TEPMETKO Drug Patent Profile

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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.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. There is one drug master file entry for this compound. 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

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	209
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
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

Finland

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
Brazil	PI0813707	DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Brazil	PI0814616	DERIVADOS DE PIRIDAZINONA

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
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	CA 2022 00021	Denmark		PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217

TEPMETKO Market Dynamics, Sales Trajectory, Patent Risk, and Competitive Outlook

Last updated: August 26, 2026

Tepmetko, the brand name for tepotinib, is an oral MET inhibitor marketed by EMD Serono in the United States and Merck KGaA internationally. Its commercial opportunity is concentrated in metastatic non-small-cell lung cancer (NSCLC) with MET exon 14 skipping alterations, a biomarker-defined population representing roughly 3% to 4% of NSCLC cases. Tepmetko has secured regulatory approvals in Japan, the United States, and Europe, but its revenue potential is constrained by the small eligible population, diagnostic testing rates, competition from Tabrecta, and the limited disclosure of product-level sales by Merck KGaA.

What is Tepmetko and what indication does it treat?

Tepmetko contains tepotinib hydrochloride hydrate, a selective oral inhibitor of the MET receptor tyrosine kinase. It is supplied as a 225 mg tablet and administered at a recommended dose of 450 mg once daily with food.

The FDA approved Tepmetko on February 3, 2021, for adults with metastatic NSCLC whose tumors have MET exon 14 skipping alterations. The approval was granted under the accelerated-approval pathway based primarily on overall response rate and duration of response in the VISION clinical trial.[1]

The approved population is defined by a molecular alteration rather than by histology alone. This limits the addressable market but allows treatment selection through molecular diagnostic testing.

Key regulatory milestones

Date	Event	Market significance
March 2020	Japanese approval	First major-market approval for tepotinib
February 2021	FDA accelerated approval	Entry into the U.S. MET exon 14 NSCLC market
February 2022	European Commission conditional marketing authorization	Access to European Union markets
2021 onward	Commercial rollout by EMD Serono and Merck KGaA	Expansion through oncology and diagnostic channels

The FDA label requires identification of MET exon 14 skipping alterations using an FDA-approved test. The approval was supported by data from both tissue and liquid-biopsy testing cohorts.[1]

How large is the Tepmetko market?

The market is small in patient count but commercially valuable because of high oncology pricing and the absence of many targeted therapies for MET exon 14 disease.

MET exon 14 skipping alterations occur most often in older patients with nonsquamous NSCLC, although they can occur across histologic subtypes. Published estimates generally place the alteration frequency at approximately 3% to 4% of NSCLC cases, with some studies reporting higher or lower rates depending on the testing platform and patient population.[2]

The commercial market depends on five variables:

1. The number of patients diagnosed with metastatic NSCLC.
2. The percentage receiving broad molecular profiling.
3. The detection rate for MET exon 14 skipping.
4. Treatment persistence and sequencing.
5. Relative uptake versus Tabrecta and immunotherapy-based regimens.

Broad next-generation sequencing has increased the probability that MET exon 14 alterations are identified before first-line treatment. Testing remains uneven across community oncology settings, creating a larger commercial gap than the underlying biology alone would suggest.

Addressable-patient estimate

A practical U.S. market framework is:

Market step	Approximate implication
Annual U.S. incident lung cancer cases	More than 200,000
NSCLC share	Approximately 80% to 85%
Metastatic or recurrent treatment population	Substantially smaller than total NSCLC
MET exon 14 skipping prevalence	Approximately 3% to 4% of NSCLC
Commercially testable and treatable population	A low-thousands annual population, depending on testing and line of therapy

Public companies do not consistently disclose the exact number of Tepmetko-treated patients. Market-research estimates should therefore be treated as directional rather than as audited demand data.

What are Tepmetko’s sales and financial trajectory?

Merck KGaA does not consistently disclose Tepmetko revenue as a standalone line item in its group financial statements. The product is included in the Healthcare business, which also contains established franchises such as Erbitux, Bavencio, Mavenclad, and other products.

This limits precise calculation of Tepmetko’s annual sales, growth rate, gross margin, and contribution to group earnings. The available financial signal is commercial rather than fully quantitative: Tepmetko has become an established targeted-oncology product, but it has not reached the revenue scale of Merck KGaA’s largest pharmaceutical assets.

