LAZERTINIB MESYLATE - Generic Drug Details

What are the generic drug sources for lazertinib mesylate and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for LAZERTINIB MESYLATE

International Patents:	101
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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	219008-001	Aug 19, 2024		RX	Yes	No
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	11,981,659
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No	11,850,248

International Patents for LAZERTINIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Brazil	112019021868	sal de um composto derivado de aminopiridina, forma cristalina do mesmo, e processo para a preparação do mesmo
Taiwan	I776882
Spain	2879474

LAZERTINIB MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lazertinib Mesylate

Introduction to Lazertinib Mesylate

Lazertinib mesylate, also known as Leclaza, is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) developed by Johnson & Johnson. It is specifically designed to treat patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with EGFR-TKIs[1][4].

Clinical Development and Approval

Lazertinib is currently in the pre-registration phase for NSCLC, with a high likelihood of approval. According to GlobalData, drugs in the pre-registration phase for NSCLC have an 80% phase transition success rate (PTSR) benchmark for progressing into the marketed phase[1].

Recently, the U.S. Food and Drug Administration (FDA) approved the combination of RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) as a first-line, chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. This approval is based on the Phase 3 MARIPOSA trial results, which showed superior progression-free survival compared to osimertinib[4].

Market Potential

The market potential for lazertinib is significant, particularly when used in combination therapies. Here are some key points:

Combination Therapy

The combination of RYBREVANT® and LAZCLUZE™ has demonstrated a reduced risk of disease progression or death by 30% compared to osimertinib, with a nine-month longer median duration of response. This combination is expected to be a game-changer in the treatment of EGFR-mutated NSCLC[4].

Market Share and Revenue Projections

Analysts forecast that lazertinib, especially in combination with amivantamab, could achieve peak sales of at least $5 billion. In Korea, it is projected to generate significant revenue as a first-line treatment for NSCLC, with estimated domestic revenue of W88.8 billion and operating profit of W48.8 billion in 2024. The drug is expected to capture a 50% market share in 2024 and a 75% share in 2025[3].

Pricing and Insurance Coverage

The drug price is estimated at W144,824 daily, with a 30% reduction due to insurance coverage. This pricing strategy, combined with the expected market share, positions lazertinib for substantial revenue growth[3].

Financial Trajectory

Revenue Forecasts

Janssen and analysts predict robust financial performance for lazertinib. The combination therapy of amivantamab and lazertinib is expected to drive significant revenue, with peak sales projected to exceed $5 billion. This forecast is supported by the strong clinical data and the drug's potential to become a first-line treatment globally[3][4].

Operating Profit and Margins

In Korea, the operating profit margin for lazertinib is estimated to be around 50%, which is highly favorable. The production costs and selling, general, and administrative (SG&A) expenses are expected to be 5% and 30% of revenue, respectively, further supporting the drug's financial viability[3].

Global Expansion

The approval and success of lazertinib in the U.S. and other markets are expected to drive global expansion. With a strong clinical profile and favorable market dynamics, lazertinib is poised to become a global blockbuster, particularly in regions where EGFR-mutated NSCLC is prevalent[4].

Safety and Efficacy

Clinical Trial Data

The safety and efficacy of lazertinib, both as a monotherapy and in combination with other drugs like RYBREVANT®, have been well-documented. The MARIPOSA phase 3 trial showed that the combination of RYBREVANT® and LAZCLUZE™ reduced the risk of disease progression or death by 30% compared to osimertinib, with no new safety signals or additional toxicity observed[2][4].

Adverse Events

Common treatment-emergent adverse events include neutropenia, rash, infusion-related reactions, stomatitis, fatigue, paronychia, thrombocytopenia, and nausea. However, the overall safety profile is consistent with the previously reported safety profiles of the individual agents[2].

Competitive Landscape

Lazertinib competes in the EGFR-TKI market, where drugs like osimertinib are established. However, the superior progression-free survival and longer median duration of response demonstrated by the combination of RYBREVANT® and LAZCLUZE™ position lazertinib as a leading contender in this space[4].

Regulatory Environment

The FDA approval of RYBREVANT® plus LAZCLUZE™ as a first-line treatment for EGFR-mutated NSCLC highlights the favorable regulatory environment for this drug. This approval follows a Priority Review, indicating the drug's significant clinical benefit[4].

Conclusion

Lazertinib mesylate is poised for significant market impact and financial success due to its strong clinical profile, favorable market dynamics, and regulatory approvals. Here are the key takeaways:

• Strong Clinical Data: Superior progression-free survival and longer median duration of response compared to existing treatments.
• Market Potential: Projected peak sales of at least $5 billion, with a significant market share in Korea and global expansion potential.
• Financial Trajectory: Estimated domestic revenue of W88.8 billion and operating profit of W48.8 billion in Korea, with a 50% operating profit margin.
• Safety and Efficacy: Well-documented safety profile with no new safety signals, and a favorable adverse event profile.
• Competitive Landscape: Positions lazertinib as a leading contender in the EGFR-TKI market.

Key Takeaways

• Clinical Success: Lazertinib has shown superior clinical outcomes in combination with RYBREVANT®.
• Market Dominance: Expected to capture a significant market share in the NSCLC treatment market.
• Financial Growth: Projected to generate substantial revenue and operating profit.
• Regulatory Approval: FDA approval as a first-line treatment for EGFR-mutated NSCLC.
• Global Expansion: Potential for global market expansion driven by strong clinical data and regulatory approvals.

FAQs

1. What is lazertinib mesylate used for?

   • Lazertinib mesylate is used for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with EGFR-TKIs[1].

2. What is the current regulatory status of lazertinib?

   • Lazertinib, in combination with RYBREVANT®, has been approved by the FDA as a first-line, chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer[4].

3. What are the projected peak sales for lazertinib?

   • The combination therapy of amivantamab and lazertinib is expected to achieve peak sales of at least $5 billion[3].

4. What is the safety profile of lazertinib?

   • The safety profile of lazertinib is consistent with the previously reported safety profiles of the individual agents, with common adverse events including neutropenia, rash, and fatigue[2].

5. How does lazertinib compare to other EGFR-TKIs?

   • Lazertinib, in combination with RYBREVANT®, has shown superior progression-free survival and a longer median duration of response compared to osimertinib[4].

Sources

1. Pharmaceutical Technology: "Lazertinib by Johnson & Johnson for Non-Small Cell Lung Cancer"
2. Johnson & Johnson: "Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT® and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations"
3. Mirae Asset Securities Research: "Growing expectations for lazertinib; raise TP"
4. Johnson & Johnson: "RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) Approved in the U.S. as a First-Line Chemotherapy-Free Treatment for Patients with EGFR-Mutated Advanced Lung Cancer"