TEPMETKO Drug Patent Profile

Which patents cover Tepmetko, and what generic alternatives are available?

Tepmetko is a drug marketed by Emd Serono Inc and is included in one NDA. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. One supplier is listed for this compound. Additional details are available on the tepotinib hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Tepmetko

Tepmetko was eligible for patent challenges on February 3, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 19, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TEPMETKO

International Patents:	79
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	147
Drug Prices:	Drug price information for TEPMETKO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEPMETKO
What excipients (inactive ingredients) are in TEPMETKO?	TEPMETKO excipients list
DailyMed Link:	TEPMETKO at DailyMed

See drug prices for TEPMETKO

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

NDA:

214096

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.

Pharmacology for TEPMETKO

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

US Patents and Regulatory Information for TEPMETKO

TEPMETKO is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes			Y
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 TEPMETKO

When does loss-of-exclusivity occur for TEPMETKO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

France

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TEPMETKO around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	2022015
European Patent Office	2754660	Dérivés de pyridazinone (Pyridazinone derivatives)
Eurasian Patent Organization	017281	ПРОИЗВОДНЫЕ ПИРИМИДИНИЛПИРИДАЗИНОНА (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Taiwan	200906409	Pyridazinone derivatives

Supplementary Protection Certificates for TEPMETKO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
2164843	122022000047	Germany		PRODUCT NAME: TEPOTINIB SOWIE DIE PHARMAZEUTISCH VERWENDBAREN SOLVATE, SALZE UND TAUTOMERE DAVON, EINSCHL. DEREN MISCHUNGEN IN ALLEN VERHAELTNISSEN; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843	2022C/519	Belgium		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDARBE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; AUTHORISATION NUMBER AND 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

Market Dynamics and Financial Trajectory for TEPMETKO

Last updated: December 30, 2025

Summary

TEPMETKO (tepotinib) represents a novel targeted therapy addressing MET gene alterations in non-small cell lung cancer (NSCLC). Since its approval, TEPMETKO's market trajectory hinges on patent exclusivity, competitive landscape, regulatory developments, and evolving clinical data. This analysis delineates current market dynamics, forecasted financial performance, key competitors, and strategic considerations over the coming five years.

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What is TEPMETKO?

TEPMETKO (tepotinib) is an oral, selective MET inhibitor developed by Merck (MSD). It was approved by the FDA in May 2022 for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations (METex14). The drug targets a rare but actionable genomic driver, representing a precision medicine solution with distinctive market positioning.

Regulatory and Clinical Milestones

Event	Date	Details
FDA Approval	May 2022	First-in-class MET exon 14 skipping mutation therapy
EMA Submission	Q3 2022	Ongoing review for European markets
Key Clinical Trials	Phase II (VISION)	Demonstrated ORR of 46%, with durable responses
Breakthrough Therapy Designation	FDA 2021	Accelerates development and review

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What Are the Key Market Drivers for TEPMETKO?

1. Unmet Medical Need and Target Patient Population

• MET exon 14 skipping mutations occur in approximately 3-4% of NSCLC cases, translating to an estimated 30,000–40,000 patients globally annually.
• Historically, limited targeted options existed; TEPMETKO fills a critical niche.

2. Competitive Landscape

Competitors	Agents	Mechanism	Market Entry	Status
Capmatinib (INIMIA)	Novartis	MET inhibitor	Approved (2019, FDA/EU)	Established
Capertinib	Novartis	MET inhibitor	Approved	Established
Savolitinib	Beijing Sinopharm	MET inhibitor	Clinical approval in China	Emerging

3. Pricing and Reimbursement

• List price (~$13,000/month) comparable with other NSCLC targeted therapies.
• Reimbursement driven by comprehensive genomic testing infrastructure and payer policies.

4. Diagnostic Testing and Biomarker Development

• Companion diagnostics, primarily NGS panels, crucial for identifying eligible patients.
• Growing integration of precision oncology testing boosts market penetration.

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How Does TEPMETKO’s Market Penetration Look?

Market Penetration Factors:

Factor	Status	Implication
FDA Approval	Achieved	Facilitates initial commercialization
Clinical Adoption	Growing	Driven by awareness, companion diagnostics
Physician Awareness	Moderate	Ongoing educational campaigns needed
Insurance Coverage	Improving	Key to broader access

Estimated Peak Market Share:
Based on current data, TEPMETKO aims for approximately 15-20% of METex14 NSCLC patients within 5 years post-launch, capturing a significant share from existing therapies and off-label use.

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What Are the Financial Projections for TEPMETKO?

Revenue Forecast Summary (2023–2027)

Year	Total Patients (Worldwide)	Estimated Treated Patients	Average Selling Price (ASP)	Projected Revenue	Growth Rate
2023	20,000	1,500	$13,000/month	~$234 million	—
2024	25,000	2,000	$13,000/month	~$312 million	33%
2025	30,000	3,000	$13,000/month	~$468 million	50%
2026	40,000	4,500	$13,000/month	~$702 million	50%
2027	50,000	6,000	$13,000/month	~$936 million	33%

Note: Assumes continued growth driven by increased diagnostics, expanded geographic access, and clinical adoption.

