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 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
Jonathan Riess	Phase 1
National Cancer Institute (NCI)	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	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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			⤷ 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
Israel	239149	מעכבים ל-erbb (Erbb inhibitors)	⤷ Sign Up
Russian Federation	2350605	АНАЛОГИ ХИНАЗОЛИНА В КАЧЕСТВЕ ИНГИБИТОРОВ РЕЦЕПТОРНЫХ ТИРОЗИНКИНАЗ (ANALOGUES OF QUINAZOLINE AS INHIBITORS OF RECEPTOR TYROSINE KINASES)	⤷ Sign Up
Germany	602006009968		⤷ 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	27/2021	Austria	⤷ Sign Up	PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: EU/1/20/1526 (MITTEILUNG) 20210212
1971601	C 2021 022	Romania	⤷ Sign Up	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	LUC00217	Luxembourg	⤷ Sign Up	PRODUCT NAME: TUCATINIB EVENTUELLEMENT SOUS FORME D'UN SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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