TUCATINIB - Generic Drug Details

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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 seven 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:	7
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity 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
China	103772373	Quinazoline analogs as receptor tyrosine kinase inhibitors	⤷ Sign Up
Japan	2015514075	脳癌の治療	⤷ Sign Up
Slovenia	2765990		⤷ Sign Up
Ukraine	90659	АНАЛОГИ ХИНАЗОЛИНА КАК ИНГИБИТОРЫ РЕЦЕПТОРНЫХ ТИРОЗИНКИНАЗ;АНАЛОГИ ХІНАЗОЛІНУ ЯК ІНГІБІТОРИ РЕЦЕПТОРНИХ ТИРОЗИНКІНАЗ (QUINAZOLINE ANALOGS AS RECEPTOR TYROSINE KINASE INHIBITORS)	⤷ Sign Up
Finland	C20210022		⤷ Sign Up
>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	301113	Netherlands	⤷ Sign Up	PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
1971601	C202130042	Spain	⤷ Sign Up	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	2021C/531	Belgium	⤷ Sign Up	PRODUCT NAME: TUCATINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
1971601	PA2021516	Lithuania	⤷ Sign Up	PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601	122021000042	Germany	⤷ Sign Up	PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.