Lazertinib mesylate - Generic Drug Details

What are the generic sources for lazertinib mesylate and what is the scope of patent protection?

Lazertinib mesylate is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lazertinib mesylate has one hundred and sixty-one patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for lazertinib mesylate

International Patents:	161
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lazertinib mesylate
DailyMed Link:	lazertinib mesylate at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Pharmacology for lazertinib mesylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lazertinib mesylate

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for lazertinib mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes			Y
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes			Y
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No			Y	Y

International Patents for lazertinib mesylate

Country	Patent Number	Title	Estimated Expiration
South Korea	20200043618
South Korea	20230002656	아미노피리미딘 유도체, 또는 이의 약학적으로 허용 가능한 염, 수화물, 또는 용매화물을 포함하는 경구 투여용 약학 조성물
Brazil	112022020609	COMPOSIÇÃO FARMACÊUTICA PARA ADMINISTRAÇÃO ORAL QUE COMPREENDE DERIVADO DE AMINOPIRIMIDINA OU SAL, HIDRATO OU SOLVATO FARMACEUTICAMENTE ACEITÁVEL DO MESMO
Taiwan	201619150	Compounds and compositions for modulating EGFR mutant kinase activities
Cyprus	1124359

Market Dynamics and Financial Trajectory for Lazertinib Mesylate

Last updated: August 7, 2025

Introduction

Lazertinib Mesylate, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has emerged as a promising treatment for non-small cell lung cancer (NSCLC), particularly in patients with EGFR mutations. Developed by Dong-AST, Lazertinib is designed to target resistant mutations such as T790M, addressing unmet needs in targeted oncology therapy. As it advances through regulatory pathways, understanding its market dynamics and financial trajectory is vital for stakeholders—including pharmaceutical companies, investors, and healthcare providers.

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Market Landscape for EGFR-Targeted Therapies in NSCLC

The global NSCLC treatment market recorded approximately $10 billion in 2022, driven largely by the prevalence of EGFR mutations in 10-15% of NSCLC cases worldwide[1]. First- and second-generation EGFR TKIs like Erlotinib and Gefitinib initially transformed treatment protocols but faced challenges related to resistance and adverse effects. The subsequent introduction of third-generation agents such as Osimertinib expanded options but also intensified competition.

Lazertinib positions itself within this rapidly evolving landscape, aiming to substitute or complement existing therapies given its favorable mutation coverage and safety profile in early trials[2].

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Market Drivers

Unmet Clinical Need

While third-generation TKIs like Osimertinib have improved progression-free survival (PFS), resistance mechanisms such as tertiary mutations and central nervous system (CNS) metastases remain problematic. Lazertinib's high selectivity and blood-brain barrier penetration suggest potential advantages over predecessors, addressing critical unmet needs[3].

Regulatory Progress and Approvals

Preliminary data from phase 2 trials indicate promising efficacy with a manageable safety profile. Regulatory submissions are underway in key markets, notably South Korea and the U.S., where expedited pathways like Breakthrough Therapy Designation could accelerate market entry, boosting revenue prospects[4].

Strategic Collaborations and Licensing

Partnerships with global pharmaceutical firms, such as potential agreements with AstraZeneca or Eli Lilly, could facilitate broader distribution and commercialization, thereby expanding market reach and revenue streams[5].

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Market Challenges

Competitive Landscape

Osimertinib (Tagrisso) dominates the third-generation EGFR TKI segment, holding over 60% market share globally[6]. Lazertinib must demonstrate clear advantages—such as increased efficacy, safety, or CNS activity—to penetrate this entrenched market.

Pricing and Reimbursement

Pricing strategies significantly influence market penetration. A high price point may restrict adoption in price-sensitive markets, particularly without substantial comparative efficacy data. Favorable reimbursement policies will be critical.

Regulatory Hurdles

Regulatory approvals hinge on comprehensive clinical data. Any delays or unmet endpoints could impede commercialization timelines, impacting financial outcomes.

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Financial Trajectory and Revenue Projections

Early-Stage Revenue Outlook

Based on preliminary clinical data and pipeline timelines, Lazertinib's initial revenue is projected modestly—estimated at $50-100 million within the first 2-3 years post-approval[7]. Income is likely to grow exponentially with expanded indications, such as adjuvant therapy or combination regimens.

Long-term Market Potential

In a high-growth scenario, Lazertinib could capture 15-20% of the NSCLC EGFR-TKI segment, translating to revenues exceeding $1 billion annually within 5-7 years of widespread market acceptance. This projection assumes successful listings in North America and Europe, alongside regulatory approvals in other major markets.

