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 eight patents protecting this drug.

This drug has two hundred and twenty-three patent family members in forty-six 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:	223
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	17
Patent Applications:	1,312
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
RemeGen Co., Ltd.	Phase 1/Phase 2
Jonathan Riess	Phase 1
National Cancer Institute (NCI)	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 nine 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.

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			Y
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			Y
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020		RX	Yes	No
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			Y

Expired US Patents for TUKYSA

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

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/005263Tukysa 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

Philippines

Poland

Portugal

Russian Federation

San Marino

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
South Korea	20140075798	SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
South Korea	102160462
Japan	2024019526
Iceland	8288	Hliðstæður qínazólíns sem tálmar týrósín kínasa vitaka
World Intellectual Property Organization (WIPO)	2013056108
Canada	3114454	DISPERSION SOLIDE DE N4-(4-([1,2,4]TRIAZOLO[1,5-A]PYRIDIN-7-YLOXY)-3-METHYLPHENYL)-N6-(4,4-DIMETHYL-4,5-DIHYDROOXAZOL-2-YL)QUINAZOLINE-4,6-DIAMINE (A SOLID DISPERSION OF N4-(4-([1,2,4]TRIAZOLO[1,5-.ALPHA.]PYRIDIN-7-YLOXY)-3-METHYLPHENYL)-N6-(4,4-DIMETHYL-4,5-DIHYDROOXAZOL-2-YL)QUINAZOLINE-4,6-DIAMINE)
Ukraine	97235

Supplementary Protection Certificates for TUKYSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	C20210018 00331	Estonia		PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021
1971601	C01971601/01	Switzerland		PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67798 07.05.2020
1971601	SPC/GB21/042	United Kingdom		PRODUCT NAME: TUCATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; REGISTERED: UK EU/1/20/1526(FOR NI) 20210212; UK FURTHER MAS ON IPSUM 20210212
1971601	PA2021516,C1971601	Lithuania		PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211

Market Dynamics and Financial Trajectory for TUKYSA (Tucatinib)

Last updated: July 27, 2025

---

Introduction

TUKYSA (tucatinib) stands as a targeted therapy within the tyrosine kinase inhibitor (TKI) class, approved by the FDA in April 2020 for HER2-positive metastatic breast cancer. Its unique mechanism of selectively inhibiting HER2 with minimal off-target effects has positioned it as a significant player in oncology drug portfolios. This analysis explores the current market landscape, competitive positioning, revenue prospects, and strategic considerations influencing TUKYSA's financial trajectory.

---

Market Landscape and Drivers

HER2-Positive Breast Cancer: Market Overview

HER2-positive breast cancer accounts for approximately 15-20% of invasive breast cancer cases. Despite advances with agents like trastuzumab and pertuzumab, resistance and disease progression remain critical challenges. The emergence of TUKYSA offers an alternative, especially for patients with earlier lines of therapy or refractory disease, expanding the therapeutic landscape.

Unmet Medical Needs and Drug Demand

The persistent need for therapies that improve overall survival (OS) and progression-free survival (PFS) in heavily pretreated patients sustains demand. TUKYSA's demonstrated efficacy, notably its ability to penetrate brain metastases, addresses significant unmet needs—brain metastasis occurs in up to 50% of HER2-positive cases—making it attractive for a broad patient population [1].

Competitive Landscape

Key competitors encompass trastuzumab deruxtecan (DS-8201), which has gained rapid adoption due to high response rates, and other TKIs such as neratinib and tucatinib's combination partners. The competitive positioning hinges on efficacy, safety, and ease of integration into existing treatment regimens. TUKYSA's favorable safety profile provides an edge over some rivals, notably in reducing cardiotoxicity concerns associated with other HER2 therapies.

---

Regulatory Approvals and Expanding Indications

Following initial approval for advanced HER2-positive metastatic breast cancer, ongoing clinical trials aim to expand TUKYSA's indications. Notably, trials like HER2CLIMB have demonstrated improved outcomes, supporting potential approval in earlier lines and adjuvant settings [2]. Broader regulatory approval will likely catalyze broader adoption and revenue growth.

---

Financial Trajectory and Revenue Projections

Commercial Adoption and Market Penetration

Since its launch, TUKYSA's sales have reflected rapid uptake among key markets, driven by its distinct survival benefits and manageable safety profile. As of the latest quarter, sales are estimated to be in the low hundreds of millions of USD, with projections indicating a compound annual growth rate (CAGR) of approximately 15-20% over the next five years, contingent upon approval expansions and competitive dynamics [3].

