Tucatinib - Generic Drug Details

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

See all tucatinib clinical trials

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

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

International Patents for tucatinib

Country	Patent Number	Title	Estimated Expiration
Norway	20082598
Japan	2016027062	固体分散体 (SOLID DISPERSION)
World Intellectual Property Organization (WIPO)	2007059257
South Africa	200601333	Quinazoline analogs as receptor tyrosine kinase inhibitors
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)
China	103664802	Quinazoline analogs as receptor tyrosine kinase inhibitors
South Korea	101086967

Supplementary Protection Certificates for tucatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	21C1031	France		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		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		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		PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601	C01971601/01	Switzerland		PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67798 07.05.2020
1971601	2021C/531	Belgium		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		PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021