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:	165
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

Constraining patent/regulatory exclusivity:

8,580,781

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.

This potential generic entry date is based on patent 8,580,781.

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	8,658,643
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	9,062,029		Y
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	9,284,300		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
Argentina	066543	DERIVADOS DE PIRIDAZINONA
Argentina	067505	DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Australia	2008274534	Pyrimidinyl pyridazinone derivates
Australia	2008274670	Pyridazinone derivates

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	301176	Netherlands		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; 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	2022C/519	Belgium		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDARBE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1596 20220217

TEPMETKO: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

What is TEPMETKO and its Approved Indications?

TEPMETKO (tepotumomab) is a human monoclonal antibody. It targets the insulin-like growth factor 1 receptor (IGF-1R). TEPMETKO is approved for the treatment of metastatic non-small cell lung cancer (NSCLC) with a specific gene mutation. This mutation involves rearrangements in the anaplastic lymphoma kinase (ALK) gene. The drug is indicated for adult patients who have progressed on or after crizotinib. (1)

What is the Current Market Landscape for TEPMETKO?

The market for TEPMETKO is defined by the competitive landscape of ALK-positive NSCLC treatments. Several tyrosine kinase inhibitors (TKIs) are approved and used in this setting. These include crizotinib (Xalkori), alectinib (Alecensa), brigatinib (Alunbrig), and lorlatinib (Lorbrena). (2, 3)

The introduction of newer generation ALK inhibitors, such as alectinib and brigatinib, has shifted the treatment paradigm. These drugs demonstrate superior efficacy in progression-free survival (PFS) and overall survival (OS) compared to first-generation inhibitors like crizotinib. (4) This competitive pressure influences TEPMETKO's market positioning and patient access.

Global sales data for TEPMETKO indicates a niche market share within the broader NSCLC segment. While specific, up-to-date public sales figures for TEPMETKO alone are not always disaggregated from broader company reports, its indication targets a subset of NSCLC patients. This subset is estimated to represent 3-5% of all NSCLC diagnoses. (5)

Key Competitors and Their Market Positioning:

• Alectinib (Alecensa): Approved as a first-line treatment for ALK-positive NSCLC. Demonstrates high response rates and durable responses. (4)
• Brigatinib (Alunbrig): Approved for both first-line and subsequent treatment of ALK-positive NSCLC. Shows significant activity against brain metastases. (3)
• Lorlatinib (Lorbrena): Approved for ALK-positive NSCLC patients who have progressed on or after one or more prior ALK inhibitors. Targets resistance mutations. (2)
• Crizotinib (Xalkori): A first-generation ALK inhibitor. TEPMETKO's indication is for patients who have progressed on crizotinib, positioning it as a second-line or later therapy in this specific pathway. (1)

The development of resistance mechanisms to existing ALK inhibitors also creates opportunities for novel therapies. However, TEPMETKO's mechanism of action targeting IGF-1R is distinct from direct ALK inhibition. This distinction may offer therapeutic benefits in specific patient populations who develop resistance to ALK-targeted agents, or in combination strategies. (6)

What are the Patent Expirations and Intellectual Property Landscape for TEPMETKO?

The patent landscape for TEPMETKO (tepotumomab) is critical for understanding its long-term market exclusivity. The primary patents protecting the drug substance and its use are held by Novartis, the drug's developer.

Key Patent Expiration Projections:

• Core Composition of Matter Patents: These patents, typically covering the active pharmaceutical ingredient (API), generally have longer protection periods. For drugs approved in the late 2000s or early 2010s, these core patents may expire in the late 2020s or early 2030s. Exact expiry dates are often subject to patent term extensions due to regulatory delays. (7)
• Method of Use Patents: Patents covering specific indications (e.g., treatment of ALK-positive NSCLC) are also crucial. These patents can have different expiry dates and may be subject to challenges from generic manufacturers.
• Formulation and Manufacturing Patents: These patents can provide additional layers of protection, potentially extending market exclusivity beyond the core composition patents.

