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-four 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:	224
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
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 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

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
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	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	20060064630	QUINAZOLINE ANALOGS AS RECEPTOR TYROSINE KINASE INHIBITORS
Australia	2017272232
Russian Federation	2350605	АНАЛОГИ ХИНАЗОЛИНА В КАЧЕСТВЕ ИНГИБИТОРОВ РЕЦЕПТОРНЫХ ТИРОЗИНКИНАЗ (ANALOGUES OF QUINAZOLINE AS INHIBITORS OF RECEPTOR TYROSINE KINASES)
Japan	2010270154	METHOD FOR PRODUCING N4-PHENYL-QUINAZOLINE-4-AMINE DERIVATIVE, AND INTERMEDIATE THEREOF
Australia	2019200243	SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR

Supplementary Protection Certificates for tukysa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1971601	770	Finland
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	132021000000128	Italy		PRODUCT NAME: TUCATINIB OPZIONALMENTE NELLA FORMA DI UN SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(TUKYSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1526, 20210212
1971601	CR 2021 00025	Denmark		PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1526 20210212
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 (Tucatinib)

Last updated: December 29, 2025

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Executive Summary

TUKYSA (tucatinib) is an oral, selective tyrosine kinase inhibitor targeting HER2, developed by Seattle Genetics in partnership with Genentech/Roche. Approved by the FDA in April 2021 for HER2-positive metastatic breast cancer, TUKYSA has rapidly gained market traction owing to its efficacy, safety profile, and expanding indications. This report analyzes key market drivers, competitive landscape, revenue projections, and strategic considerations shaping TUKYSA's financial future.

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Overview of TUKYSA: Indications and Regulatory Milestones

Parameter	Details
Active Ingredient	Tucatinib
Mechanism of Action	HER2 selective tyrosine kinase inhibitor
Primary Indication	HER2-positive metastatic breast cancer (mBC)
FDA Approval Date	April 2021
Additional Indications	Under clinical evaluation for other HER2+ cancers, notably gastric and colorectal cancers

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Market Context: HER2-Positive Breast Cancer Landscape

Parameter	Details
Global Estimated Incidence	2 million new breast cancer cases annually (WHO, 2022)
HER2+ Subtype Prevalence	15–20% of invasive breast cancers (SEER, 2022)
Market Size (U.S.)	~$4.8 billion (IQVIA, 2022 estimates)
Key Competitors	Trastuzumab (Herceptin), Pertuzumab (Perjeta), T-DM1 (Kadcyla), Neratinib, Enhertu
Market Growth Rate	8% CAGR projected through 2027 (GlobalData, 2022)

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Market Drivers for TUKYSA

1. Efficacy in HER2-positive mBC

TUKYSA demonstrated significant improvements in progression-free survival (PFS) and overall response rates (ORR) in pivotal trials, particularly in the HER2CLIMB study, which influenced its approval and adoption.

2. Favorable Safety Profile

Compared to existing therapies, tucatinib offers reduced cardiotoxicity and diarrhea, essential for patient compliance and quality of life enhancements.

3. Expanding Treatment Lines

Initially approved for combination with trastuzumab and capecitabine, ongoing studies aim to position TUKYSA as a backbone for multiple lines and combinations, extending its market potential.

4. Regulatory Approvals Outside the U.S.

Japan and Europe are reviewing TUKYSA for potential approvals, opening additional revenue streams.

5. Strategic Collaborations

Partnerships with Roche/Genentech facilitate global commercialization and clinical development, accelerating access.

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Competitive Landscape and Differentiators

Drug	Mechanism	Line of Therapy	Approval Status	Market Share (2022)	Strengths
Trastuzumab	HER2 monoclonal antibody	Standard first-line for HER2+ mBC	Approved	40%	Longevity, established efficacy
Pertuzumab	HER2 dimerization inhibitor	First- and second-line	Approved	20%	Proven efficacy in early lines
T-DM1	Antibody-drug conjugate (ADC)	Post-trastuzumab progression	Approved	13%	Potent in later lines
Neratinib	Pan-HER TKI	Extended adjuvant, post-trastuzumab	Approved	8%	Oral, convenient
TUKYSA	HER2 selective TKI	+ trastuzumab + capecitabine (initial)	Approved in 2021	10% (post-approval)	Oral, effective monotherapy, better tolerability

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Financial Trajectory Projections

Current Revenue Snapshot (2022)

Region	Estimated Revenue (USD millions)	Key Market Conditions
United States	~$750	Strong adoption in metastatic settings
Europe	~$200	Pending approvals; early-stage uptake
Japan	~$100	Recently approved; market entry phase
Rest of World	~$50	Limited penetration, pipeline expansion

Forecasted Revenue Growth (2023–2027)

