LAZCLUZE Drug Patent Profile

When do Lazcluze patents expire, and what generic alternatives are available?

Lazcluze is a drug marketed by Janssen Biotech and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and one patent family members in thirty-four countries.

The generic ingredient in LAZCLUZE is lazertinib mesylate. One supplier is listed for this compound. Additional details are available on the lazertinib mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lazcluze

Lazcluze will be eligible for patent challenges on August 19, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LAZCLUZE

International Patents:	101
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in LAZCLUZE?	LAZCLUZE excipients list
DailyMed Link:	LAZCLUZE at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

219008

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 LAZCLUZE

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

US Patents and Regulatory Information for LAZCLUZE

LAZCLUZE is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No			Y	Y
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes			Y	Y
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-001	Aug 19, 2024		RX	Yes	No
Janssen Biotech	LAZCLUZE	lazertinib mesylate	TABLET;ORAL	219008-002	Aug 19, 2024		RX	Yes	Yes
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

International Patents for LAZCLUZE

See the table below for patents covering LAZCLUZE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	102073854
World Intellectual Property Organization (WIPO)	2016060443
Taiwan	I664173
Denmark	3604294
South Korea	20180118535	아미노피리미딘 유도체 화합물의 염, 이의 결정형 및 이의 제조 방법 (A SALT OF AMINOPYRIDINE DERIVATIVE COMPOUND ITS CRYSTALLINE FORM AND A MANUFACTURING PROCESS THEREOF)
Saudi Arabia	519410342	ملح مستخلص من مركب مشتق من الأمينو بيريدين والشكل البلوري منه وعملية تحضيرهما (SALT OF AN AMINOPYRIDINE DERIVATIVE COMPOUND, A CRYSTALLINE FORM THEREOF, AND A PROCESS FOR PREPARING THE SAME)
Eurasian Patent Organization	202193117	КОМБИНИРОВАННЫЕ ТЕРАПИИ С ИСПОЛЬЗОВАНИЕМ БИСПЕЦИФИЧЕСКИХ АНТИТЕЛ К EGFR/c-MET И 3-ГО ПОКОЛЕНИЯ ИНГИБИТОРОВ ТИРОЗИНКИНАЗЫ EGFR

LAZCLUZE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for LAZCLUZE

Introduction

LAZCLUZE (lazertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), has recently been approved by the FDA for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have specific EGFR mutations. This approval marks a significant development in the treatment landscape for NSCLC and has substantial implications for market dynamics and financial trajectories.

Approval and Clinical Significance

The FDA approval of LAZCLUZE in combination with RYBREVANT (amivantamab-vmjw) is based on the positive results from the Phase 3 MARIPOSA study. This study demonstrated that the combination of RYBREVANT and LAZCLUZE reduced the risk of disease progression or death by 30% compared to osimertinib, a standard treatment for EGFR-mutated NSCLC. Patients treated with this combination experienced a significantly longer median progression-free survival (PFS) of 23.7 months, compared to 16.6 months for those treated with osimertinib[1][4].

Market Impact

The approval of LAZCLUZE introduces a new competitor to AstraZeneca’s Tagrisso, which has been a dominant player in the EGFR-mutated lung cancer market. This new combination regimen from Johnson & Johnson is the first chemotherapy-free treatment to demonstrate superiority over Tagrisso in this setting, potentially shifting market share and treatment paradigms[4].

Competitive Landscape

The introduction of LAZCLUZE and RYBREVANT into the market challenges the existing dominance of Tagrisso. While Tagrisso remains a strong competitor, especially with recent data showing improved outcomes when combined with chemotherapy, the LAZCLUZE and RYBREVANT combination offers a chemotherapy-free alternative that could attract patients and clinicians seeking to avoid chemotherapy-related side effects[4].

Patient and Clinician Preferences

The preference for a chemotherapy-free regimen could drive adoption of LAZCLUZE and RYBREVANT. However, it is important to note that about 10% of patients discontinued treatment due to side effects, and there is a safety signal for venous thromboembolic events, which may influence treatment decisions[4].

Financial Trajectory

Revenue Projections

The approval and subsequent market entry of LAZCLUZE are expected to contribute significantly to Johnson & Johnson's revenue. Given the strong clinical data and the first-line treatment designation, LAZCLUZE is poised to capture a substantial share of the EGFR-mutated NSCLC market. Johnson & Johnson's financial guidance for 2024 reflects this optimism, with overall pharmaceutical sales expected to grow by 6.3% globally[5].

