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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-six patent family members in thirty-five 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 will be eligible for patent challenges on February 3, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for TEPMETKO

International Patents:	76
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	20
Drug Prices:	Drug price information 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
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

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

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
Slovenia	2754660
Croatia	P20150031
Portugal	2164844
Denmark	2164843
Slovenia	2164843
Colombia	6270257	DERIVADOS DE PIRIDAZINONA

Supplementary Protection Certificates for TEPMETKO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
2164843	22C1024	France		PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; REGISTRATION NO/DATE: EU/1/21/1596 20220217

TEPMETKO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TEPMETKO

Introduction

TEPMETKO (tepotinib) is a groundbreaking drug developed by Merck KGaA, Darmstadt, Germany, specifically designed to treat adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations. This article delves into the market dynamics and financial trajectory of TEPMETKO, highlighting its regulatory approvals, clinical significance, and financial impact.

Regulatory Approvals

TEPMETKO has garnered significant regulatory milestones globally. It was the first oral MET inhibitor to receive regulatory approval anywhere in the world, starting with its approval in Japan in March 2020 for the treatment of advanced NSCLC with MET gene alterations[1][4].

FDA Approval

In February 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to TEPMETKO for the treatment of adult patients with metastatic NSCLC with MET exon 14 skipping alterations. This approval was based on the overall response rate and duration of response observed in the VISION study[4].

European Commission Approval

The European Commission approved TEPMETKO in February 2022 for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping. This approval was also based on the Phase II results from the VISION study, which demonstrated consistent responses across lines of therapy[1].

Clinical Significance

TEPMETKO's clinical significance lies in its targeted mechanism of action against the MET signaling pathway, which is crucial in certain aggressive tumors. The drug has shown consistent and durable responses in both treatment-naive and previously treated patients with METex14 positive NSCLC in the VISION study[1][4].

Patient Impact

The approval of TEPMETKO represents a significant advance for patients with this specific type of lung cancer, offering a once-daily oral treatment option that can improve outcomes in a disease with a poor prognosis. As noted by Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business sector of Merck KGaA, "This approval of TEPMETKO by the FDA is an important milestone on our mission to significantly improve the treatment of cancer where MET plays a driving role"[4].

Market Dynamics

Competitive Landscape

TEPMETKO is the first and only oral MET inhibitor approved for the treatment of NSCLC with METex14 skipping alterations, giving it a unique position in the market. This exclusivity allows Merck KGaA to capture a significant share of the market for this specific patient population[1][4].

Global Availability

TEPMETKO is available in several countries and is under review by various other regulatory authorities globally. Its availability in a pilot zone of China, in line with the government's policy to drive early access for innovative medicines approved outside of China, further expands its market reach[1].

Financial Trajectory

Revenue Growth

The approval and subsequent market entry of TEPMETKO have contributed to the revenue growth of Merck KGaA's Healthcare sector. In 2021, the company reported strong sales growth, with TEPMETKO being one of the key contributors to this growth, especially within the oncology segment[2].

Financial Performance

Merck KGaA's financial reports indicate a positive impact from the sales of TEPMETKO. For instance, in the Q1 2024 results, the Healthcare sector saw a sales growth of +10%, with positive contributions from all franchises, including TEPMETKO[5].

Investment and Growth Targets

Merck KGaA has set ambitious growth targets, including the '25 by 25' strategy, aiming for around €25 billion in Group sales by 2025. This involves significant investments in research and development, capital expenditure, and acquisitions. The success of TEPMETKO aligns with these growth ambitions, contributing to the company's overall financial performance and strategic goals[2].

Key Financial Indicators

EBITDA and Net Sales

The company's EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) has seen significant growth, partly due to the strong sales momentum of TEPMETKO. In Q1 2024, the Healthcare sector's EBITDA pre-adjustments increased by +28% organically, driven by higher sales and the regaining of full rights for another oncology medicine, Bavencio[5].

Research and Development

Merck KGaA continues to invest heavily in research and development, with a mid-term ambition to maintain an R&D ratio in the low twenties percent. The success of TEPMETKO justifies these investments, as it represents a significant advancement in targeted cancer therapy[2][5].

Conclusion

TEPMETKO has marked a significant milestone in the treatment of NSCLC with METex14 skipping alterations, offering patients a targeted and effective oral treatment option. Its regulatory approvals, clinical efficacy, and financial performance all contribute to its importance in the market.

Key Takeaways

• First and Only Oral MET Inhibitor: TEPMETKO is the first oral MET inhibitor approved globally for treating NSCLC with METex14 skipping alterations.
• Global Regulatory Approvals: Approved by FDA, European Commission, and available in several countries.
• Clinical Significance: Demonstrated consistent and durable responses in both treatment-naive and previously treated patients.
• Market Dynamics: Unique market position due to exclusivity, contributing to revenue growth.
• Financial Trajectory: Positive impact on Merck KGaA's revenue and EBITDA, aligning with the company's growth targets.

FAQs

What is TEPMETKO used for?

TEPMETKO (tepotinib) is used for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.

Who approved TEPMETKO?

TEPMETKO was approved by the U.S. Food and Drug Administration (FDA) in February 2021 and by the European Commission in February 2022.

How is TEPMETKO administered?

TEPMETKO is administered as a once-daily oral dose of two 225 mg tablets (450 mg).

What is the clinical significance of TEPMETKO?

TEPMETKO has shown consistent and durable responses in both treatment-naive and previously treated patients with METex14 positive NSCLC, offering a significant advance in the treatment of this aggressive form of lung cancer.

How has TEPMETKO impacted Merck KGaA's financial performance?

TEPMETKO has contributed to the revenue growth and increased EBITDA of Merck KGaA's Healthcare sector, aligning with the company's ambitious growth targets.

Sources

1. Merck KGaA - TEPMETKO EC Approval - News - Merck KGaA
2. Merck KGaA - Annual Report 2021 - EMD Group
3. Merck KGaA - Annual Financial Statements - 2021 - Merck KGaA
4. Merck KGaA - FDA Approves TEPMETKO - News - Merck KGaA
5. Merck KGaA - Presentation Media Q1 2024 (PDF) - EMD Group