TEPOTINIB HYDROCHLORIDE - Generic Drug Details

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

Tepotinib hydrochloride is the generic ingredient in one branded drug marketed by Emd Serono Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tepotinib hydrochloride has seventy-nine patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for TEPOTINIB HYDROCHLORIDE

International Patents:	79
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	25
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEPOTINIB HYDROCHLORIDE
What excipients (inactive ingredients) are in TEPOTINIB HYDROCHLORIDE?	TEPOTINIB HYDROCHLORIDE excipients list
DailyMed Link:	TEPOTINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEPOTINIB 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 TEPOTINIB HYDROCHLORIDE

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

Sponsor	Phase
Intergroupe Francophone de Cancerologie Thoracique	PHASE3
EMD Serono	PHASE2
SWOG Cancer Research Network	PHASE2

See all TEPOTINIB HYDROCHLORIDE clinical trials

Pharmacology for TEPOTINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Mesenchymal Epithelial Transition Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TEPOTINIB HYDROCHLORIDE

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

US Patents and Regulatory Information for TEPOTINIB HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes			Y	Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes			Y	Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes			Y

International Patents for TEPOTINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Croatia	P20150031
Malaysia	153727	PYRIDAZINONE DERIVATIVES
South Korea	101553418
Lithuania	PA2022009
France	22C1024
Denmark	2754660
Cyprus	1115925

Supplementary Protection Certificates for TEPOTINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2164843	CA 2022 00021	Denmark		PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217
2164843	301176	Netherlands		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843	22C1024	France		PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843	PA2022009	Lithuania		PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843	2290029-4	Sweden		PRODUCT NAME: TEPOTINIB AND PHARMACEUTICALLY USABLE SOLVATES, SALTS, AND TAUTOMERS THEROF; REG. NO/DATE: EU/1/21/1596 20220217
2164843	PA2022009,C2164843	Lithuania		PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021

Market Dynamics and Financial Trajectory for Tepotinib Hydrochloride

Last updated: July 28, 2025

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Introduction

Tepotinib hydrochloride, marketed as Tepmetko, is an oral, selective MET inhibitor developed by Merck KGaA and Merck Sharp & Dohme (MSD). Originally approved by the U.S. Food and Drug Administration (FDA) in February 2020 for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, it exemplifies targeted oncology therapy with tailored molecular precision. As the landscape of targeted cancer treatments accelerates, understanding the evolving market dynamics and financial trajectory of tepotinib hydrochloride offers critical insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Landscape and Drivers

1. Growing Incidence of MET Exon 14 Skipping Mutations in NSCLC

The primary indication for tepotinib hydrochloride is NSCLC with MET exon 14 skipping alterations. Studies estimate this mutation occurs in approximately 3-4% of NSCLC cases, which translates to an estimated 15,000–20,000 potential patients annually in the U.S. alone [1]. Globally, as NSCLC accounts for approximately 85% of lung cancers, the market is sizable, especially considering the increasing rates of molecular testing and precision medicine integration.

2. Increasing Adoption of Molecular Diagnostics

Advancements in next-generation sequencing (NGS) have improved detection rates of MET exon 14 skipping mutations, thus expanding candidate eligibility. Enhanced diagnostic infrastructure, coupled with regulatory endorsements like FDA approval and the FDA-approved companion diagnostic—FoundationOne CDx—create favorable conditions for market expansion. An increase in testing rates correlates with anticipated concomitant growth in tepotinib sales.

3. Competitive Positioning and Therapeutic Landscape

Tepotinib faces competition primarily from other MET inhibitors such as Capmatinib (Tabrecta) and Savolitinib, as well as broader pipeline agents. The approval of Capmatinib in 2020 for similar indications and ongoing clinical trials for combination therapies influence market share. The differentiation of tepotinib’s safety profile, efficacy, and particular patient subgroup benefits will determine its competitive edge.

4. Expansion into Broader Oncology Indications

Beyond NSCLC, early-phase studies explore tepotinib’s efficacy in other MET-driven tumors, including gastric, colorectal, and liver cancers. Although these indications remain exploratory, positive data could unlock additional revenue streams, affecting the drug’s long-term financial outlook.

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Market Challenges

1. Diagnostic and Treatment Accessibility

Despite advancements, the high costs associated with molecular diagnostics and targeted therapies pose barriers in low- and middle-income countries (LMICs). Limited access reduces potential market penetration and hampers global revenue growth.

2. Resistance Development

Emergence of secondary mutations leading to resistance diminishes long-term treatment effectiveness. Managing resistance through combinatorial approaches or next-generation inhibitors remains a critical landscape challenge, impacting sales forecasts.