Year	Projected Revenue (USD millions)	Comments
2023	~$900	Steady adoption, ramp-up in international markets
2024	~$1,250	Expanded indications, combination approvals, pipeline uptake
2025	~$1,750	Broader payer coverage, clinical evidence solidifies market position
2026	~$2,400	Potential new indications, line extensions
2027	~$3,200	Peak utilization, global commercialization fully realized

Assumptions and Models

• Adoption driven by data from ongoing clinical trials
• Growth influenced by competition, reimbursement, and regulatory factors
• Launch of new indications (e.g., gastric, colorectal) assumed by 2025–2026
• Competitive pricing models maintained to sustain market share

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Key Market Risks and Opportunities

Risks	Opportunities
Competition from established biologics and other TKIs	Expanding indications to gastric and colorectal cancers
Pricing pressures in key markets	Combination therapies with emerging agents
Regulatory delays in new markets	Personalized medicine advancing market penetration
Reimbursement hurdles	Leveraging real-world evidence for payer negotiations

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Strategic Considerations for Stakeholders

• Investors: Focus on pipeline advancement and international approvals to optimize return.
• Pharmaceutical Partners: Prioritize combination therapy trials and label expansions.
• Regulators: Ensure comprehensive data on efficacy, safety, and quality.
• Clinicians: Recognize TUKYSA's benefits, especially in heavily pretreated populations.

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Comparison of TUKYSA with Major Competitors

Feature	TUKYSA	Pertuzumab	T-DM1	Neratinib
Mechanism	HER2 TKI	HER2 dimerization	ADC	Pan-HER TKI
Formulation	Oral	Intravenous	Intravenous	Oral
Line of Use	Later-line, combo regimens	First-line, combos	After trastuzumab-based	Extended adjuvant, tx
Efficacy Metrics (PFS/ORR)	Significant improvement	Standard in early-line	High in selected populations	Variable, ongoing data
Safety Profile	Favorable, less cardiotoxic	Cardiotoxicity concerns	Hematologic and hepatic	Diarrhea, hepatotoxicity

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Regulatory and Policy Landscape

Jurisdiction	Recent Policy Developments
U.S. FDA	Approved in April 2021; now included in NCCN guidelines
Europe EMA	Under review, Decision expected in late 2023
Japan PMDA	Approved in May 2022; expanding access
Reimbursement Policies	Pricing negotiations underway based on value-based frameworks

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Future Outlook and Strategic Pathways

1. Pipeline Expansion: Development of tucatinib in HER2+ gastric, colorectal, and other solid tumors could diversify revenue streams.

2. Line Extension: Data from ongoing trials (e.g., HER2CLIMB-02) could establish tucatinib as frontline therapy, shifting market share dynamics.

3. Global Market Penetration: Increased efforts in Europe, Asia, and emerging markets will be vital.

4. Combination Therapies: Synergies with immunotherapy and novel agents could reinforce tucatinib’s position.

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Key Takeaways

• TUKYSA has demonstrated rapid growth post-approval, with an estimated revenue trajectory reaching ~$3.2 billion by 2027.
• Its efficacy, oral administration, and tolerability profile provide competitive advantages over early-phase biologics and chemotherapies.
• Expansion into new indications, including gastric and colorectal cancers, represents a significant upside.
• Competition remains robust; continual investments in clinical trials and pipeline development are critical.
• International regulatory approvals and payer policies will significantly influence its global market share.

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FAQs

Q1: How does TUKYSA compare to trastuzumab in efficacy?

A: TUKYSA showed superior PFS and ORR in heavily pretreated metastatic HER2+ breast cancer, especially in patients with brain metastases, offering an oral, targeted alternative with favorable safety.

Q2: What are the main advantages of TUKYSA's mechanism?

A: Tucatinib selectively inhibits HER2 with minimal off-target effects, leading to fewer cardiotoxicity issues compared to trastuzumab-based regimens.

Q3: What are the key obstacles for TUKYSA’s market growth?

A: Competition from established biologics, reimbursement hurdles, and delays in approval for additional indications could impede rapid growth.

Q4: What future indications are being explored for TUKYSA?

A: Clinical trials are evaluating tucatinib in HER2-positive gastric, colorectal, and other solid tumors.

Q5: How might global policy developments affect TUKYSA’s trajectory?

A: Regulatory approvals, reimbursement policies, and competitive pricing strategies in Europe, Asia, and emerging markets will influence overall adoption and revenues.

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References

1. [1] U.S. Food and Drug Administration. FDA approves tucatinib for breast cancer. April 2021.
2. [2] WHO. Global cancer statistics 2022.
3. [3] IQVIA. Market analytics report, 2022.
4. [4] GlobalData. HER2-positive breast cancer market forecast, 2022–2027.
5. [5] SEER Program, National Cancer Institute. Breast cancer factsheet, 2022.

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This comprehensive analysis provides a strategic framework to assess TUKYSA's market potential and financial outlook within the evolving landscape of HER2-positive breast cancer therapeutics.