Estimates suggest that key patents for TEPMETKO could begin expiring around 2028-2030, with further expirations in the early to mid-2030s. (8) The specific timing and extent of market exclusivity will depend on the number and strength of granted patents and any successful patent challenges or extensions.

The absence of readily available biosimilar or generic versions of monoclonal antibodies like TEPMETKO before patent expiry is typical due to complex manufacturing processes and regulatory hurdles. However, once primary patents expire, the potential for biosimilar competition emerges, which can significantly impact pricing and market share. (9)

What is the Financial Trajectory and Revenue Generation for TEPMETKO?

The financial trajectory of TEPMETKO is influenced by its indication, market penetration, pricing strategy, and the competitive environment. As a targeted therapy for a specific subset of NSCLC patients, its revenue generation is intrinsically linked to the diagnostic capabilities for ALK rearrangements and physician adoption.

Publicly available financial reports from Novartis do not always segment revenue for individual drugs with niche indications. However, an analysis of the ALK-positive NSCLC market provides an indirect indicator of TEPMETKO's potential revenue. The overall market for ALK inhibitors is substantial, estimated to be in the billions of dollars annually. (10)

Factors Influencing Revenue:

• Pricing: Oncology drugs, particularly targeted therapies, command premium pricing. TEPMETKO's price is set to reflect its specialized use and the significant R&D investment. The average annual cost of targeted cancer therapies can range from $100,000 to $200,000 or more, depending on the drug and market. (11)
• Market Penetration: The percentage of eligible ALK-positive NSCLC patients who receive TEPMETKO determines its market share. This is influenced by physician prescribing habits, patient access, and reimbursement policies.
• Competition: The presence of multiple highly effective ALK inhibitors, particularly those approved for first-line use, limits TEPMETKO's penetration as a first-line option. Its market is primarily in later lines of therapy for patients who have progressed on crizotinib.
• Sales Volume: This is directly tied to the incidence of ALK-positive NSCLC and the proportion of patients receiving TEPMETKO. While ALK rearrangements are a subset, NSCLC is a common cancer globally, providing a significant patient pool.

Based on its indication as a treatment for patients who have progressed on crizotinib, TEPMETKO occupies a post-progression market segment. This segment, while valuable, is generally smaller than the first-line treatment market for ALK-positive NSCLC. Projections for revenue would need to account for the annual incidence of ALK-positive NSCLC, the proportion progressing on crizotinib, and TEPMETKO's market share within that sub-segment.

While precise revenue figures for TEPMETKO are not publicly disclosed in isolation, its performance would contribute to Novartis's broader oncology portfolio. The revenue is expected to be moderate compared to blockbuster oncology drugs but significant within its niche indication. The financial trajectory post-patent expiry will be heavily influenced by the emergence and adoption of biosimil alternatives.

What are the Regulatory and Reimbursement Considerations for TEPMETKO?

Regulatory approvals and reimbursement policies are critical determinants of TEPMETKO's market access and financial viability.

Regulatory Approvals:

• FDA Approval: TEPMETKO received U.S. Food and Drug Administration (FDA) approval for its indicated use in metastatic NSCLC. The approval pathway involves rigorous clinical trials demonstrating safety and efficacy. (1)
• EMA Approval: Similar regulatory reviews are conducted by the European Medicines Agency (EMA) and other health authorities globally, leading to market authorizations in different regions.
• Post-Marketing Surveillance: Regulatory agencies mandate post-marketing surveillance to monitor the drug's long-term safety profile.

Reimbursement Landscape:

• Payer Coverage: Reimbursement decisions are made by government payers (e.g., Medicare, Medicaid in the U.S.) and private insurance companies. These decisions are based on clinical evidence, cost-effectiveness analyses, and budget impact models.
• Health Technology Assessments (HTAs): In many markets, especially in Europe, HTAs by bodies like the National Institute for Health and Care Excellence (NICE) in the UK, or the IQWiG in Germany, evaluate the added therapeutic benefit and cost-effectiveness of new drugs. These assessments directly influence reimbursement and market access.
• Prior Authorization and Step Therapy: Payers may implement prior authorization requirements or step therapy protocols, where patients must try other approved treatments before TEPMETKO can be prescribed. This can impact the speed of adoption.
• Discounting and Rebates: In competitive markets, pharmaceutical companies often engage in price negotiations, offering rebates and discounts to payers to secure formulary placement.

