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Last Updated: May 19, 2024

Tucatinib - Generic Drug Details


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What are the generic 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 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

SponsorPhase
M.D. Anderson Cancer CenterPhase 2
SCRI Development Innovations, LLCPhase 2
Spanish Breast Cancer Research GroupPhase 2

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 213411-001 Apr 17, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Eurasian Patent Organization 201992573 ЛЕЧЕНИЕ HER2-ПОЛОЖИТЕЛЬНЫХ ЗЛОКАЧЕСТВЕННЫХ НОВООБРАЗОВАНИЙ ⤷  Try a Trial
Japan 2010270154 METHOD FOR PRODUCING N4-PHENYL-QUINAZOLINE-4-AMINE DERIVATIVE, AND INTERMEDIATE THEREOF ⤷  Try a Trial
Denmark 2827900 ⤷  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 2021C/531 Belgium ⤷  Try a Trial PRODUCT NAME: TUCATINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND 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 122021000042 Germany ⤷  Try a Trial PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211
>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.