CAPMATINIB HYDROCHLORIDE - Generic Drug Details

What are the generic 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-three patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for CAPMATINIB HYDROCHLORIDE

International Patents:	183
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

Constraining patent/regulatory exclusivity:

10,596,178

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
Cancer Research UK	PHASE2
Royal Marsden NHS Foundation Trust	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

L01EP	Cellular-mesenchymal-epithelial transition factor (c-MET) kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	12,084,449
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,420,645		Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	12,084,449
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	8,901,123
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	10,596,178		Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	7,767,675		Y	Y

International Patents for CAPMATINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Argentina	111428
Philippines	12017500121	TABLET FORMULATION OF A C-MET INHIBITOR
World Intellectual Property Organization (WIPO)	2008064157
Spain	2857523
Croatia	P20181622
Brazil	PI0719333
Croatia	P20171528

Supplementary Protection Certificates for CAPMATINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	SPC/GB22/061	United Kingdom		PRODUCT NAME: CAPMATINIB DIHYDROCHLORIDE SALT; REGISTERED: UK EU/1/22/1650(FOR NI) 20220621; UK MORE ON HISTORY TAB 20220621
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
3172209	122022000076	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447	C02099447/01	Switzerland		PRODUCT NAME: CAPMATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67648 26.04.2021
3172209	51/2022	Austria		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
2099447	122022000083	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447	2022C/557	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621

Market Dynamics and Financial Trajectory for Capmatinib Hydrochloride

Last updated: February 13, 2026

Capmatinib hydrochloride, marketed as Mayzent, is a kinase inhibitor FDA-approved for treatment of specific non-small cell lung cancer (NSCLC) cases with MET exon 14 skipping mutations. It is developed by Incyte Corporation and Novartis. The drug's market trajectory is shaped by clinical efficacy, regulatory status, competitive landscape, and broader healthcare trends.

Regulatory Status and Adoption

Capmatinib received FDA approval on May 6, 2020, for metastatic NSCLC with MET exon 14 skipping mutations in adult patients. Subsequently, it gained approval across multiple markets, including the European Union, Canada, and Japan. The approval was supported by results from the GEOMETRY mono-1 trial, demonstrating an overall response rate (ORR) of 41% in previously treated patients and 68% in treatment-naïve patients[1].

Market penetration depends on the identification of MET exon 14 skipping mutations, estimated to occur in 3-4% of NSCLC cases. Diagnostic testing for this mutation influences the drug's utilization and adoption rate.

Market Size and Forecast

The global NSCLC segment was valued at approximately $13 billion in 2022 and is expected to grow at a CAGR of 4% through 2030. Capmatinib targets an estimated 8,000-10,000 eligible patients annually worldwide, considering geographic disparities in mutation prevalence[2].

The drug's niche positioning within targeted therapies limits initial volume but offers high pricing power. Incyte and Novartis price capmatinib at approximately $17,000 per month, aligning with the price for similar targeted agents and reflecting value from mutation-specific efficacy.

Competitive Landscape

• Other MET inhibitors: Tepotinib (Erlota by Merck), approvals for MET exon 14 skipping NSCLC, present a direct competitor. The choice between the two relies on diagnostic accuracy, side effect profile, and clinical efficacy.
• Broader targeted therapies: Drugs like osimertinib for EGFR mutations or pembrolizumab for PD-L1 expression occupy adjacent markets, potentially influencing overall NSCLC treatment algorithms.
• Emerging agents: KRAS and other mutation inhibitors expanding the treatment landscape could impact demand for capmatinib over time.

Market Challenges

• Diagnostic dependencies: Accurate and timely detection of MET exon 14 skipping mutations remains critical for patient selection. Limited access or reimbursement issues can constrain market penetration.
• Pricing and reimbursement: High drug costs necessitate negotiations with payers and may limit access in some markets.
• Resistance development: Emergence of resistance mechanisms may diminish long-term efficacy, prompting combination therapy development.

Financial Outlook

Incyte’s revenue from capmatinib was approximately $50 million in 2021, with growth primarily driven by expansions in approved indications and geographic markets[3]. Novartis’s contribution is less transparent due to joint development agreements but likely accounts for a significant portion of sales.

Projections suggest that, with increased diagnostic screening and expanded indications, global sales could reach $500 million annually by 2030. This assumes steady market share growth, successful reimbursement negotiations, and maintenance of clinical efficacy against competitors.

Future Drivers

• Broader indications: Pending approvals for frontline NSCLC and other MET-driven tumors could significantly expand the market.
• Combination therapies: Trials combining capmatinib with immune checkpoint inhibitors or chemotherapy may enhance efficacy and uptake.
• Molecular diagnostics advances: Improved detection methods, such as liquid biopsies, facilitate patient identification and increase treatment personalization.

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Key Takeaways

• Capmatinib is a targeted therapy approved for specific NSCLC cases with MET exon 14 skipping mutations.
• Its success hinges on accurate diagnostics, reimbursement strategies, and competitive positioning against agents like tepotinib.
• The drug’s global market potential could reach $500 million annually by 2030, contingent on successful clinical and regulatory milestones.
• The evolution of combination regimens and expanded indications are primary growth catalysts.
• Market challenges include diagnostic access, high pricing, and potential resistance development.

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FAQs

1. What is the primary regulatory challenge for capmatinib?
Obtaining approvals for new indications and expanding existing ones, especially in jurisdictions with limited diagnostic infrastructure, remains key.

2. How does capmatinib compare to other MET inhibitors?
Tepotinib has similar indications with comparable efficacy; choice depends on clinician familiarity, diagnostic algorithms, and side-effect profiles.

3. What are the main factors influencing its revenue growth?
Market access, diagnostic adoption, approval of additional indications, and the development of combination therapies.

4. How significant is the mutation prevalence for market size?
MET exon 14 skipping mutations occur in 3-4% of NSCLC cases, narrowing the eligible patient pool but allowing for high per-patient pricing.

5. What are future risks to growth?
Emerging resistance, competition, reimbursement hurdles, and delays in regulatory approvals for expanded uses.

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References

[1] FDA. (2020). FDA approves first targeted treatment for metastatic non-small cell lung cancer with MET exon 14 skipping mutations.
[2] GlobalData. (2022). NSCLC market forecast.
[3] Incyte Corporation. (2021). Annual Report.