TEPOTINIB HYDROCHLORIDE - Generic Drug Details
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What are the generic drug 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-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
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 1/Phase 2 |
Samsung Medical Center | Phase 2 |
Merck Serono GmbH, Germany | 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 | ⤷ 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 | ||
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 TEPOTINIB HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 2164844 | DÉRIVÉS DE PYRIMIDINYLPYRIDAZINONE (PYRIMIDINYL PYRIDAZINONE DERIVATES) | ⤷ Sign Up |
New Zealand | 583186 | PYRIMIDINYL-PYRIDAZINONE DERIVATIVES | ⤷ Sign Up |
Japan | 5426544 | ⤷ Sign Up | |
Slovenia | 2164844 | ⤷ Sign Up | |
Croatia | P20120661 | ⤷ 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 | 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 | 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 |
2164843 | C02164843/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TEPOTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68113 22.06.2021 |
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,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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