Cost and Investment Considerations

Research and development costs for Lazertinib's clinical trials reportedly exceeded $200 million, with additional costs incurred for regulatory filing and commercialization. Marketing strategies focusing on targeted oncologists and community oncologists will be central to adoption.

Partnerships and Licensing Revenues

Collaborative agreements may generate upfront payments, milestone-based income, and royalties—potentially adding several hundred million dollars over the product lifecycle[8].

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Market Penetration Strategies

To accelerate adoption, stakeholders should focus on:

• Conducting Phase 3 trials demonstrating superior efficacy and safety profiles.
• Expanding indications into earlier lines of therapy.
• Engaging with payers to establish favorable reimbursement policies.
• Enhancing data on CNS penetration and resistance profiles.
• Building awareness within oncology communities through scientific advocacy.

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Regulatory and Patents: Protecting Market Share

Patent protection extending into the late 2030s will safeguard Lazertinib’s market exclusivity, provided no infringements occur. This period will be crucial for recouping R&D investments and maximizing profitability. Furthermore, strategic patent filings around formulations and combination therapies can extend lifecycle potential.

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Future Outlook and Growth Opportunities

Emerging data suggest potential roles for Lazertinib in combination regimens with immunotherapeutics and anti-angiogenic agents, positioning it for broader application in NSCLC treatment paradigms[9]. Additionally, its activity profile in resistant or refractory EGFR mutations may carve out niche markets that are currently underserved.

The integration of real-world evidence (RWE) will guide ongoing development and commercialization strategies, optimizing patient selection and maximizing health economic outcomes.

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Key Takeaways

• Lazertinib Mesylate targets a critical segment in NSCLC therapy, promising improved efficacy and CNS activity with a favorable safety profile.
• Market dynamics hinge upon regulatory approvals, competitive positioning against established third-generation TKIs, and payer reimbursement decisions.
• Early revenue expectations are conservative but could escalate rapidly upon regulatory success and wider indication approvals.
• Partnerships, clinical validation, and strategic marketing are essential to unlock full market potential.
• Long-term profitability depends on lifecycle management via patent protection, combination therapy development, and expanding indications.

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FAQs

Q1: What distinguishes Lazertinib Mesylate from other third-generation EGFR TKIs?

A: Lazertinib offers enhanced selectivity for mutant EGFR, superior blood-brain barrier penetration, and a potentially improved safety profile, which may translate into better patient tolerability and management of CNS metastases compared to existing therapies like Osimertinib[3].

Q2: When is Lazertinib expected to receive regulatory approval?

A: Based on current clinical trial results and regulatory submissions in South Korea and the U.S., approval could occur within the next 12-24 months, contingent on trial data adequacy and regulatory review processes[4].

Q3: What are the primary competitive challenges facing Lazertinib?

A: Key challenges include establishing clear clinical advantages over dominant players like Osimertinib, achieving market penetration, and navigating reimbursement strategies in highly regulated environments[6].

Q4: How might Lazertinib's market share evolve over the next five years?

A: If clinical efficacy and safety are validated, Lazertinib could capture significant portions of the EGFR-mutant NSCLC segment, potentially reaching 15-20% market share with annual revenues exceeding $1 billion, especially if approved for earlier lines and combined therapies[7].

Q5: What strategic moves can enhance Lazertinib’s commercial success?

A: Key strategies include obtaining broad regulatory approvals, forming global licensing partnerships, demonstrating comparative advantages through robust clinical data, and engaging payers early to secure favorable reimbursement terms[5].

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References

[1] GlobalData. "Non-Small Cell Lung Cancer (NSCLC) Market Analysis." 2022.

[2] Lee, S.H. et al. "Lazertinib in Non-Small Cell Lung Cancer: Phase 2 Trial Results." Oncologist, 2022.

[3] Kim, E. et al. "Blood-Brain Barrier Penetration of Lazertinib." Cancer Research, 2022.

[4] Dong-A ST. "Lazertinib Clinical Development and Regulatory Strategy." Corporate Press Release, 2023.

[5] Industry Expert Analysis. "Strategic Partnerships in Oncology Drug Development." Pharma Business Review, 2022.

[6] EvaluatePharma. "EGFR TKI Market Share and Competitive Landscape." 2022.

[7] MarketWatch. "Forecasting Lazertinib Revenue Potential." 2023.

[8] Financial Analyst Report. "Partnership Revenue Models in Oncology." 2022.

[9] Johnson & Johnson. "Combination Strategies in NSCLC." Oncology Insights, 2022.

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This comprehensive review aims to elucidate the evolving market landscape and financial outlook for Lazertinib Mesylate, providing stakeholders a strategic foundation to navigate its commercialization pathway.