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 seven patents protecting this drug.

This drug has one hundred and eighty-two 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 was eligible for patent challenges on April 17, 2024.

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:	182
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	17
Patent Applications:	108
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

Constraining patent/regulatory exclusivity:

9,457,093

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
RemeGen Co., Ltd.	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1
Jonathan Riess	Phase 1

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

US Patents and Regulatory Information for TUKYSA

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

This potential generic entry date is based on patent 9,457,093.

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

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	11,504,370
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	8,648,087		Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No	9,457,093		Y
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	8,648,087		Y	Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes	11,504,370
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes

Expired US Patents for TUKYSA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020	7,452,895
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020	7,452,895

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	114886853	ErbB2(HER2)抑制剂的固态分散体 (Solid dispersions of ErbB2 (HER2) inhibitors)
Colombia	7071139	Tratamiento contra el cáncer cerebral
Israel	269205	דיספרסיה אמורפית מוצקה לשימוש בטיפול בחולה בעל סרטן ריאות המגיב חיובית ל- erbb2 (Amorphous solid dispersion for use in treating a patient having erbb2 positive breast cancer)
New Zealand	545459	Quinazoline analogs as receptor tyrosine kinase inhibitors
Russian Federation	2592703	ИНГИБИТОРЫ ТИПА ErbB (INHIBITORS OF TYPE ErbB INHIBITORS)
Russian Federation	2018107710	ТВЕРДАЯ ДИСПЕРСИЯ
Spain	2399427

Supplementary Protection Certificates for TUKYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2765990	2021029	Norway		PRODUCT NAME: TUKATINIB; NAT. REG. NO/DATE: EU/1/20/1526 20210225; FIRST REG. NO/DATE: 67798 20210212
1971601	2021C/531	Belgium		PRODUCT NAME: TUCATINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
1971601	21C1031	France		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	27/2021	Austria		PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: EU/1/20/1526 (MITTEILUNG) 20210212
1971601	301113	Netherlands		PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
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	LUC00217	Luxembourg		PRODUCT NAME: TUCATINIB EVENTUELLEMENT SOUS FORME D'UN SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212

Market Dynamics and Financial Trajectory for TUKYSA

Introduction to TUKYSA

TUKYSA, also known as tucatinib, is a tyrosine kinase inhibitor developed by Seagen Inc. It is primarily used in the treatment of HER2-positive breast cancer, particularly in patients with brain metastases. Here, we will delve into the market dynamics and financial trajectory of TUKYSA.

Mechanism of Action and Clinical Use

TUKYSA works by inhibiting the HER2 protein, which is often overexpressed in certain types of breast cancer. This inhibition helps in slowing down or stopping the growth of cancer cells. The drug has shown significant efficacy in combination with other therapies, such as trastuzumab and capecitabine, in treating HER2-positive breast cancer, including cases with brain metastases[3].

Regulatory Milestones

TUKYSA has achieved several regulatory milestones that have significantly impacted its market presence. It was approved by the FDA in April 2020 for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. Additionally, it received approval in the European Union in February 2021, which has driven its sales growth in European markets[2].

Market Forecast and Growth

The market forecast for TUKYSA is promising, driven by several factors:

• Increased Sales: TUKYSA has seen steady growth in sales, particularly in European markets following its EU approval. In the second quarter of 2022, TUKYSA sales were driven by increased penetration in European markets and continued use in the U.S.[2].
• Clinical Trials: Positive outcomes from clinical trials, such as the Phase 3 HER2CLIMB-02 trial, where TUKYSA in combination with ado-trastuzumab emtansine (Kadcyla) met its primary endpoint of progression-free survival (PFS), are expected to enhance its market position. Analysts predict that these results could potentially double TUKYSA's current market[4].
• Market Expansion: The drug is being evaluated in various other indications, including HER2-positive breast, colorectal, and gastric cancers, as well as HER2 mutant tumors. This broad clinical development program is designed to maximize TUKYSA's potential and expand its market reach[3].

