Capmatinib hydrochloride - Generic Drug Details

What are the generic drug sources for capmatinib hydrochloride and what is the scope of freedom to operate?

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-two patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for capmatinib hydrochloride

International Patents:	182
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	27
DailyMed Link:	capmatinib hydrochloride at DailyMed

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.

Recent Clinical Trials for capmatinib hydrochloride

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

Sponsor	Phase
Intergroupe Francophone de Cancerologie Thoracique	PHASE3
Novartis Pharmaceuticals	PHASE2
University of Birmingham	PHASE2

See all capmatinib hydrochloride clinical trials

Pharmacology for capmatinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Mesenchymal Epithelial Transition Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for capmatinib hydrochloride

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

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			Y	Y
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	213591-002	May 6, 2020		RX	Yes	Yes			Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y

International Patents for capmatinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Mexico	2019011954
Hong Kong	1251568
Hong Kong	1175700
Portugal	2497470
Taiwan	201613595	Tablet formulation of a C-MET inhibitor
Malaysia	155565
Hong Kong	1136489

Supplementary Protection Certificates for capmatinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	CA 2022 00056	Denmark		PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
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
2099447	CA 2022 00053	Denmark		PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	122022000083	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447	301209	Netherlands		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
2099447	827	Finland

Market Dynamics and Financial Trajectory for Capmatinib Hydrochloride

Last updated: July 27, 2025

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Introduction

Capmatinib hydrochloride, marketed under the tradename Tabrecta (or magnifying its generic potential), represents a precision-targeted therapy in the realm of oncology. Specifically developed as a selective MET inhibitor, capmatinib is tailored for non-small cell lung cancer (NSCLC) patients harboring MET exon 14 skipping mutations, a subset accounting for approximately 3-4% of NSCLC cases. The drug’s market trajectory reflects a confluence of scientific innovation, regulatory milestones, and evolving oncological treatment landscapes.

This analysis delineates the current market dynamics and projects the financial trajectory of capmatinib hydrochloride, considering factors such as clinical efficacy, regulatory decisions, competitive landscape, pricing strategies, and emerging market trends.

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Pharmacological Profile and Clinical Development Landscape

Capmatinib's mechanism targets aberrant MET signaling, implicated in tumor proliferation, survival, and metastasis (1). Its clinical development trajectory includes pivotal trials—GEOMETRY mono-1—the basis for FDA approval in 2020. The drug demonstrated significant objective response rates (ORRs) in MET exon 14 skipping NSCLC patients, with a manageable safety profile.

The rarity of this mutation has historically limited market size but also underlines the importance of personalized medicine. The drug’s efficacy in a molecularly defined subset positions it as a vital component of targeted therapy regimens, bolstering its long-term clinical relevance.

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Regulatory Milestones and Global Adoption

In 2020, the United States Food and Drug Administration (FDA) granted accelerated approval for capmatinib for patients with locally advanced or metastatic NSCLC characterized by MET exon 14 skipping mutations (2). The European Medicines Agency (EMA) followed with a conditional approval, emphasizing the drug’s unmet medical need.

Subsequent approvals in Japan and other regions expand its geographic footprint, though uptake varies depending on the regional regulatory climate, healthcare system receptivity, and diagnostic infrastructure. The delayed approval timelines in emerging markets impact the geographical revenue spread.

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Market Dynamics

Targeted Niche within Oncology

Capmatinib occupies a niche in the precision oncology segment, competing against other MET inhibitors such as tepotinib (Vafseo) and savolitinib, as well as broader NSCLC targeted therapies. The differentiation hinges on efficacy, safety, biomarker testing protocols, and regulatory endorsements.

Pricing Strategy and Reimbursement

Pricing in highly specialized oncology drugs is influenced by clinical value propositions, competitiveness, and healthcare reimbursement policies. Capmatinib’s therapeutic niche often commands premium pricing, with costs ranging in the ballpark of $11,000–$15,000 per month in the U.S., based on pricing disclosures (3). Reimbursement policies and payer acceptance significantly impact market penetration, especially in price-sensitive regions.

Diagnostics and Companion Testing

Successful market penetration necessitates accurate detection of MET exon 14 skipping mutations. The availability, cost, and implementation of companion diagnostics are critical; delays or limitations in molecular testing infrastructure restrict patient eligibility, curbing sales potential.

Market Competition and Pipeline Development

The competitive landscape remains dynamic, with the emergence of next-generation MET inhibitors and combination regimens. Clinical trials exploring synergistic therapies may alter the landscape, potentially impacting capmatinib’s market share. Additionally, the expansion of indications beyond NSCLC—such as other solid tumors with MET alterations—can augment revenue streams.

