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Last Updated: June 28, 2022

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-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

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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
Drug patent expirations by year for TEPMETKO
Drug Prices for TEPMETKO

See drug prices for TEPMETKO

DrugPatentWatch® Estimated Generic Entry Opportunity 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.

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrimidinyl pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyridazinone derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pyrimidinyl-pyridazinone derivatives for treating a disease which is influenced by inhibition of met kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING ALTERATIONS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Emd Serono Inc TEPMETKO tepotinib hydrochloride TABLET;ORAL 214096-001 Feb 3, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Patent: 7505
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08274534
Estimated Expiration: See Plans and Pricing

Patent: 08274670
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0813707
Estimated Expiration: See Plans and Pricing

Patent: 0814616
Estimated Expiration: See Plans and Pricing

Canada

Patent: 92867
Estimated Expiration: See Plans and Pricing

Patent: 93600
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08001392
Estimated Expiration: See Plans and Pricing

China

Patent: 1687857
Estimated Expiration: See Plans and Pricing

Patent: 1743241
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70360
Estimated Expiration: See Plans and Pricing

Patent: 70257
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120661
Estimated Expiration: See Plans and Pricing

Patent: 0150031
Estimated Expiration: See Plans and Pricing

Patent: 0170100
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13137
Estimated Expiration: See Plans and Pricing

Patent: 15925
Estimated Expiration: See Plans and Pricing

Patent: 18498
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 64843
Estimated Expiration: See Plans and Pricing

Patent: 64844
Estimated Expiration: See Plans and Pricing

Patent: 54660
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 109953
Estimated Expiration: See Plans and Pricing

Patent: 109957
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6782
Estimated Expiration: See Plans and Pricing

Patent: 7281
Estimated Expiration: See Plans and Pricing

Patent: 1000093
Estimated Expiration: See Plans and Pricing

Patent: 1000094
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 64843
Estimated Expiration: See Plans and Pricing

Patent: 64844
Estimated Expiration: See Plans and Pricing

Patent: 54660
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2007032507
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 42891
Estimated Expiration: See Plans and Pricing

Patent: 45265
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30519
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3091
Estimated Expiration: See Plans and Pricing

Patent: 3094
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26543
Estimated Expiration: See Plans and Pricing

Patent: 26544
Estimated Expiration: See Plans and Pricing

Patent: 10532768
Estimated Expiration: See Plans and Pricing

Patent: 10532774
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 54660
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3727
Estimated Expiration: See Plans and Pricing

Patent: 3477
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3186
Estimated Expiration: See Plans and Pricing

Patent: 3187
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090287
Estimated Expiration: See Plans and Pricing

Poland

Patent: 64843
Estimated Expiration: See Plans and Pricing

Patent: 64844
Estimated Expiration: See Plans and Pricing

Patent: 54660
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 64843
Estimated Expiration: See Plans and Pricing

Patent: 64844
Estimated Expiration: See Plans and Pricing

Patent: 54660
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3739
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 64843
Estimated Expiration: See Plans and Pricing

Patent: 64844
Estimated Expiration: See Plans and Pricing

Patent: 54660
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1001023
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1544624
Estimated Expiration: See Plans and Pricing

Patent: 1553418
Estimated Expiration: See Plans and Pricing

Patent: 100031771
Estimated Expiration: See Plans and Pricing

Patent: 100050504
Estimated Expiration: See Plans and Pricing

Spain

Patent: 88883
Estimated Expiration: See Plans and Pricing

Patent: 26352
Estimated Expiration: See Plans and Pricing

Patent: 14283
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 01768
Estimated Expiration: See Plans and Pricing

Patent: 0906409
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 621
Estimated Expiration: See Plans and Pricing

Patent: 833
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
European Patent Office 2164843 DÉRIVÉS DE PYRIDAZINONE (PYRIDAZINONE DERIVATES) See Plans and Pricing
Cyprus 1115925 See Plans and Pricing
Hong Kong 1142891 PYRIMIDINYL PYRIDAZINONE DERIVATES See Plans and Pricing
Slovenia 2754660 See Plans and Pricing
Germany 102007032507 Pyridazinonderivate See Plans and Pricing
European Patent Office 2754660 Dérivés de pyridazinone (Pyridazinone derivatives) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEPMETKO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2164843 PA2022009 Lithuania See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1596 20220217
2164843 C02164843/01 Switzerland See Plans and Pricing PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
McKinsey
Harvard Business School
Medtronic
Boehringer Ingelheim

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.