TUCATINIB - Generic Drug Details
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What are the generic sources for tucatinib and what is the scope of patent protection?
Tucatinib
is the generic ingredient in one branded drug marketed by Seagen and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tucatinib has two hundred and seventeen patent family members in forty-five countries.
One supplier is listed for this compound.
Summary for TUCATINIB
International Patents: | 217 |
US Patents: | 7 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 47 |
Patent Applications: | 291 |
What excipients (inactive ingredients) are in TUCATINIB? | TUCATINIB excipients list |
DailyMed Link: | TUCATINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TUCATINIB
Generic Entry Date for TUCATINIB*:
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 TUCATINIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
SCRI Development Innovations, LLC | Phase 2 |
Spanish Breast Cancer Research Group | Phase 2 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
---|---|---|---|
Japan | 4828421 | ⤷ Try a Trial | |
European Patent Office | 1971601 | DERIVÉS DE LA N4-PHÉNYL-QUINAZOLINE-4-AMINE ET COMPOSÉS SIMILAIRES EN TANT QUE INHIBITEURS DE LA KINASE TYROSINE ERBB TYPE I POUR LE TRAITEMENT DE MALADIES HYPERPROLIFERATIVES (N4-PHENYL-QUINAZOLINE-4 -AMINE DERIVATIVES AND RELATED COMPOUNDS AS ERBB TYPE I RECEPTOR TYROSINE KINASE INHIBITORS FOR THE TREATMENT OF HYPERPROLIFERATIVE DISEASES) | ⤷ Try a Trial |
Chile | 2004002066 | COMPUESTOS DERIVADOS DE QUINAZOLINA, SUS ENANTIOMEROS, DIASTEREOMEROS, SOLVATOS Y SALES, INHIBIDORES DEL RECEPTOR TIROSINA QUINASA; COMPOSICION FARMACEUTICA; Y SU USO PARA TRATAR ENFERMEDADES HIPERDEGENERATIVAS EN MAMIFEROS, TALES COMO CANCER, INFLAM | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TUCATINIB
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1971601 | CR 2021 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1526 20210212 |
1971601 | 27/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: EU/1/20/1526 (MITTEILUNG) 20210212 |
1971601 | C20210018 00331 | Estonia | ⤷ Try a Trial | 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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