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Last Updated: April 16, 2024

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 seventeen patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for TUCATINIB

International Patents:	217
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	47
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
M.D. Anderson Cancer Center	Phase 2
SCRI Development Innovations, LLC	Phase 2
Spanish Breast Cancer Research Group	Phase 2

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

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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
World Intellectual Property Organization (WIPO)	2005016346		⤷ Try a Trial
Russian Federation	2014119283	ТВЕРДАЯ ДИСПЕРСИЯ	⤷ Try a Trial
South Korea	102160462		⤷ Try a Trial
>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	⤷ Try a Trial	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	301113	Netherlands	⤷ Try a Trial	PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
1971601	LUC00217	Luxembourg	⤷ Try a Trial	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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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.

Summary for TUCATINIB

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TUCATINIB

Recent Clinical Trials for TUCATINIB

Pharmacology for TUCATINIB

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUCATINIB