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-one patent family members in thirty-two 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:	71
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	141
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 Generic Entry Opportunity 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

Anatomical Therapeutic Chemical (ATC) Classes for TEPMETKO

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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.

Patents protecting TEPMETKO

FDA Regulatory Exclusivity protecting TEPMETKO

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	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
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes			Y	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

Germany

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

New Zealand

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
South Africa	201001023	PYRIMIDINYL PYRIDAZINONE DERIVATES
European Patent Office	2164843	DÉRIVÉS DE PYRIDAZINONE (PYRIDAZINONE DERIVATES)
Cyprus	1115925
Hong Kong	1142891	PYRIMIDINYL PYRIDAZINONE DERIVATES
Slovenia	2754660
Germany	102007032507	Pyridazinonderivate
European Patent Office	2754660	Dérivés de pyridazinone (Pyridazinone derivatives)

Supplementary Protection Certificates for TEPMETKO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	301176	Netherlands		PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843	C02164843/01	Switzerland		PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021