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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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tucatinib has one hundred and thirty-three patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for tucatinib

International Patents:	133
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	22
Patent Applications:	117
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
UNICANCER	Phase 2
ARCAGY/ GINECO GROUP	Phase 2
Seagen Inc.	Phase 2

See all tucatinib clinical trials

Pharmacology for tucatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2C8 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

International Patents for tucatinib

Country	Patent Number	Estimated Expiration
Taiwan	I722189
Japan	2007502295
Australia	2019200243

Supplementary Protection Certificates for tucatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122021000042	Germany		PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211