Tepotinib hydrochloride - Generic Drug Details

What are the generic 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

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.

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

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

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	9,284,300		Y
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
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	8,580,781		Y	Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,921,357		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
Spain	2614283
Slovenia	2164843
Colombia	6270257
Japan	2010532774
Hong Kong	1142891
South Africa	201001023	PYRIMIDINYL PYRIDAZINONE DERIVATES
Hungary	S2200024

Supplementary Protection Certificates for tepotinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2164843	28/2022	Austria		PRODUCT NAME: TEPOTINIB UND PHARMAZEUTISCH VERWENDBARE SOLVATE, SALZE, TAUTOMERE UND STEREOISOMERE DAVON; REGISTRATION NO/DATE: EU/1/21/1596 (MITTEILUNG) 20220217
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
2164843	2290029-4	Sweden		PRODUCT NAME: TEPOTINIB AND PHARMACEUTICALLY USABLE SOLVATES, SALTS, AND TAUTOMERS THEROF; REG. 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	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	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 Tepotinib Hydrochloride

Last updated: February 20, 2026

What is the current market landscape for Tepotinib Hydrochloride?

Tepotinib hydrochloride is a selective MET inhibitor developed primarily for treating non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. It is marketed by Merck KGaA under the brand name Tepmetko in the United States. Regulatory approval has been granted in the U.S., Japan, and other regions, with ongoing submissions for additional indications.

The drug’s market is driven by a growing prevalence of MET exon 14 skipping mutations in NSCLC. The global NSCLC market exceeds $20 billion annually, with MET inhibitors accounting for a rapidly increasing share as biomarker-driven therapies expand.

How does regulatory approval and pipeline influence market potential?

In 2020, the U.S. Food and Drug Administration (FDA) approved Tepotinib based on phase 2 clinical data. Japan’s Ministry of Health, Labour and Welfare (MHLW) approved it in 2021. The European Medicines Agency (EMA) has not yet approved Tepotinib but has designated it as an orphan drug in several regions.

The drug competes with alternatives like capmatinib (Tabrecta) and crizotinib, which target similar patient populations. The pipeline for MET inhibitors includes both targeted small molecules and monoclonal antibodies, influencing the competitive landscape.

What is the sales trajectory and revenue forecast?

Initial sales from Tepmetko in the US have been modest, totaling approximately $50 million in 2022. As clinical trials demonstrate efficacy in additional indications, sales are expected to increase. Merck KGaA projected revenues could reach $100 million in 2023 and surpass $500 million by 2027, assuming expansion into second-line settings and additional geographies.

Market penetration remains limited by factors such as:

• Competition from established therapies
• Cost and reimbursement issues
• The relatively small subset of MET exon 14 patients within NSCLC

How does manufacturing capacity and pricing impact revenue?

Manufacturing capacity for Tepotinib has scaled in response to growing demand. The average wholesale price (AWP) in the U.S. is approximately $10,000 per month per patient. Reimbursement policies vary, affecting patient access and net sales.

Pricing strategies will influence profitability; the drug's high cost limits adoption in regions with constrained healthcare budgets. Cost of goods sold (COGS) remains moderate due to its small molecule structure, but expansion into broader indications or combination therapies could reshape margins.

What are the key factors influencing market growth?

• Biomarker identification: Improved detection of MET exon 14 skipping mutations enhances patient selection.
• Regulatory developments: Approvals across more regions expand the market.
• Clinical trial results: Positive data in combination therapies may increase use.
• Competitive dynamics: Approval or entry of rival drugs impacts market share.
• Reimbursement landscape: Favorable policies accelerate adoption.

What opportunities and risks exist?

Opportunities:

• Expanding indications beyond NSCLC.
• Growing awareness and testing for MET mutations.
• Strategic partnerships for combination therapy development.

Risks:

• Intense competition from other MET inhibitors.
• Delays or failures in clinical development.
• Regulatory hurdles or unfavorable reimbursement decisions.
• Limited patient population size constrains revenue potential.

Conclusion

Tepotinib hydrochloride operates in a niche but expanding segment of targeted lung cancer therapies. Its financial trajectory relies heavily on regulatory approvals, clinical success, and competitive positioning. Revenue prospects depend on market penetration, pricing, and pipeline developments.

Key Takeaways

• Tepotinib is FDA- and MHLW-approved for MET exon 14 skipping NSCLC; potential expansion is under consideration.
• Sales are modest currently, with substantial growth forecasted upon approval in additional regions and indications.
• Competition from similar agents and reimbursement policies are critical determinants of market share.
• Pricing strategies and manufacturing costs influence margins and revenue potential.
• Clinical trial outcomes and biomarker testing advancements shape future opportunities.

FAQs

1. What is the primary indication for Tepotinib?
   MET exon 14 skipping mutation-positive non-small cell lung cancer.

2. How does Tepotinib compare with similar drugs like capmatinib?
   Both target MET exon 14 mutations; Tepotinib has FDA approval and a comparable efficacy profile but faces competition in market share.

3. Are there ongoing trials for other cancers?
   Yes, trials are investigating Tepotinib in other solid tumors with MET alterations, including gastric and brain cancers.

4. What are the main barriers to market expansion?
   Limited indication scope, high drug costs, competition, and the small patient population.

5. What factors could accelerate revenue growth?
   Approval of additional indications, improved biomarker testing, and partnership deals for combination therapies.

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References

[1] U.S. Food and Drug Administration. (2020). Tepmetko approval letter. Retrieved from https://www.fda.gov

[2] Merck KGaA. (2022). Annual report 2022. Retrieved from https://www.emdgroup.com

[3] European Medicines Agency. (2023). Orphan designation data. Retrieved from https://www.ema.europa.eu