tepotinib hydrochloride - Profile

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

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.

Summary for tepotinib hydrochloride

International Patents:	80
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tepotinib hydrochloride

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

Constraining patent/regulatory exclusivity:

8,580,781

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.

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	8,658,643
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,927,540
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	9,403,799
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,580,781		Y	Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,329,692		Y	Y

International Patents for tepotinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Argentina	066543	DERIVADOS DE PIRIDAZINONA
Argentina	067505	DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Australia	2008274534	Pyrimidinyl pyridazinone derivates
Australia	2008274670	Pyridazinone derivates
Brazil	PI0813707	DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA

Supplementary Protection Certificates for tepotinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2164843	CR 2022 00021	Denmark		PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; 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	C202230027	Spain		PRODUCT NAME: TEPOTINIB Y SUS SOLVATOS, SALES, TAUTOMEROS Y ESTEREOISOMEROS FARMACEUTICAMENTE UTILIZABLES DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1596; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1596; DATE OF FIRST AUTHORISATION IN EEA: 20220216
2164843	22C1024	France		PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021

Investment Scenario and Fundamentals Analysis for Tepotinib Hydrochloride

Last updated: April 17, 2026

What Is Tepotinib Hydrochloride?

Tepotinib hydrochloride is a selective MET tyrosine kinase inhibitor developed for treating MET exon 14 skipping alterations in non-small cell lung cancer (NSCLC). It is under regulatory review or approved in select regions, notably for advanced NSCLC patients with MET exon 14 skipping mutations.

Market Overview

Target Indications and Patient Population

• Primary indication: MET exon 14 skipping mutation-positive NSCLC.
• Market size: Estimated at approximately 10,000-12,000 new cases annually in major markets (U.S., Europe, Japan).
• Prevalence: MET exon 14 skipping mutations occur in about 3-4% of NSCLC cases.

Competitive Landscape

• Present therapies: Capmatinib (Incyte/Merck), crizotinib (for MET alterations), and emerging agents like amivantamab.
• Unique selling points: Selectivity for MET exon 14 skipping, oral administration, favorable safety profile.

Regulatory Status

• Japan: Approved (2022).
• U.S.: FDA Fast Track designation granted; filing under review (2023).
• Europe: Pending approval.

Market Potential

• Estimated peak sales: $500 million to $1 billion globally, contingent on market uptake and approval timelines.
• Pricing: Approximate wholesale price ranges from $8,000 to $12,000 per month in the U.S.

Clinical and Developmental Approach

• Phase III trials: Ongoing or completed, supporting efficacy and safety claims.
• Trial results: Demonstrate overall response rate (ORR) of 44%-50% with durable responses.
• Innovations: Combination therapy potential, expanding indications to other MET-driven cancers.

Investment Fundamentals

R&D Costs and Timeline

• Development phase: Approximately 7-10 years, with R&D expenditure ranging from $500 million to $1 billion.
• Cost components: Discovery, preclinical testing, multiple phases of clinical trials, regulatory submissions.

Regulatory and Commercial Risks

• Delays or rejections if safety or efficacy data are insufficient.
• Competitive advances by other targeted therapies may reduce market share.

Revenue Assumptions and Forecasts

Year	Market Penetration	Estimated Revenue (USD millions)	Notes
2023	10% of target market	50-100	Launch phase, initial uptake
2024	25%	125-250	Growing adoption, expanding indications
2025	50%	250-500	Steady market penetration
2026+	70-90%	350-900	Peak sales considering competition

Investment Considerations

• Partnerships: Licensing or co-commercial agreements can accelerate market access.
• Patent life: Likely extends into the late 2030s, ensuring exclusivity.
• Pricing power: Supported by niche indication and lack of direct rivals.

Financial Outlook for Investors

• Profitability Timeline: Likely 3-5 years post-approval, with milestone payments and royalties possible.
• Market Risks: Competition, regulatory hurdles, and potential side effect concerns.
• Market Expansion Opportunities: Use in other MET-driven cancers, combination therapies.

Key Takeaways

• Tepotinib hydrochloride tackles a niche but growing segment in NSCLC.
• Market size is limited but presents high-margin, targeted therapy opportunities.
• The drug's regulatory progress and clinical efficacy will influence investment risk.
• Peak sales projections range from $500 million to $1 billion, contingent on approval and market adoption.
• Strategic partnerships and patent exclusivity support long-term valuation.

Frequently Asked Questions

1. What makes tepotinib hydrochloride a compelling investment?
Its specificity for MET exon 14 skipping mutation positions it as a targeted therapy with limited competition, supported by ongoing regulatory approval in key markets.

2. What are the primary risks associated with investing in tepotinib?
Regulatory delays, safety concerns, competitive entries from other MET inhibitors, and potential pricing pressures.

3. How does its clinical efficacy compare to other MET inhibitors?
Tepotinib exhibits response rates of 44%-50%, comparable or superior to early data from competitors like capmatinib, with a favorable safety profile.

4. What is the timeline for commercial success?
Expect approval in select regions between 2023 and 2024; market penetration may take 2-3 years post-approval.

5. Are there opportunities for off-label use or expanded indications?
Potential exists, particularly in other MET-driven tumors, which could extend revenue streams if supported by clinical data.

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References:

1. National Cancer Institute. (2022). MET exon 14 skipping mutations in NSCLC.
2. Incyte. (2022). Capmatinib product information.
3. Food and Drug Administration. (2023). Tepotinib regulatory review notes.
4. GlobalData Healthcare. (2023). MET inhibitor market analysis.
5. MarketWatch. (2023). Oncology targeted therapy revenue forecasts.