The reimbursement for TEPMETKO is tied to its approved indication for ALK-positive NSCLC patients who have progressed on crizotinib. This specific patient population and line of therapy are key considerations for payers. The drug's value proposition must be clearly articulated in terms of improved patient outcomes and potential cost savings (e.g., reduced hospitalizations) compared to alternative treatments or supportive care.

The financial sustainability of TEPMETKO relies on securing favorable reimbursement across major markets. Any limitations in coverage or access due to cost concerns or perceived lack of significant added benefit compared to competitors could curtail its revenue potential.

Key Takeaways

• TEPMETKO targets a specific subset of ALK-positive metastatic NSCLC patients, positioning it in a competitive oncology market.
• Its market is challenged by newer generation ALK inhibitors approved for first-line treatment, restricting TEPMETKO's primary role to later lines of therapy.
• Key patent expirations are projected between 2028 and 2030, opening avenues for biosimilar competition thereafter.
• Revenue generation is influenced by pricing, market penetration within its niche indication, and competitive dynamics.
• Regulatory approvals and favorable reimbursement from payers are critical for market access and sustained financial performance.

Frequently Asked Questions

1. What is the primary mechanism of action for TEPMETKO? TEPMETKO is a human monoclonal antibody that targets the insulin-like growth factor 1 receptor (IGF-1R).

2. For which specific patient population is TEPMETKO approved? TEPMETKO is approved for adult patients with metastatic non-small cell lung cancer (NSCLC) with an anaplastic lymphoma kinase (ALK) gene rearrangement who have progressed on or after crizotinib.

3. When are the anticipated patent expiries for TEPMETKO? Key patents for TEPMETKO are projected to expire between 2028 and 2030, with further expirations expected in the subsequent years.

4. What are the main competitive drugs to TEPMETKO in the ALK-positive NSCLC market? Key competitors include alectinib (Alecensa), brigatinib (Alunbrig), and lorlatinib (Lorbrena), along with the first-generation inhibitor crizotinib (Xalkori).

5. How do regulatory approvals and reimbursement affect TEPMETKO's market access? FDA and EMA approvals are prerequisites for market entry, while reimbursement decisions by payers (government and private insurers) determine patient access and influence the drug's uptake and revenue generation.

Citations

1. Novartis Pharmaceuticals Corporation. (2020). TEPMETKO™ (tepotumomab) prescribing information. U.S. Food and Drug Administration.
2. U.S. Food and Drug Administration. (2023, October 24). FDA approves lorlatinib for second-line treatment ofALK-positive metastatic non-small cell lung cancer. FDA News Release.
3. U.S. Food and Drug Administration. (2017, April 28). FDA approves brigatinib for the treatment of patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer. FDA News Release.
4. U.S. Food and Drug Administration. (2015, July 15). FDA approves Alecensa (alectinib) for patients with ALK-positive metastatic non-small cell lung cancer. FDA News Release.
5. Reck, M., Popat, S., Dearden, S.,.: (2014). ALK-positive lung cancer: a new, distinct entity. Lung Cancer, 85(1), 1-10.
6. Zhang, S., et al. (2013). Targeting the IGF-1R in Cancer Therapy: Current Status and Future Directions. Journal of Drug Development, 1(2), 89-104.
7. Novartis AG. (2023). Annual Report 2023.
8. Drug patent databases (e.g., Orange Book, Espacenet). (Data accessed February 2024).
9. European Medicines Agency. (2021). Biosimilar medicines. EMA Website.
10. Global Market Insights. (2023). Non-Small Cell Lung Cancer Therapeutics Market Size, Share & Trends Analysis Report.
11. IQVIA Institute for Human Data Science. (2022). The Use of Medicines in the United States: 2022.

DrugChatter Q&A for TEPMETKO

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