Tucatinib - Generic Drug Details
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What are the generic drug sources for tucatinib and what is the scope of freedom to operate?
Tucatinib
is the generic ingredient in one branded drug marketed by Seagen and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tucatinib has one hundred and ninety-four patent family members in forty-one countries.
One supplier is listed for this compound.
Summary for tucatinib
International Patents: | 194 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 54 |
Clinical Trials: | 41 |
Patent Applications: | 337 |
What excipients (inactive ingredients) are in tucatinib? | tucatinib excipients list |
DailyMed Link: | tucatinib at DailyMed |
Recent Clinical Trials for tucatinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Spanish Breast Cancer Research Group | Phase 2 |
Criterium, Inc. | Phase 2 |
Merck Sharp & Dohme LLC | Phase 1 |
Pharmacology for tucatinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors |
US Patents and Regulatory Information for tucatinib
EU/EMA Drug Approvals for tucatinib
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Seagen B.V. | Tukysa | tucatinib | EMEA/H/C/005263 Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑HER2 treatment regimens., |
Authorised | no | no | no | 2021-02-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for tucatinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20082598 | See Plans and Pricing | |
Japan | 2016027062 | 固体分散体 (SOLID DISPERSION) | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2007059257 | See Plans and Pricing | |
South Africa | 200601333 | Quinazoline analogs as receptor tyrosine kinase inhibitors | See Plans and Pricing |
European Patent Office | 2827900 | DISPERSION SOLIDE AMORPHE POUR SON UTILISATION DANS LE TRAITEMENT DU CANCER DU CERVEAU (AMORPHOUS SOLID DISPERSION FOR USE IN THE TREATMENT OF BRAIN CANCER) | See Plans and Pricing |
China | 103664802 | Quinazoline analogs as receptor tyrosine kinase inhibitors | See Plans and Pricing |
South Korea | 101086967 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for tucatinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1971601 | 21C1031 | France | See Plans and Pricing | PRODUCT NAME: TUCATINIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL OU D'UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; REGISTRATION NO/DATE: EU/1/20/1526 20210212 |
1971601 | CA 2021 00025 | Denmark | See Plans and Pricing | PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; NAT. REG. NO/DATE: EU/1/20/1526 20210212; FIRST REG. NO/DATE: CH 67798 20200507 |
1971601 | C 2021 022 | Romania | See Plans and Pricing | PRODUCT NAME: TUCATINIB OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC SAU SOLVAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF NATIONAL AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211 |
1971601 | PA2021516,C1971601 | Lithuania | See Plans and Pricing | PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211 |
1971601 | C01971601/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67798 07.05.2020 |
1971601 | 2021C/531 | Belgium | See Plans and Pricing | PRODUCT NAME: TUCATINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212 |
1971601 | C20210018 00331 | Estonia | See Plans and Pricing | PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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