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Financial Trajectory

Revenue Streams and Forecasts

Considering the drug’s initial rapid uptake in the U.S. and Europe, revenue in the first 2-3 years post-approval was estimated at approximately $200–$300 million globally (4). Factors influencing future revenue include:

• Market Penetration: Adoption rates governed by clinical practice patterns and diagnostic infrastructure.
• Expansion of Indications: Ongoing clinical trials for other tumors may broaden FDA and EMA approvals.
• Reimbursement Policies: Payer acceptance directly impacts sales volumes.
• Pricing Strategies: Premium pricing sustains revenue but invites reimbursement challenges.

Projected revenues are expected to experience moderate growth, reaching approximately $500 million annually within 5 years, contingent upon broader adoption and indication expansion.

Cost and Investment Considerations

Manufacturing costs are relatively stable due to the synthetic complexity of kinase inhibitors, though R&D expenditures for pipeline expansions and diagnostics are significant. Patent protections, expected to last until the late 2020s, afford exclusivity that sustains premium pricing.

Market Risks

Key risks include regulatory delays in other jurisdictions, competitive threats from alternative therapies, and the evolving molecular testing landscape. The emergence of resistance mechanisms limits long-term efficacy, demanding ongoing research.

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Market Outlook and Emerging Trends

The oncology market increasingly favors combination therapies. Early-phase studies suggest that capmatinib combined with other agents like immune checkpoint inhibitors could enhance efficacy, potentially opening new therapeutic avenues and revenue streams.

Digital health tools improving molecular testing accuracy and the integration of genomic data into routine practice could accelerate market access and patient identification, bolstering the financial outlook.

Regionally, the Asia-Pacific market offers substantial growth opportunities due to increasing cancer prevalence and expanding healthcare infrastructure, despite regulatory and reimbursement hurdles.

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Key Factors Influencing Future Market and Financial Performance

• Expansion of indications into other MET-driven cancers.
• Development of next-generation inhibitors with improved efficacy and safety profiles.
• Advances in companion diagnostics enabling wider patient identification.
• Strategic partnerships with diagnostic companies and healthcare providers.
• Competitive pressure from emerging therapies and biosimilars.

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Key Takeaways

• Niche Market Position: Capmatinib’s targeted approach and regulatory endorsements solidify its role in MET exon 14 skipping NSCLC, though its market size remains constrained by mutation prevalence.
• Pricing and Reimbursement Influence: Premium pricing is sustainable within high-income markets with favorable reimbursement, whereas cost barriers limit adoption elsewhere.
• Diagnostic Infrastructure as a Bottleneck: Efficient patient selection hinges on access to molecular testing; improvements here can significantly boost revenue.
• Pipeline and Indication Expansion Vital: Expanding into other tumor types with MET alterations and developing combination regimens are critical for growth.
• Competitive Landscape Evolves: Ongoing development of alternatives and resistance management strategies will shape the long-term financial trajectory.

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FAQs

1. What is the primary therapeutic target of capmatinib hydrochloride?
Capmatinib selectively inhibits the MET tyrosine kinase receptor, which is aberrantly activated in cancers with MET exon 14 skipping mutations, most notably in NSCLC.

2. How does regulatory approval impact the market for capmatinib?
Regulatory endorsements from agencies like the FDA and EMA authorize market entry and reimbursement coverage. Conditional and accelerated approvals facilitate early access but often require confirmatory trials.

3. What are the main challenges facing capmatinib's market growth?
Limited prevalence of MET exon 14 skipping mutations, dependence on molecular diagnostic infrastructure, competition from other MET inhibitors, and pricing/reimbursement policies are key challenges.

4. How might combination therapies influence capmatinib's financial prospects?
Combining capmatinib with immune checkpoint inhibitors or other targeted agents could improve efficacy, expand indications, and increase sales but also introduce complexity in clinical development and regulatory approval.

5. What regional markets offer the most significant growth potential for capmatinib?
The United States and Europe provide early adopter markets, but the Asia-Pacific region, especially China and Japan, offers substantial long-term growth opportunities due to increasing cancer incidence and expanding healthcare infrastructure.

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References

1. Vail, M. et al. (2019). "Targeted Therapeutics for MET-Driven Lung Cancer." Cancer Treatment Reviews.
2. FDA (2020). "FDA Grants Accelerated Approval to Capmatinib for Metastatic NSCLC."
3. MarketWatch (2022). "Pricing Trends for Targeted Oncology Therapies."
4. IQVIA Reports (2021). "Global Oncology Market Forecast."