Competitive Landscape

TUKYSA operates in a competitive landscape with other approved products for HER2-positive breast cancer:

• Competing Therapies: Other approved products, such as Enhertu (trastuzumab deruxtecan), provide competition to TUKYSA. However, the combination approach of TUKYSA with Kadcyla changes the dynamic from competitors to collaborators, potentially strengthening TUKYSA's role in the treatment sequence[4].
• Emerging Therapies: The launch of late-stage emerging therapies in the near future will also impact the market. However, TUKYSA's unique positioning and clinical trial outcomes are expected to maintain its competitive edge[1].

Financial Performance

The financial performance of TUKYSA is closely tied to Seagen Inc.'s overall financial health:

• Revenue Growth: TUKYSA has contributed significantly to Seagen's revenue growth. In the third quarter of 2023, Seagen reported total revenues of $649 million, driven primarily by growth in net product sales, including TUKYSA[5].
• Net Product Sales: The net product sales of TUKYSA have shown consistent growth. For instance, in the first quarter of 2021, TUKYSA sales were $70 million, a 14% increase over the previous quarter[3].
• Costs and Expenses: The cost of sales for TUKYSA includes third-party royalties and amortization of acquired in-process technology costs. Despite these costs, the gross profit from TUKYSA sales has been substantial, contributing to Seagen's financial strength[5].

Strategic Priorities and Future Outlook

Seagen Inc. has outlined several strategic priorities that will drive the continued growth and innovation of TUKYSA:

• Maximizing Global Potential: Seagen is focused on maximizing the global potential of TUKYSA through robust clinical development programs and strategic marketing efforts[3].
• Advancing Late-Stage Programs: The company is advancing its late-stage programs, including new product approvals, which will further expand its portfolio and enhance TUKYSA's market position[3].
• Collaborations and Partnerships: Seagen's collaborations and partnerships, such as those with other pharmaceutical companies, are crucial for the development and commercialization of TUKYSA. These partnerships help in leveraging technology and resources to enhance the drug's market reach[3].

Key Takeaways

• Regulatory Approvals: TUKYSA has received significant regulatory approvals, including FDA and EU approvals, which have driven its market growth.
• Clinical Trial Outcomes: Positive outcomes from clinical trials, such as the HER2CLIMB-02 trial, are expected to enhance TUKYSA's market position.
• Market Expansion: TUKYSA is being evaluated in various other indications, which will expand its market reach.
• Financial Performance: TUKYSA has contributed significantly to Seagen's revenue growth, with consistent increases in net product sales.
• Competitive Edge: TUKYSA's unique positioning and combination approach with other therapies maintain its competitive edge in the market.

FAQs

What is TUKYSA used for?

TUKYSA is used in the treatment of HER2-positive breast cancer, particularly in patients with brain metastases.

What are the key regulatory milestones for TUKYSA?

TUKYSA was approved by the FDA in April 2020 and received EU approval in February 2021.

How has TUKYSA performed financially?

TUKYSA has contributed significantly to Seagen's revenue growth, with consistent increases in net product sales, particularly in European markets.

What are the competitive dynamics for TUKYSA?

TUKYSA competes with other approved products like Enhertu but maintains a competitive edge through its unique positioning and combination approaches.

What are the future outlook and strategic priorities for TUKYSA?

Seagen is focused on maximizing TUKYSA's global potential through clinical development programs, advancing late-stage programs, and leveraging collaborations and partnerships.

Sources

1. ASDReports: "Tukysa - Drug Insight and Market Forecast - 2030" report by DelveInsight.
2. BusinessWire: Seagen Reports Second Quarter 2022 Financial Results.
3. Seagen Inc.: Q1 2021 Earnings Call Transcript.
4. Business Insider: Analyst Says The Update Might Double Tukysa's Current Market.
5. BusinessWire: Seagen Third Quarter 2023 Financial Results Reflect Strong Product Sales Growth and Significant Portfolio and Pipeline Progress.