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Last Updated: December 2, 2024

Tepotinib hydrochloride - Generic Drug Details


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What are the generic sources for tepotinib hydrochloride and what is the scope of patent protection?

Tepotinib hydrochloride is the generic ingredient in one branded drug marketed by Emd Serono Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tepotinib hydrochloride has seventy-six patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for tepotinib hydrochloride
International Patents:76
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 8
Clinical Trials: 23
Patent Applications: 47
What excipients (inactive ingredients) are in tepotinib hydrochloride?tepotinib hydrochloride excipients list
DailyMed Link:tepotinib hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tepotinib hydrochloride
Generic Entry Date for tepotinib hydrochloride*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for tepotinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
Samsung Medical CenterPhase 2
Merck Sharp & Dohme LLCPhase 1

See all tepotinib hydrochloride clinical trials

Pharmacology for tepotinib hydrochloride

US Patents and Regulatory Information for tepotinib hydrochloride

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 Y 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
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
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 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
>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 tepotinib hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 101544624 ⤷  Sign Up
Denmark 2754660 ⤷  Sign Up
Singapore 183739 PYRIDAZINONE DERIVATES ⤷  Sign Up
Japan 2010532774 ⤷  Sign Up
Australia 2008274670 Pyridazinone derivates ⤷  Sign Up
Portugal 2164844 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009006959 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tepotinib hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2164843 LUC00264 Luxembourg ⤷  Sign Up PRODUCT NAME: TEPOTINIB ET SES SOLVATES, SELS, TAUTOMERES ET STEREOISOMERES PHARMACEUTIQUEMENT UTILISABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1596 20220217
2164843 2290029-4 Sweden ⤷  Sign Up PRODUCT NAME: TEPOTINIB AND PHARMACEUTICALLY USABLE SOLVATES, SALTS, AND TAUTOMERS THEROF; REG. NO/DATE: EU/1/21/1596 20220217
2164843 C02164843/01 Switzerland ⤷  Sign Up PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
2164843 28/2022 Austria ⤷  Sign Up PRODUCT NAME: TEPOTINIB UND PHARMAZEUTISCH VERWENDBARE SOLVATE, SALZE, TAUTOMERE UND STEREOISOMERE DAVON; REGISTRATION NO/DATE: EU/1/21/1596 (MITTEILUNG) 20220217
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 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
>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.