Revenue trajectory

Period	Financial interpretation
2020	Pre-U.S. launch period; Japan approval established initial commercial base
2021	U.S. launch created the principal near-term growth opportunity
2022	European availability expanded geographic reach
2023-2024	Growth depended on diagnostic penetration, treatment-line adoption, and share against Tabrecta
2025 onward	Market maturation, potential generic challenges, and confirmatory regulatory requirements become more important

Tepmetko’s economic profile is typical of a biomarker-defined oncology drug: high revenue per treated patient, limited volume, and substantial dependence on physician testing behavior.

The U.S. list price has been reported in the range of approximately $17,000 to $18,000 per month, although net realized prices are lower because of rebates, discounts, government programs, and patient-support arrangements. Price alone does not determine revenue because treatment duration varies and many patients discontinue for progression or tolerability.

How does Tepmetko compare with Tabrecta?

Tabrecta, or capmatinib, is Tepmetko’s closest commercial competitor. Both drugs are oral, selective MET inhibitors approved for metastatic NSCLC with MET exon 14 skipping alterations.

Attribute	Tepmetko	Tabrecta
Active ingredient	Tepotinib	Capmatinib
Company	EMD Serono/Merck KGaA	Novartis
FDA approval	February 2021	May 2020
Target	MET	MET
Primary biomarker	MET exon 14 skipping alteration	MET exon 14 skipping alteration
Dosage form	Oral tablet	Oral tablet
Key trial	VISION	GEOMETRY mono-1
Principal differentiation	Strong liquid-biopsy and tissue-based VISION dataset; once-daily dosing	Earlier U.S. entry; established MET-focused commercial infrastructure

Cross-trial comparisons are unreliable because VISION and GEOMETRY mono-1 used different designs, populations, testing methods, and follow-up periods. Both drugs have demonstrated clinically meaningful activity in MET exon 14 NSCLC.

Competitive pressures

Tepmetko competes against:

• Tabrecta in the targeted MET inhibitor category.
• Platinum chemotherapy and immunotherapy in patients treated before or around biomarker confirmation.
• Clinical trials involving antibody-drug conjugates and other MET-directed therapies.
• Off-label or later-line use of other kinase inhibitors in selected cases.

The main commercial contest is between Tepmetko and Tabrecta, not between multiple fully interchangeable generics. Physician familiarity, diagnostic availability, adverse-event management, payer coverage, and dosing convenience can influence product selection.

What is the FDA regulatory status of Tepmetko?

Tepmetko received accelerated FDA approval. The approval was based on response-rate and duration-of-response data rather than a demonstrated overall-survival benefit in a randomized confirmatory study.

The VISION trial reported an objective response rate of approximately 46%, with a median duration of response of approximately 11 months in the principal efficacy population.[1]

Accelerated approval creates a continuing regulatory obligation. The sponsor must complete postmarketing work capable of confirming clinical benefit. Failure to verify benefit can lead to label restriction or withdrawal under the FDA accelerated-approval framework.

As of the latest broadly available public regulatory materials, Tepmetko’s central regulatory issue is not initial approval but the maintenance and confirmation of the indication.

What patents protect Tepmetko?

Tepmetko is protected through a combination of compound, formulation, pharmaceutical-composition, manufacturing, and potentially method-of-use patent rights. The relevant rights are likely distributed across international patent families owned or controlled by Merck KGaA or related entities.

The principal patent-risk categories are:

Patent category	Commercial purpose
Compound patents	Protect tepotinib and related chemical structures
Salt and crystalline-form patents	Protect the hydrochloride hydrate or other solid-state forms
Formulation patents	Protect tablet composition, stability, dissolution, or manufacturing characteristics
Method-of-use patents	Protect treatment of MET-altered cancers or specific patient populations
Manufacturing patents	Create process barriers against efficient generic production

The exact U.S. generic-entry date depends on the patents listed in the FDA Orange Book, patent-term adjustment, patent-term extension, pediatric exclusivity, and any Paragraph IV litigation or settlement. Public secondary sources have placed important tepotinib protection in the early-to-mid-2030s, but the controlling dates are the current Orange Book listings and applicable patent certificates.

What is the Orange Book status of Tepmetko?

Tepmetko is an FDA-approved small-molecule product and is therefore subject to the ANDA and Paragraph IV framework. It is not a biologic and does not receive the separate patent and exclusivity treatment applicable to biosimilars.

The practical Orange Book risks are:

• A generic applicant may file an ANDA with a Paragraph IV certification.
• The NDA holder may sue within the statutory period after receiving notice.
• A timely patent suit can trigger a 30-month stay of ANDA approval, subject to court and regulatory exceptions.
• A generic applicant may challenge composition, formulation, or use patents independently.

