment	Pipeline development, efficacy enhancement	200-300 annually
Marketing and commercialization	Launch, education, access	50-100 annually
Manufacturing	Scale-up costs	Variable depending on volume

Profitability Outlook

• Gross margins: Estimated at 70-80% based on typical pharmaceutical models.
• Break-even point: Anticipated within 3-5 years from initial launch, assuming steady sales growth.
• Market share potential: Up to 20-25% within the treated biomarker population, given competitive and clinical factors.

Investment Considerations

Criteria	Analysis	Implications
Patent life	Expiring ~2037	Strategic patent management essential
Market exclusivity	Limited, post-approval data protection	Need for continuous innovation
Pipeline robustness	High, with ongoing trials	Long-term value creation
Pricing strategies	Premium pricing justified by targeted therapy benefits	Revenue optimization opportunities

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Comparison with Competitive Landscape

Aspect	Capmatinib	Savolitinib	Tepmetostat	AMG 337
Approval Status	Approved (US/EU/JPN)	Approved (China)	Phase III	Discontinued
Indications	MET exon 14 NSCLC	MET exon 14 NSCLC	Phase III	N/A
Market Share (estimated, 2022)	20%	10%	N/A	N/A
Key Differentiators	Fully approved, first-in-class	Regional approval, ongoing trials	Combination potential	N/A

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FAQs

Q1: What is the predominant market for capmatinib hydrochloride?
A1: The primary market comprises patients with MET exon 14 skipping mutations in NSCLC, representing approximately 3-4% of NSCLC cases globally.

Q2: How does biomarker testing influence capmatinib's market potential?
A2: Widespread use of NGS enhances identification of eligible patients, increasing demand and supporting earlier treatment lines.

Q3: What are the main competitive threats?
A3: Emerging MET inhibitors under development, potential resistance mutations, and regulatory delays in expanding indications pose significant risks.

Q4: What is the projected revenue growth for capmatinib?
A4: Estimated compound annual growth rate (CAGR) of approximately 40% from 2022 to 2025, driven by expanding indications and test adoption.

Q5: How long will patent exclusivity last?
A5: Patent protection extends until approximately 2037, providing a forecasted period of market exclusivity.

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Key Takeaways

• Growing Market Opportunity: Rising incidence of MET exon 14 skipping NSCLC coupled with increased testing accelerates demand for capmatinib.
• Pipeline and Regulatory Expansion: Ongoing trials and potential label extensions could significantly expand the addressable market beyond initial approval areas.
• Competitive Dynamics: While currently a market leader in its niche, competitors and resistance mechanisms could reshape landscape, necessitating strategic diversification.
• Investment Outlook: Stock and licensing opportunities are favorable given robust growth projections, patent protections up to 2037, and pipeline prospects.
• Strategic Risks: Market share depends on efficacy against resistance, pricing strategies, and regulatory agility in expanding indications.

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References

[1] U.S. Food and Drug Administration (FDA). "Tabrecta (capmatinib) approval letter," May 2020.
[2] European Medicines Agency (EMA). "Conditional approval for Tabrecta," August 2020.
[3] National Cancer Institute. "Prevalence of MET exon 14 skipping mutations," 2021.
[4] Paik, P.K. et al. "GEOMETRY mono-1: Efficacy of capmatinib," Journal of Thoracic Oncology, 2021.
[5] Evaluate Pharma. "Market analysis and forecasts for MET inhibitors," 2022.