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Last Updated: February 3, 2023

Tepotinib hydrochloride - Generic Drug Details


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What are the generic sources for tepotinib hydrochloride and what is the scope of freedom to operate?

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-five patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for tepotinib hydrochloride
International Patents:75
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 5
Clinical Trials: 20
Patent Applications: 47
What excipients (inactive ingredients) are in tepotinib hydrochloride?tepotinib hydrochloride excipients list
DailyMed Link:tepotinib hydrochloride at DailyMed
Recent Clinical Trials for tepotinib hydrochloride

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 1
Hallym University Medical CenterPhase 1/Phase 2
EMD Serono Research & Development Institute, Inc.Phase 1/Phase 2

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 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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for tepotinib hydrochloride

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 C02164843/01 Switzerland See Plans and Pricing PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021
2164843 2022C/519 Belgium See Plans and Pricing PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDARBE SOLVATEN, ZOUTEN, TAUTOMEREN EN STEREOISOMEREN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1596 20220217
2164843 122022000047 Germany See Plans and Pricing PRODUCT NAME: TEPOTINIB SOWIE DIE PHARMAZEUTISCH VERWENDBAREN SOLVATE, SALZE, TAUTOMERE UND STEREOISOMERE 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.