The presence of an Orange Book-listed patent does not guarantee that the patent will withstand invalidity or non-infringement challenges.

When does Tepmetko lose exclusivity?

Tepmetko’s exclusivity timeline has several layers.

Regulatory exclusivity

The FDA granted Tepmetko approval as a new molecular entity. Five-year NCE exclusivity generally prevents submission of an ANDA for four years and prevents approval for five years, subject to a Paragraph IV exception beginning during the fourth year.

The key dates are:

Protection	General timing
FDA approval	February 3, 2021
Four-year Paragraph IV filing threshold	February 3, 2025
Five-year NCE approval barrier	February 3, 2026
Patent-controlled entry	Potentially later, depending on enforceable listed patents

The exact regulatory-exclusivity treatment must be read against the current FDA exclusivity record. Orphan-drug exclusivity, if applicable to the relevant indication, could create a separate seven-year barrier, although orphan exclusivity is indication-specific and does not necessarily block every competing product.

Patent exclusivity

Patent protection is likely to determine practical U.S. generic entry more than NCE exclusivity. If core patents remain valid and enforceable into the early or mid-2030s, a generic launch could occur only after patent expiry or through a successful Paragraph IV challenge.

A settlement could permit an earlier launch. No broadly established public settlement has made an earlier Tepmetko generic launch date a standard market assumption.

Which companies are challenging Tepmetko?

No widely reported commercial biosimilar challenge applies to Tepmetko because tepotinib is a chemically synthesized small molecule, not a biologic.

The likely future challengers are generic-drug manufacturers with oncology portfolios and ANDA capabilities. A Paragraph IV challenge would probably focus on:

• Lack of novelty or obviousness for the compound claims.
• Enablement or written-description arguments.
• Invalidity of crystalline-form or formulation claims.
• Non-infringement based on a different manufacturing route or formulation.
• Carve-outs from patented methods of use.

The absence of a publicly prominent Paragraph IV case does not eliminate future risk. It means that the timing of generic entry remains driven by the patent record and future ANDA activity rather than by a disclosed litigation schedule.

How strong is the Tepmetko patent estate?

The estate appears commercially meaningful because it can combine several layers of protection, but its strength cannot be assessed from the existence of multiple patent families alone.

Strength indicators

• A composition-of-matter patent is usually the strongest protection.
• A defined salt or crystalline form can complicate generic development if the approved product depends on that form.
• Formulation patents are weaker if a generic can demonstrate therapeutic equivalence using a different formulation.
• Method-of-use patents are vulnerable to label carve-outs and induced-infringement disputes.
• Manufacturing patents can raise development costs without necessarily preventing market entry.

The key business question is whether a generic can develop a non-infringing tablet while meeting bioequivalence requirements. If the answer is yes, formulation and process patents may delay but not prevent competition.

What manufacturing and intellectual-property barriers affect Tepmetko?

Tepotinib manufacturing may require control of stereochemistry, impurity profiles, solid-state properties, and tablet stability. Generic manufacturers must reproduce the active ingredient and finished dosage form within FDA quality and bioequivalence requirements.

The most important barriers are:

1. Access to a reliable active-pharmaceutical-ingredient supply chain.
2. Control of the approved solid form and hydrate state.
3. Demonstration of bioequivalence under fed conditions.
4. Avoidance of protected manufacturing steps.
5. Development of a permissible product label if method-of-use patents remain active.

These barriers are meaningful but typical for an oral small molecule. They are less formidable than the manufacturing barriers associated with biologics or antibody-drug conjugates.

What generic launch scenarios exist for Tepmetko?

Three scenarios are commercially plausible.

Scenario 1: Patent-protected launch in the early-to-mid-2030s

This is the default scenario if core Orange Book patents survive and no settlement permits earlier entry. Tepmetko would retain branded pricing but face declining volume as generic substitution becomes available.

Scenario 2: Earlier launch after Paragraph IV litigation

A generic applicant could challenge key patents after the four-year NCE period. A successful invalidity or non-infringement outcome could produce entry before nominal patent expiration.

Scenario 3: Settlement-based entry

Merck KGaA and a generic company could agree to an authorized or licensed entry date. The commercial effect would depend on whether the agreement permits an authorized generic, preserves limited exclusivity, or allows multiple generic entrants.

The most important value date is therefore not simply the expiration of the last patent. It is the earliest credible generic-entry date after accounting for litigation, settlement, regulatory review, and supply readiness.

What is Tepmetko’s geographic coverage?

Tepmetko has the broadest commercial relevance in markets with routine comprehensive genomic profiling.

