TUKYSA Drug Patent Profile

Which patents cover Tukysa, and what generic alternatives are available?

Tukysa is a drug marketed by Seagen and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and nine patent family members in forty-four countries.

The generic ingredient in TUKYSA is tucatinib. One supplier is listed for this compound. Additional details are available on the tucatinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Tukysa

Tukysa will be eligible for patent challenges on April 17, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TUKYSA

International Patents:	209
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	13
Patent Applications:	124
Drug Prices:	Drug price information for TUKYSA
What excipients (inactive ingredients) are in TUKYSA?	TUKYSA excipients list
DailyMed Link:	TUKYSA at DailyMed

See drug prices for TUKYSA

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

NDA:

213411

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 TUKYSA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
SCRI Development Innovations, LLC	Phase 2
Spanish Breast Cancer Research Group	Phase 2
Criterium, Inc.	Phase 2

See all TUKYSA clinical trials

Pharmacology for TUKYSA

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 TUKYSA

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 TUKYSA

TUKYSA is protected by six US patents and four FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TUKYSA

FDA Regulatory Exclusivity protecting TUKYSA

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
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

EU/EMA Drug Approvals for TUKYSA

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

International Patents for TUKYSA

When does loss-of-exclusivity occur for TUKYSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TUKYSA around the world.

Country	Patent Number	Title	Estimated Expiration
China	109223791	脑癌的治疗 (Treatment of brain cancer)
Japan	2010270154	METHOD FOR PRODUCING N4-PHENYL-QUINAZOLINE-4-AMINE DERIVATIVE, AND INTERMEDIATE THEREOF
China	114886853	ErbB2(HER2)抑制剂的固态分散体 (Solid dispersions of ErbB2 (HER2) inhibitors)

Supplementary Protection Certificates for TUKYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	C202130042	Spain		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	C 2021 022	Romania		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	C20210018 00331	Estonia		PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021