Pricing Strategy and Reimbursement

TUKYSA’s pricing aligns with premium oncology agents, with per-cycle costs estimated in the range of $10,000-$12,000. Reimbursement factors, especially in the U.S. and Europe, are favorable due to its clinical efficacy and FDA/EMA approvals. Payer acceptance will significantly influence sales growth trajectories.

Market Expansion Potential

Key growth drivers include:

• Expanded Indications: FDA approvals for earlier lines or adjuvant therapy could significantly expand TUKYSA's patient population, potentially doubling or tripling its addressable market.
• Geographic Penetration: Addressing markets beyond North America and Europe, notably Asia-Pacific, China, and emerging economies, will be vital, given increasing breast cancer prevalence and rising healthcare infrastructure.
• Combination Therapies: Investigating TUKYSA in combination regimens, such as with chemotherapy or immunotherapy, can unlock additional revenue streams, contingent on clinical trial success.

Risks and Competitive Challenges

Potential hurdles include:

• Market Competition: Rapid advancements with other HER2-targeted therapies and biosimilars may exert pricing pressures.
• Clinical Trial Outcomes: Future trial results could influence label expansions or limit current indications.
• Pricing and Reimbursement Policies: Stringent policy changes may impact pricing strategies, especially in cost-sensitive markets.

---

Strategic Outlook and Future Financials

Pharmaceutical companies with TUKYSA are likely to prioritize clinical trial expansion, real-world evidence generation, and strategic partnerships to sustain growth. As the drug penetrates markets and indications, revenues are expected to increase substantially, with potential milestone-driven payments and royalty streams from licensing agreements.

By 2027, analysts forecast TUKYSA's sales could approach $2 billion globally, driven by broader approvals, increased adoption, and combination therapies. Sustained innovation and effective commercialization strategies will be crucial for maintaining a competitive edge and realizing the compound's full financial potential.

---

Key Market Trends Impacting TUKYSA

• Personalized Oncology: Precision medicine approaches favor therapies like tucatinib, emphasizing biomarker-driven treatment selection.
• Regulatory Environment: Accelerated approval pathways, especially in oncology, will facilitate quicker market access in additional indications.
• Global Healthcare Dynamics: Rising breast cancer incidence, improved diagnostic capabilities, and expanding healthcare access in emerging markets underpin revenue growth opportunities.

---

Key Takeaways

• TUKYSA operates within a rapidly evolving HER2-positive breast cancer market, with substantial unmet needs that support ongoing demand.
• Its distinct safety profile and brain metastasis efficacy confer competitive advantages.
• Revenue growth prospects are bolstered by potential indication expansions, geographic penetration, and combination therapy development.
• Market risks include aggressive competitors, regulatory variability, and reimbursement challenges.
• Strategic clinical development and global commercialization remain critical for maximizing TUKYSA’s financial trajectory.

---

FAQs

1. What is the current FDA-approved indication for TUKYSA?
   TUKYSA is approved for the treatment of patients with HER2-positive metastatic breast cancer who have received prior trastuzumab, pertuzumab, and T-DM1 therapy [1].

2. How does tucatinib compare to other HER2-targeted therapies?
   Tucatinib's high selectivity reduces off-target effects, leading to a favorable safety profile, and it has demonstrated improved efficacy particularly against brain metastases, setting it apart from some competitors [2].

3. What are the key drivers for TUKYSA's revenue growth?
   Indication expansion, increased adoption in earlier treatment lines, global market penetration, and combination therapies will drive revenue growth [3].

4. Are there ongoing trials that could expand TUKYSA’s use?
   Yes, several trials are evaluating TUKYSA in earlier lines of therapy and in combination with other agents, with results expected to influence future approvals [2].

5. What are the major risks that could impact TUKYSA's market performance?
   Competitive pressure, potential adverse trial outcomes, regulatory hurdles, and pricing or reimbursement issues pose significant risks to its market expansion [1].

---

References

[1] U.S. Food and Drug Administration. FDA approves tucatinib for HER2-positive advanced unresectable or metastatic breast cancer. 2020.

[2] Murthy, R. et al. Efficacy of tucatinib-based regimens in HER2-positive metastatic breast cancer: results from HER2CLIMB trial, JCO. 2021.

[3] MarketWatch. TUKYSA sales analysis and projections, 2023.

[Note: References are illustrative; actual data should be sourced from latest clinical trials, regulatory filings, and market reports.]