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 four patents protecting this drug.

This drug has one hundred and thirty-seven patent family members in thirty-eight 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:	137
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	10
Patent Applications:	118
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 Generic Entry Opportunity 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
Jonsson Comprehensive Cancer Center	Phase 1/Phase 2
Sarah Sammons, MD	Phase 2
Criterium, Inc.	Phase 1/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 four US patents and two 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			Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes			Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No			Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes

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
Croatia	P20171578
Japan	2007502295
Brazil	122020010643	Dispersão sólida, composições farmacêuticas compreendendo a referida dispersão, usos das composições farmacêuticas e processo de preparação de uma dispersão sólida
Cyprus	1119837

Supplementary Protection Certificates for TUKYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	301113	Netherlands		PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
1971601	LUC00217	Luxembourg		PRODUCT NAME: TUCATINIB EVENTUELLEMENT SOUS FORME D'UN SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
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	122021000042	Germany		PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211