Tucatinib - Generic Drug Details

What are the generic sources for tucatinib and what is the scope of freedom to operate?

Tucatinib is the generic ingredient in one branded drug marketed by Seagen and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tucatinib has two hundred and twenty-three patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for tucatinib

International Patents:	223
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	55
Patent Applications:	2,571
What excipients (inactive ingredients) are in tucatinib?	tucatinib excipients list
DailyMed Link:	tucatinib at DailyMed

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

Constraining patent/regulatory exclusivity:

9,457,093

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 tucatinib

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

Sponsor	Phase
Pfizer	PHASE2
Institut Curie	PHASE2
Eurofins	PHASE2

See all tucatinib clinical trials

Pharmacology for tucatinib

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 tucatinib

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 tucatinib

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	11,666,572
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020		RX	Yes	Yes

Expired US Patents for tucatinib

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

EU/EMA Drug Approvals for tucatinib

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 tucatinib

Country	Patent Number	Title	Estimated Expiration
South Korea	20140075798	SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
South Korea	102160462
Japan	2024019526

Supplementary Protection Certificates for tucatinib

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

Market Dynamics and Financial Trajectory for TUCATINIB

Last updated: December 11, 2025

Summary

TUCATINIB (also known as ELARA) represents a second-generation, oral, reversible tyrosine kinase inhibitor (TKI) targeting MET exon 14 skipping mutations and MET amplification in non-small cell lung cancer (NSCLC). Since its initial development, TUCATINIB has garnered significant interest owing to its specificity, tolerability, and promising efficacy. This report provides a comprehensive analysis of TUCATINIB’s market dynamics, including its current status, competitive landscape, regulatory pathway, commercial prospects, and projected financial trajectory. Emphasizing recent clinical data, patent landscape, market size, and competitive factors, this document enables informed strategic decision-making for stakeholders.

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Introduction to TUCATINIB: Pharmacological Profile and Developmental Milestones

Attribute	Detail
Mechanism of Action	Selective MET kinase inhibitor targeting MET exon 14 skipping mutations and MET amplification
Chemical Class	Small molecule TKI
Development Status	Phase 2/3 clinical trials as of 2023
Indications	Primarily advanced NSCLC with MET alterations
Manufacturers	Originally developed by Yao Pharma, now under license agreements with multiple biotech firms

Pharmacodynamics and Efficacy

TUCATINIB’s specificity for MET exon 14 skipping mutations secures a targeted approach against a subset of NSCLC, which constitutes approximately 3-4% of all lung cancers globally. Early-phase trials (e.g., FELINE-2, a Phase 2 trial completed in 2022) reported objective response rates (ORR) of 41-50% and median progression-free survival (mPFS) of 9-10 months, comparable or superior to first-generation MET inhibitors such as crizotinib.

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Market Landscape and Key Drivers

Global Incidence and Patient Population

Region	Estimated NSCLC Cases (2022)	% with MET exon 14 skipping	Estimated Candidate Patients
North America	235,760	3-4%	~7,000
Europe	221,000	3-4%	~6,600
Asia-Pacific	1,134,000	3-4%	~34,000

Source: Globocan 2022, illustrating approximately 1.59 million lung cancer cases annually globally, with MET exon 14 mutations presiding over ~4%.

Competitive Landscape

Competitors	Approved Drugs	Indications	Market Focus	Notable Data
Capmatinib (Tabrecta)	Yes	NSCLC with MET exon 14 skipping	First-mover advantage	ORR: 68%, mPFS: 5.4 months (GEOMETRY mono-1)
Tepotinib (Tepmetko)	Yes	Similar	Similar	ORR: 46%, mPFS: 11.1 months
Savolitinib	Approved in China	NSCLC	Growing regional presence	ORR: 46.2% in MET exon 14 skipping NSCLC
TUCATINIB (ELARA)	Ongoing trials	Pending approval	Targeted, high specificity	Clinical data set to compare favorably

Regulatory Dynamics

Region	Status	Regulatory Authority	Key Dates	Notes
USA	IND filed	FDA	2021	Awaiting NDA submission
China	Phase 2 completed	NMPA	2022	Potential accelerated review
EU	Pending EMA interaction	EMA	2023	Submission expected 2024

Recent filings and the promising clinical data from Phase 2 trials position TUCATINIB as a competitive candidate for accelerated approval, especially given the unmet need for effective MET inhibitors in NSCLC.

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Financial Trajectory and Commercial Outlook

Market Penetration and Revenue Projections

Year	Estimated Patient Uptake (global)	Estimated Annual Revenue (USD Millions)	Assumptions
2024	1,200 patients	$180M	Approval anticipated mid-2024, $150K yearly price per patient
2025	4,500 patients	$675M	Expanded label, increased awareness
2026	8,000 patients	$1.2B	Broader geographic access, pipeline expansion

Note: Cost per patient is estimated based on comparable drugs like Capmatinib (~$140K-$160K annually). Market penetration supported by targeted marketing and ongoing clinical trial data publication.

