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
*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
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Samsung Medical Center | Phase 2 |
| Institute of Cancer Research, United Kingdom | Phase 1 |
Pharmacology for tepotinib hydrochloride
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Mesenchymal Epithelial Transition Inhibitors P-Glycoprotein Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ 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 | 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 |
|---|---|---|---|
| Japan | 2010532768 | ⤷ Sign Up | |
| Slovenia | 2754660 | ⤷ Sign Up | |
| Japan | 2010532774 | ⤷ Sign Up | |
| South Korea | 101544624 | ⤷ Sign Up | |
| Denmark | 2164843 | ⤷ Sign Up | |
| Argentina | 067505 | DERIVADOS DE PIRIMIDINIL-PIRIDAZINONA | ⤷ Sign Up |
| Cyprus | 1118498 | ⤷ 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 | CA 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 | 301176 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB EN FARMACEUTISCH AANVAARDBARE SOLVATEN EN ZOUTEN DAARVAN; 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 | C202230027 | Spain | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB Y SUS SOLVATOS, SALES, TAUTOMEROS Y ESTEREOISOMEROS FARMACEUTICAMENTE UTILIZABLES DE LOS MISMOS; NATIONAL AUTHORISATION NUMBER: EU/1/21/1596; DATE OF AUTHORISATION: 20220216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1596; DATE OF FIRST AUTHORISATION IN EEA: 20220216 |
| 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 | 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 | C02164843/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021 |
| >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.
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