Tepotinib hydrochloride - Generic Drug Details

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.

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
SWOG Cancer Research Network	PHASE2
Eli Lilly and Company	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			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			Y
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes

International Patents for tepotinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2526352
Japan	5426543
Lithuania	2754660
Singapore	183739	PYRIDAZINONE DERIVATES

Supplementary Protection Certificates for tepotinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	202240015	Slovenia		PRODUCT NAME: TEPOTINIB AND ITS PHARMACEUTICALLY USEFUL SOLVATES, SALTS, TAUTOMERS AND STEREOISOMERS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1596/001; DATE OF NATIONAL AUTHORISATION: 20220216; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2164843	LUC00264	Luxembourg		PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1596 20220217
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: April 16, 2026

What is Tepotinib Hydrochloride?

Tepotinib hydrochloride is a selective MET receptor tyrosine kinase inhibitor developed by Merck (MSD). It targets MET gene amplifications and exon 14 skipping mutations in non-small cell lung cancer (NSCLC). Approved in the U.S. via accelerated approval in 2021, it is indicated for MET exon 14 skipping mutation-positive NSCLC.

Market Size and Adoption

Current Market Estimates

• Global NSCLC market (2022): Estimated at USD 20 billion, with targeted therapies representing approximately 10% (USD 2 billion).
• Tepotinib's market share (2022): Estimated at 3%, roughly USD 600 million, driven by its approval status and competitive landscape.

Competitive Position

• Main competitors: Capmatinib (Belgium's Incyte and Novartis), approved by FDA in 2020; Crizotinib (Pfizer), for ALK and ROS1 mutations.
• Market share: Capmatinib holds approximately 60% of the targeted MET inhibitor market; tepotinib holds about 20-25%; other competitors share the rest.

Uptake Factors

• Regulatory reviews: FDA and EMA (EMA approved in 2022) approvals support broader acceptance.
• Physician adoption: Limited real-world data; early adoption is primarily in the U.S. and Europe.
• Pricing: USD 14,000–USD 16,000 per month, aligning with other targeted therapies.

Revenue Trends and Projections

Year	Estimated Global Revenue	Notes
2022	USD 600 million	Initial uptake post-approval
2023	USD 700 million	Growing adoption, expanded approvals
2024	USD 900 million	Increased market penetration
2025	USD 1.2 billion	Expected rise due to broader use

Key Factors Influencing Growth

• Market expansion: Potential approvals for additional indications, e.g., MET amplification in other cancers.
• Regulatory influence: EMA approval could boost European sales; potential approvals in Asia.
• Competitive pressure: Capmatinib's market dominance remains a challenge.
• Manufacturing and supply chain: Ongoing stability and capacity will influence sales.

Financial Trajectory Insights

Revenue Drivers

• Pipeline maturation: Near-term revenue depends on initial uptake and eventual growth in second-line settings.
• Pricing dynamics: Stable pricing supports revenue; price erosion unlikely in the short term.
• Market penetration: Adoption speed influences revenue growth; early-stage adoption consistent with other targeted therapies.

Risks and Challenges

• Market competition: Capmatinib's existing market share limits expansion opportunities.
• Regulatory delays: Potential delays in approval for new indications or regions could hinder growth.
• Pricing pressures: Payers may negotiate discounts or enforce formulary restrictions.

Investment implications

• R&D spend: Continued investment in broader indications and combination regimens.
• Partnerships: Collaborations for distribution in emerging markets could enhance revenue.
• Pricing strategies: Maintaining premium pricing against competitors is critical.

Policy and Regulatory Environment

• FDA accelerated approval (2021): Allowed fast-track access but requires confirmatory trials.
• EMA approval (2022): Clarifies market access within Europe.
• Potential for label expansion: Based on ongoing trials, with possible approvals for MET alterations in other tumor types, such as gastric or esophageal cancers.

Long-term Outlook

• Market growth: Anticipated compound annual growth rate (CAGR) between 8-12% over the next five years.
• Pipeline development: Clinical trials for combination therapies and new indications may influence future revenue streams.
• Patent landscape: Patent expiry is expected around 2030, after which generic competition could pressure prices and revenues.

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Key Takeaways

• Tepotinib is a targeted therapy for MET-driven NSCLC with current sales estimated at USD 600 million (2022), projected to grow to USD 1.2 billion by 2025.
• Market growth is influenced by regulatory approvals, physician adoption, competitive dynamics, and potential new indications.
• Challenges include competition from Capmatinib, pricing pressures, and market penetration speed.
• Regulatory landscapes in the U.S., Europe, and emerging markets shape the potential revenue trajectory.
• Pipeline expansion and combination drug strategies are critical for sustaining long-term growth.

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FAQs

1. What factors most influence tepotinib's market share?
Physician adoption, regulatory approvals, pricing, and competitive offerings like Capmatinib primarily shape market share.

2. How does regulatory approval impact revenue?
Accelerated approval offers early market access, with eventual approval expanding patient base and sales. Delays or rejections limit revenue growth.

3. What is the potential for expanding tepotinib's indications?
Clinical trials are ongoing for use in other cancers with MET alterations, which could significantly increase future revenue if approved.

4. How does pricing compare to competitors?
Tepotinib is priced around USD 14,000–USD 16,000 monthly, similar to capmatinib, aligning with targeted therapies for advanced cancers.

5. What risks could affect tepotinib's financial trajectory?
Market competition, patent expiry, regulatory delays, and payer negotiability influence long-term revenue prospects.

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References

1. U.S. Food and Drug Administration. (2021). FDA grants accelerated approval to Tepotinib for MET exon 14 skipping mutation-positive NSCLC.
2. European Medicines Agency. (2022). EMA approves Tepotinib for MET-positive NSCLC.
3. MarketResearch.com. (2022). Global NSCLC targeted therapy market overview.
4. Incyte Corporation. (2020). Capmatinib approved for MET exon 14 skipping mutation-positive NSCLC.
5. IQVIA. (2022). Oncology drug sales and market share data.