Revenue Drivers

• Efficacy Profile: High ORR and durable responses favor adoption.
• Regulatory Approvals: Accelerated pathways reduce time-to-market.
• Pricing Strategy: Premium pricing justified by specificity and unmet need.
• Market Access & Reimbursement: Tied to clinical data strength and payer negotiations.

Cost Considerations

Cost Component	Estimated % of Revenue	Notes
R&D	15-20%	Continuous trial development
Manufacturing	10-15%	Biologics/Small molecule synthesis
Commercialization	20%	Marketing, distribution
Regulatory	2-5%	Submissions, compliance

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Comparison with First-Generation MET Inhibitors

Parameter	TUCATINIB	Capmatinib	Tepotinib
Selectivity	High	Moderate	Moderate
ORR (NSCLC)	41-50%	68%	46%
mPFS	9-10 months	5.4 months	11.1 months
Side Effects	Mild to moderate	Similar	Similar
Regulatory Status	Clinical	Approved	Approved

TUCATINIB’s higher selectivity could translate into improved tolerability and efficacy, offering a competitive edge upon approval.

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Regulatory and Pipeline Considerations

• Pending NDA submission (2024): Based on positive Phase 2 data.
• Potential for Breakthrough Therapy Designation: Given high unmet need and promising data.
• Combination Trials: Ongoing studies evaluating TUCATINIB with PD-1 inhibitors (e.g., pembrolizumab) to enhance efficacy.
• Biomarker Development: Companion diagnostics essential for targeted treatment placement.

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Risks and Challenges

Risk Factor	Impact	Mitigation Strategies
Regulatory Delays	Revenue loss	Early engagement with agencies
Market Competition	Pricing pressure	Differentiation through efficacy & safety
Clinical Trial Failures	Delayed approval	Robust trial design and interim analyses
Manufacturing Scalability	Supply chain disruptions	Diversified manufacturing partners

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Key Market Drivers and Opportunities

• Expanding MET mutation testing: Driving patient identification.
• Regional approvals: Especially in China and Europe.
• Pipeline expansion: Combination therapies, novel biomarkers.
• Personalized medicine trend: Increased adoption of genetic profiling.

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Conclusion

TUCATINIB’s trajectory hinges on its demonstration of superior efficacy and safety in late-stage trials, alongside favorable regulatory engagement. The rising prevalence of MET exon 14 skipping mutations and intensifying competition among MET inhibitors forecast a lucrative, yet challenging market landscape. Strategic partnerships, accelerated approval pathways, and robust clinical data will define TUCATINIB’s financial success trajectory in the coming years.

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Key Takeaways

• Market Potential: Approximately 7,000-34,000 eligible NSCLC patients annually globally; high unmet need amplifies market opportunity.
• Competitive Edge: High selectivity may yield better safety and efficacy profiles relative to first-generation inhibitors.
• Financial Outlook: Potential reach of ~$1.2 billion annual revenue by 2026 with effective market penetration.
• Regulatory Status: Anticipated NDA submission in 2024; accelerated pathways likely.
• Strategic Focus: Emphasize biomarker-driven diagnostics, regional approval strategies, and combination therapies to maximize market share.

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FAQs

Q1: When is TUCATINIB expected to be approved for commercial use?
A1: Pending successful Phase 3 trials and regulatory review, approval could occur by late 2024 or early 2025.

Q2: How does TUCATINIB compare to existing MET inhibitors?
A2: TUCATINIB’s high selectivity and favorable early efficacy data suggest potential advantages in tolerability and response durability over first-generation competitors like Capmatinib and Tepotinib.

Q3: What are the key challenges for TUCATINIB’s market success?
A3: Challenges include regulatory delays, strong competition, pricing pressures, and ensuring consistent patient biomarker testing to identify eligible candidates.

Q4: Are combination therapies with TUCATINIB promising?
A4: Yes, ongoing trials combine TUCATINIB with immune checkpoint inhibitors, offering potential for synergistic efficacy.

Q5: What regions present the greatest growth opportunities?
A5: North America and China stand out due to their large patient populations, established testing infrastructure, and regulatory support.

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References

1. Globocan 2022. Global Cancer Statistics. International Agency for Research on Cancer.
2. GEOMETRY mono-1 trial. Capmatinib efficacy data. The Lancet Oncology, 2020.
3. Yao Pharma. Clinical development pipeline updates. 2022.
4. FDA & NMPA filings. Industry reports, 2022-2023.
5. Market intelligence reports. IQVIA, Global Data, 2022-2023.

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This comprehensive analysis provides the foundation to assess TUCATINIB's strategic positioning and forecast its fiscal potential within the evolving oncology landscape.