Financial Drivers

• Volume growth driven by increased testing & diagnostics.
• Pricing stability with potential for discounts based on volume negotiations.
• Market expansion into additional indications (e.g., other MET-driven tumors).

Profitability Expectations

• Margins are expected to improve as production scales.
• R&D investments decreasing post-launch; focus shifts to maximizing existing indications.
• Potential for biosimilar entrance remains distant due to strong patent protection.

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What Are the Patent and Regulatory Considerations?

Aspect	Details	Impact
Patent Portfolio	Expiry projected around 2035	Market exclusivity persists for ~12 years post-launch
Data Exclusivity	Market exclusivity period till 2032	Delays generic entry
Orphan Drug Status	No	No additional benefits, but accelerates approvals

Regulatory Pathway:
Continued submission for additional indications and expansion into pediatric populations expected, broadening market scope.

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How does TEPMETKO Compare with Competitors?

Feature	TEPMETKO	Capmatinib	Savolitinib
Approval Status	Recently approved	Approved	Approved in China
Indications	MET exon 14 NSCLC	MET exon 14 NSCLC	MET exon 14 NSCLC (China)
Response Rate	46% ORR	39-54% ORR	Pending/Similar
Side Effect Profile	Favorable	Similar	Similar
Pricing	~$13K/month	~$13K/month	Similar

Implication: TEPMETKO’s competitive edge depends on real-world efficacy, safety, and geographic market penetration.

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What Challenges Could Impact Market Dynamics?

1. Market Competition

• Entry of next-generation MET inhibitors with improved efficacy or safety.
• Off-label use of other TKIs, such as cabozantinib.

2. Diagnostic Access

• Limited access to comprehensive genomic testing in emerging markets constrains market expansion.
• Variability in molecular testing policies.

3. Resistance Mechanisms

• Acquired resistance to TEPMETKO may limit durability, necessitating combination therapies or next-generation inhibitors.

4. Price and Reimbursement Pressures

• Payer negotiations could result in price adjustments, affecting revenue projections.

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What Is the Overall Financial Trajectory?

Considering current market data, competitive positioning, and forecasted growth, TEPMETKO is poised to generate nearly $1 billion in annual revenue by 2027. Growth will primarily stem from increased penetration of METex14 NSCLC patients, supplemented by expanding indications and geographic markets.

Year	Revenue (Estimated)	Key Drivers
2022	~$50 million	Launch effect, initial adoption
2023	~$234 million	Increased testing, physician familiarity
2024	~$312 million	Broader adoption, early markets expansion
2025	~$468 million	Peak utilization + new markets
2026	~$702 million	Maturation, global reach
2027	~$936 million	Market steady-state, new indications

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Key Takeaways

• TEPMETKO’s success hinges on its niche targeting MET exon 14 skipping mutations in NSCLC, an area of high unmet need.
• Regulatory approvals and companion diagnostics are instrumental in market access and growth.
• Competitive landscape includes established agents like capmatinib, but TEPMETKO benefits from early approval and promising clinical efficacy.
• The financial trajectory forecasts a trajectory toward nearly $1 billion in annual revenues within five years, assuming sustained market growth.
• Challenges include diagnostic access disparities, evolving resistance, and competitive pressures.

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FAQs

1. How does TEPMETKO’s efficacy compare to existing MET inhibitors?
TEPMETKO demonstrated an objective response rate (ORR) of approximately 46% in clinical trials, comparable or slightly superior to other approved agents like capmatinib, with a favorable safety profile.

2. What are the major barriers to TEPMETKO’s market expansion?
Barriers include limited access to comprehensive genomic testing, competition from other targeted agents, potential resistance mechanisms, and reimbursement hurdles in certain regions.

3. How sustainable is TEPMETKO’s market position given patent protections?
Patent expiry is projected around 2035, providing approximately 12 years of exclusivity. Market share will depend on ongoing clinical data, diagnostic integration, and competition.

4. Are there any additional indications for TEPMETKO?
Yes, ongoing trials explore efficacy in other MET-driven cancers, such as gastric and papillary renal cell carcinoma, which may expand its therapeutic footprint.

5. How will global health disparities impact TEPMETKO’s sales?
Limited infrastructure for genomic testing and reimbursement policies in emerging markets may slow growth but also present opportunities once these barriers are addressed through partnerships and policy reforms.

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References

[1] U.S. Food and Drug Administration (FDA). TEPMETKO (tepotinib) approval announcement, May 2022.
[2] ClinicalTrials.gov. VISION (NCT03611868): A study of tepotinib in adult patients with advanced MET exon14 skipping mutations positive NSCLC.
[3] Novartis. Capmatinib clinical data and approvals, 2019.
[4] Market research reports on NSCLC and targeted therapy trends, 2022–2023.
[5] Industry analysis reports, FDA policies, and patent expiry timelines.

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This comprehensive analysis provides a strategic view of TEPMETKO’s market dynamics and financial prospects, equipping stakeholders to optimize development, marketing, and investment strategies.