Region	Status and commercial relevance
United States	Major revenue market; FDA-approved targeted treatment
European Union	Conditional authorization; reimbursement varies by country
Japan	Early approval and important MET-targeted market
Other markets	Access depends on national approvals, reimbursement, and diagnostic infrastructure

European uptake is less uniform than U.S. uptake because pricing negotiations and health-technology assessments occur country by country. Japan has a comparatively strong precision-oncology testing environment but a smaller absolute patient pool.

What licensing deals affect Tepmetko?

Tepmetko’s commercial model is primarily an internal Merck KGaA and EMD Serono product rather than a widely disclosed co-commercialization asset. The company has used regional operating structures, regulatory partnerships, and diagnostic relationships to support market access.

No major public licensing transaction has established a separate third-party economic owner of Tepmetko comparable to a traditional royalty-bearing biotech license. The principal commercial dependencies are Merck KGaA’s development, manufacturing, regulatory, and oncology sales infrastructure.

What is the revenue exposure for Merck KGaA?

Tepmetko is strategically useful but unlikely to be a group-level revenue driver on the scale of Merck KGaA’s largest medicines. Its value lies in targeted-oncology growth and portfolio diversification.

Revenue exposure is concentrated in:

• U.S. reimbursement and payer coverage.
• Continued use of broad molecular testing.
• Treatment duration in responders.
• Market share against Tabrecta.
• Confirmation of clinical benefit under accelerated approval.
• Patent durability through the 2030s.

Because Merck KGaA does not consistently publish a separate Tepmetko revenue line, investors should avoid treating total Healthcare segment growth as a direct proxy for Tepmetko performance.[3]

Key Takeaways

• Tepmetko is tepotinib, an oral MET inhibitor for metastatic NSCLC with MET exon 14 skipping alterations.
• Its commercial market is biomarker-defined and likely represents a low-thousands annual U.S. treatment population.
• Tabrecta is the principal direct competitor.
• U.S. approval was granted under the accelerated-approval pathway in February 2021.
• Merck KGaA does not consistently disclose Tepmetko sales separately, limiting precise product-level financial analysis.
• Generic risk is more relevant than biosimilar risk because tepotinib is a small molecule.
• NCE exclusivity began in 2021, but patent protection is likely to control practical generic timing.
• The most important patent questions concern compound, solid-state, formulation, method-of-use, and manufacturing claims.
• Tepmetko’s commercial outlook depends on diagnostic adoption, reimbursement, competitive share, confirmatory regulatory outcomes, and patent durability.

FAQs

Is Tepmetko chemotherapy or targeted therapy?

Tepmetko is targeted therapy. It inhibits MET signaling and is prescribed only when the tumor contains a qualifying MET exon 14 skipping alteration.

Can Tepmetko be used for MET amplification?

The FDA indication is for MET exon 14 skipping alterations in metastatic NSCLC. MET amplification alone is not the same biomarker and does not automatically establish eligibility under the U.S. label.

Which diagnostic tests identify patients for Tepmetko?

Patients can be identified through validated tissue or liquid-biopsy testing platforms authorized or accepted for detecting MET exon 14 skipping alterations. The applicable FDA label and test authorization determine use in the United States.

Does Tepmetko have biosimilar competition?

No. Tepmetko is a chemically synthesized small-molecule tablet. Future competition would arise through generic-drug pathways, including ANDA filings and possible Paragraph IV certifications.

What is the main investment risk for Tepmetko?

The principal risks are the small eligible population, competition from Tabrecta, uneven genomic testing, limited product-level financial disclosure, accelerated-approval obligations, and earlier-than-expected generic entry after patent litigation or settlement.

References

1. U.S. Food and Drug Administration. (2021). TEPMETKO (tepotinib) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214770s000lbl.pdf
2. Paik, P. K., Felip, E., Veillon, R., Sakai, H., Cortot, A. B., Garassino, M. C., Mazieres, J., Viteri, S., Senellart, H., Van Schil, P. E., et al. (2020). Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations. New England Journal of Medicine, 383(10), 931-943. https://doi.org/10.1056/NEJMoa2004407
3. Merck KGaA. (2024). Annual report 2023. https://www.emdgroup.com/en/investors/reports-and-financials.html
4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
5. U.S. Food and Drug Administration. (2021). FDA grants accelerated approval to tepotinib for metastatic non-small cell lung cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tepotinib-metastatic-non-small-cell-lung-cancer

DrugChatter Q&A for TEPMETKO

How does tepmetko compare to tabrecta?