Tucatinib - Generic Drug Details

What are the generic drug 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 one hundred and eighty-seven patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for Tucatinib

International Patents:	187
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	56
Patent Applications:	2,571
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
M.D. Anderson Cancer Center	EARLY_PHASE1
Institut Curie	PHASE2
Eurofins	PHASE2

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

Anatomical Therapeutic Chemical (ATC) Classes for Tucatinib

L01EH	Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	11,207,324
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	9,693,989		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	8,648,087		Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	11,504,370
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	11,666,572

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/005263Tukysa 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
Australia	2018258663	Treatment of HER2 positive cancers
Australia	2022241509	Treatment of HER2 positive cancers
Brazil	112019022280	tratamento de cânceres de her2 positivo
Canada	3060407	TRAITEMENT DES CANCERS POSITIFS A HER2 (TREATMENT OF HER2 POSITIVE CANCERS)
China	111032082	HER2阳性癌症的治疗 (TREATMENT OF HER2 POSITIVE CANCERS)
Eurasian Patent Organization	201992573	ЛЕЧЕНИЕ HER2-ПОЛОЖИТЕЛЬНЫХ ЗЛОКАЧЕСТВЕННЫХ НОВООБРАЗОВАНИЙ
European Patent Office	3615067	TRAITEMENT DES CANCERS POSITIFS À HER2 (TREATMENT OF HER2 POSITIVE CANCERS)

Supplementary Protection Certificates for Tucatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	PA2021516,C1971601	Lithuania		PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601	PA2021516	Lithuania		PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601	C20210018 00331	Estonia		PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021
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	C202130042	Spain		PRODUCT NAME: TUCATINIB, OPCIONALMENTE EN FORMA DE UNA SAL O SOLVATO ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211
1971601	2190026-1	Sweden		PRODUCT NAME: TUCATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NAT. REG. NO/DATE: EU/20/1526 20210212; FIRST REG.: CH 67798 20200507
1971601	132021000000128	Italy		PRODUCT NAME: TUCATINIB OPZIONALMENTE NELLA FORMA DI UN SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(TUKYSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1526, 20210212