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

Tucatinib has two hundred and eighteen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for tucatinib

International Patents:	218
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	52
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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,457,093 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

Sponsor	Phase
RemeGen Co., Ltd.	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1
Jonathan Riess	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

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

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Glossary

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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	11,504,370	⤷ Subscribe				⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	12,048,698	⤷ Subscribe				⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	8,648,087	⤷ Subscribe	Y	Y		⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	11,504,370	⤷ Subscribe				⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for tucatinib

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020	7,452,895	⤷ Subscribe
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020	7,452,895	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for tucatinib

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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

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2014119283	ТВЕРДАЯ ДИСПЕРСИЯ	⤷ Subscribe
South Korea	102490961		⤷ Subscribe
Japan	7404485		⤷ Subscribe
Norway	20061171		⤷ Subscribe
Denmark	2765990		⤷ Subscribe
Australia	2019200243	SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tucatinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	21C1031	France	⤷ Subscribe	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	C 2021 022	Romania	⤷ Subscribe	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	C202130042	Spain	⤷ Subscribe	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	C20210018 00331	Estonia	⤷ Subscribe	PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021
1971601	C01971601/01	Switzerland	⤷ Subscribe	PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67798 07.05.2020
1971601	PA2021516,C1971601	Lithuania	⤷ Subscribe	PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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