Sales Performance

The combination of RYBREVANT and LAZCLUZE is anticipated to be a high-revenue generator. The success of this regimen will be closely tied to its adoption rates and market penetration. As more patients and clinicians opt for this chemotherapy-free treatment, sales are expected to rise, contributing to Johnson & Johnson's overall financial performance.

Cost and Pricing

The pricing strategy for LAZCLUZE will be crucial in determining its market success. Given the competitive landscape, Johnson & Johnson will need to balance the pricing to ensure it remains competitive with other treatments like Tagrisso while also reflecting the value of the improved clinical outcomes.

Distribution and Access

Onco360, a leading independent specialty pharmacy, has been selected as a pharmacy partner for LAZCLUZE. This partnership ensures that patients have access to this critical medication, which is essential for its market success. The distribution network and patient access programs will play a vital role in the financial trajectory of LAZCLUZE[1].

Regulatory and Safety Considerations

The FDA approval comes with certain conditions, including the requirement for prophylactic anticoagulation during the first months of therapy to mitigate the risk of venous thromboembolic events. Compliance with these regulatory requirements will be essential to maintaining market confidence and ensuring patient safety[4].

Industry Expert Insights

Industry experts highlight the significance of this approval in the context of the evolving treatment landscape for NSCLC. As noted by Benito Fernandez, Chief Commercial Officer of Onco360, "We are proud to add this first-line, chemotherapy-free, targeted therapy to our portfolio to treat patients with locally advanced or metastatic EGFR-mutation non-small cell lung cancer."[1]

Key Statistics

• Median Progression-Free Survival (PFS): 23.7 months for RYBREVANT plus LAZCLUZE vs. 16.6 months for osimertinib[1][4].
• Risk Reduction: 30% reduction in the risk of disease progression or death compared to osimertinib[1][4].
• Discontinuation Rate: Approximately 10% of patients discontinued treatment due to side effects[4].

Conclusion

The approval of LAZCLUZE in combination with RYBREVANT marks a significant advancement in the treatment of EGFR-mutated NSCLC. With its superior clinical outcomes and chemotherapy-free regimen, this combination is poised to make a substantial impact on the market dynamics and financial trajectories of Johnson & Johnson and the broader pharmaceutical industry.

Key Takeaways

• Clinical Superiority: LAZCLUZE and RYBREVANT combination shows superior PFS and reduced risk of disease progression or death compared to osimertinib.
• Market Impact: Introduces a new competitor to Tagrisso, potentially shifting market share.
• Financial Projections: Expected to contribute significantly to Johnson & Johnson's revenue growth.
• Distribution and Access: Partnership with Onco360 ensures patient access.
• Regulatory Considerations: FDA approval includes requirements for prophylactic anticoagulation.

FAQs

1. What is LAZCLUZE, and how is it used? LAZCLUZE (lazertinib) is a third-generation EGFR TKI used in combination with RYBREVANT (amivantamab-vmjw) for the first-line treatment of adult patients with metastatic NSCLC who have specific EGFR mutations.

2. What are the key clinical benefits of LAZCLUZE and RYBREVANT? The combination reduces the risk of disease progression or death by 30% and extends median PFS to 23.7 months compared to osimertinib.

3. How does LAZCLUZE compare to other treatments like Tagrisso? LAZCLUZE and RYBREVANT offer a chemotherapy-free regimen that has demonstrated superiority to Tagrisso in clinical trials.

4. What are the potential side effects of LAZCLUZE and RYBREVANT? Approximately 10% of patients discontinued treatment due to side effects, and there is a safety signal for venous thromboembolic events.

5. Who is the pharmacy partner for LAZCLUZE? Onco360 has been selected as a pharmacy partner for LAZCLUZE, ensuring patient access to this medication.

Sources

1. Biospace: LAZCLUZE™ (lazertinib) Now Available from Onco360 for the First-Line Treatment in Combination with RYBREVANT® (amivantamab-vmjw) of Adult Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Have EGFR Exon 19 Deletions or Exon 21 L858R Mutations.
2. PR Newswire: HALOZYME REPORTS THIRD QUARTER 2024 FINANCIAL AND OPERATING RESULTS.
3. Sanofi: Sanofi Q2: strong performance with 10% sales growth; 2024 financial guidance raised.
4. BioPharma Dive: J&J drug combo for lung cancer approved by FDA.
5. Johnson & Johnson: JNJ.N - Q3 2024 Johnson & Johnson Earnings Call.