Tucatinib - Generic Drug Details

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 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:	56
Clinical Trials:	44
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
M.D. Anderson Cancer Center	Phase 2
Spanish Breast Cancer Research Group	Phase 2
Zhongnan Hospital	Phase 4

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

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
Japan	4828421
Singapore	11201401459Y	SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Israel	261659	טיפול בסרטן המוח (Treatment of brain cancer)
Cyprus	1119837
Serbia	56608	ČVRSTA DISPERZIJA (SOLID DISPERSION)
Israel	232103	דיספרסיה מוצקה המכילה 4n-)4-([4.2.1]טריאזולו[a5,1]פירידין-7-אילאוקסי-3-מתילפניל)-n6 - (4,4-דימתיל-5,4-דיהידרוקסואוקסאזול-2-איל)קיוונאזולין-6,4-דיאמין ופולימר מבדר, תהליך להכנתה ותכשיר רוקחות המכיל אותה (Solid dispersions of a erb2 (her2) inhibitor)

Supplementary Protection Certificates for tucatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	122021000042	Germany		PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211
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	301113	Netherlands		PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
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