3. Competitive and Regulatory Risks

Patent expirations, evolving regulatory landscapes, and competitive entry during clinical development phases influence future market dynamics. The success of competitors’ pipeline products and the pace of regulatory approvals will shape tepotinib’s market trajectory.

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Financial Trajectory and Sales Forecasts

1. Initial Launch and Peak Sales

In its initial years post-approval (2020–2023), tepotinib achieved moderate uptake driven by physician familiarity, diagnostic integration, and reimbursement policies. Commercialization strategies, including partnerships with diagnostic providers, facilitated early sales. Industry estimates project peak sales between $250 million and $400 million globally within 5–7 years post-launch, contingent on market penetration and expanded indications [2].

2. Revenue Growth Drivers

• Regulatory Approvals in Additional Markets: European Union approval in 2021 expanded access, with subsequent approvals in Asian countries likely to bolster sales.
• Diagnostic-Linked Reimbursement Policies: Reimbursement coverage enhances patient access, directly influencing revenue.
• Clinical Data Accumulation: Real-world evidence demonstrating efficacy and safety diversifies usage and physician adoption.

3. Long-term Outlook

Sales are expected to plateau once the market matures and competition stabilizes. However, incremental growth may arise from combination therapies and new indications, especially if further clinical trials confirm broader efficacy.

4. Profitability Considerations

Research and development investment in ongoing trials could compress profit margins temporarily. Nonetheless, as the market matures, economies of scale and increased prescribing volumes will support profitability. The drug’s pricing, typically aligned with targeted oncology agents ($10,000–$15,000 per month), influences overall revenue, with price adjustments driven by market competition and regulatory factors.

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Market Entry and Expansion Strategies

Successful market penetration hinges on strategic initiatives:

• Robust Diagnostic Collaborations: Partnering with NGS providers ensures streamlined detection of MET exon 14 skipping mutations.
• Orphan Drug and Fast-Track Designations: These designations can accelerate approval processes in additional jurisdictions.
• Combination Therapy Development: Synergies with immune checkpoint inhibitors or other targeted agents can unlock new patient segments.
• Global Market Expansion: Entering emerging markets where lung cancer incidence is rising allows for early adoption, supported by tailored reimbursement strategies.

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Regulatory and Patent Considerations

The expiration of primary patents in key markets within the next 8–10 years will influence generics entry, impacting revenue. Developing next-generation formulations or novel combinations can extend the patent life cycle, maintaining competitive differentiation and revenue streams.

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Conclusion

Tepotinib hydrochloride represents a significant advancement in personalized NSCLC treatment, with a promising but competitive market landscape. Through strategic diagnostic partnerships, continuous clinical trial investments, and expansion into new indications and geographies, tepotinib’s financial trajectory can align with forecasted peak revenues within the next 5–7 years. However, ongoing challenges such as resistance, competitive pressures, and access barriers necessitate vigilant strategic planning to sustain growth.

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Key Takeaways

• The global market for tepotinib is driven by increasing molecular testing, rising NSCLC incidence, and expanding indications.
• Competitive landscape and resistance development pose significant challenges requiring ongoing innovation.
• Revenue forecasts project peak sales of $250–$400 million globally, contingent on broader adoption and regulatory approvals.
• Strategic collaborations with diagnostics, clinical development of combination therapies, and geographic expansion are critical for market growth.
• Patent expiries within the next decade highlight the need for innovation to extend product lifecycle and revenue streams.

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FAQs

1. What is the primary indication for tepotinib hydrochloride?
Tepotinib is primarily approved for treating metastatic NSCLC patients harboring MET exon 14 skipping mutations.

2. How does diagnostic testing influence tepotinib’s market success?
Accurate and widespread molecular diagnostics enable identification of eligible patients, directly impacting prescribing rates and sales growth.

3. What are the main competitors to tepotinib in the MET inhibitor space?
Capmatinib is the leading competitor, with others like Savolitinib and emerging pipeline agents vying for market share.

4. What factors could impact the long-term profitability of tepotinib?
Patent expirations, resistance emergence, payer reimbursement policies, and pipeline competition are key factors.

5. How might the global market for tepotinib evolve in the next decade?
Market expansion into new regions, additional indications, and combination therapies are expected to drive sustained growth, provided regulatory and access challenges are managed.

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Sources
[1] American Cancer Society. Lung Cancer Facts & Figures. 2022.
[2] EvaluatePharma. Oncology Market Forecast. 2023.