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Last Updated: November 11, 2024

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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.

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

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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
Drug patent expirations by year for TEPMETKO
Drug Prices for TEPMETKO

See drug prices for TEPMETKO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TEPMETKO
Generic Entry Date for TEPMETKO*:
Constraining patent/regulatory exclusivity:
NDA:
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

US Patents and Regulatory Information for TEPMETKO

TEPMETKO is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEPMETKO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB

Pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, HAVING A MET KINASE ALTERATION(S) BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB

Pyrimidinyl pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyridazinone derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), OR STABILIZING OR IMPROVING SYMPTOMS ASSOCIATED WITH HAVING A SOLID TUMOR, INCLUDING LUNG CANCER, WITH A MET ALTERATION(S), BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB

FDA Regulatory Exclusivity protecting TEPMETKO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 6543
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Patent: 7505
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08274534
Patent: Pyrimidinyl pyridazinone derivates
Estimated Expiration: ⤷  Sign Up

Patent: 08274670
Patent: Pyridazinone derivates
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0813707
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Patent: 0814616
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 92867
Patent: DÉRIVÉS DE PYRIDAZINONE (Pyrimidinyl-pyridazinone derivatives.)
Estimated Expiration: ⤷  Sign Up

Patent: 93600
Patent: DERIVES DE PYRIDAZINONE (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08001392
Patent: Compuestos derivados de piridazinona, con actividad moduladora de quinasas; procedimiento de preparacion de dichos compuestos; composicion farmaceutica que comprende a dichos compuestos; kit farmaceutico; y uso para tratar un tumor solido.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1687857
Patent: Pyridazinone derivates
Estimated Expiration: ⤷  Sign Up

Patent: 1743241
Patent: Pyridazinone derivates
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 70360
Patent: DERIVADOS DE PIRIMIDINIL - PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Patent: 70257
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0120661
Estimated Expiration: ⤷  Sign Up

Patent: 0150031
Estimated Expiration: ⤷  Sign Up

Patent: 0170100
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 13137
Estimated Expiration: ⤷  Sign Up

Patent: 15925
Estimated Expiration: ⤷  Sign Up

Patent: 18498
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 64843
Estimated Expiration: ⤷  Sign Up

Patent: 64844
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 109953
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Patent: 109957
Patent: DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA.
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 6782
Patent: ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Patent: 7281
Patent: ПРОИЗВОДНЫЕ ПИРИМИДИНИЛПИРИДАЗИНОНА (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Patent: 1000093
Patent: ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА
Estimated Expiration: ⤷  Sign Up

Patent: 1000094
Patent: ПРОИЗВОДНЫЕ ПИРИМИДИНИЛ-ПИРИДАЗИНОНА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 64843
Patent: DÉRIVÉS DE PYRIDAZINONE (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Patent: 64844
Patent: DÉRIVÉS DE PYRIMIDINYLPYRIDAZINONE (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Patent: Dérivés de pyridazinone (Pyridazinone derivatives)
Estimated Expiration: ⤷  Sign Up

France

Patent: C1024
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2007032507
Patent: Pyridazinonderivate
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 42891
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷  Sign Up

Patent: 45265
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 30519
Estimated Expiration: ⤷  Sign Up

Patent: 200024
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3091
Patent: נגזרות פירידאזינון (Pyridazinone derivatives)
Estimated Expiration: ⤷  Sign Up

Patent: 3094
Patent: נגזרות פירימידיניל-פירידאזינון (Pyrimidinyl-pyridazinone derivatives)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 26543
Estimated Expiration: ⤷  Sign Up

Patent: 26544
Estimated Expiration: ⤷  Sign Up

Patent: 10532768
Estimated Expiration: ⤷  Sign Up

Patent: 10532774
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 2022009
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3727
Patent: PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Patent: 3477
Patent: PYRIMIDINYL-PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 1176
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3186
Patent: PYRIMIDINYL-PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Patent: 3187
Patent: PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 22015
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 090287
Patent: DERIVADOS DE PIRIDAZINONA
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 64843
Estimated Expiration: ⤷  Sign Up

Patent: 64844
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 64843
Estimated Expiration: ⤷  Sign Up

Patent: 64844
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3739
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 64843
Estimated Expiration: ⤷  Sign Up

Patent: 64844
Estimated Expiration: ⤷  Sign Up

Patent: 54660
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1001023
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1544624
Estimated Expiration: ⤷  Sign Up

Patent: 1553418
Estimated Expiration: ⤷  Sign Up

Patent: 100031771
Patent: PYRIMIDINYL PYRIDAZINONE DERIVATIVES
Estimated Expiration: ⤷  Sign Up

Patent: 100050504
Patent: PYRIDAZINONE DERIVATES
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 88883
Estimated Expiration: ⤷  Sign Up

Patent: 26352
Estimated Expiration: ⤷  Sign Up

Patent: 14283
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 01768
Estimated Expiration: ⤷  Sign Up

Patent: 0906409
Patent: Pyridazinone derivatives
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 621
Patent: ПОХІДНІ ПІРИДАЗИНОНУ[ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА (PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

Patent: 833
Patent: ПОХІДНІ ПІРИМІДИНІЛ-ПІРИДАЗИНОНУ[ПРОИЗВОДНЫЕ ПИРИМИДИНИЛ-ПИРИДАЗИНОНА (PYRIMIDINYL PYRIDAZINONE DERIVATES)
Estimated Expiration: ⤷  Sign Up

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
Brazil PI0814616 DERIVADOS DE PIRIDAZINONA ⤷  Sign Up
France 22C1024 ⤷  Sign Up
Slovenia 2164844 ⤷  Sign Up
Canada 2692867 DÉRIVÉS DE PYRIDAZINONE (Pyrimidinyl-pyridazinone derivatives.) ⤷  Sign Up
Taiwan 200906409 Pyridazinone derivatives ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEPMETKO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2164843 22C1024 France ⤷  Sign Up PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843 CR 2022 00021 Denmark ⤷  Sign Up PRODUCT NAME: TEPOTINIB OG FARMACEUTISK ANVENDELIGE SOLVATER, SALTE, TAUTOMERER OG STEREOISOMERER DERAF; REG. NO/DATE: EU 1/21/1596 20220217
2164843 PA2022009 Lithuania ⤷  Sign Up PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843 PA2022009,C2164843 Lithuania ⤷  Sign Up PRODUCT NAME: TEPOTINIBAS IR FARMACINIU POZIURIU TINKAMI NAUDOTI JO SOLVATAI, DRUSKOS, TAUTOMERAI IR STEREOIZOMERAI ; REGISTRATION NO/DATE: EU/1/21/1596 20220216
2164843 122022000047 Germany ⤷  Sign Up PRODUCT NAME: TEPOTINIB SOWIE DIE PHARMAZEUTISCH VERWENDBAREN SOLVATE, SALZE UND TAUTOMERE DAVON, EINSCHL. DEREN MISCHUNGEN IN ALLEN VERHAELTNISSEN; REGISTRATION NO/DATE: EU/1/21/1596 20220216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.