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Last Updated: January 30, 2023

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

SponsorPhase
Spanish Breast Cancer Research GroupPhase 2
Criterium, Inc.Phase 2
Merck Sharp & Dohme LLCPhase 1

See all tucatinib clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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

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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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Merck
Harvard Business School
Johnson and Johnson
Medtronic

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.