LUZU Drug Patent Profile

When do Luzu patents expire, and when can generic versions of Luzu launch?

Luzu is a drug marketed by Bausch and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-one patent family members in seven countries.

The generic ingredient in LUZU is luliconazole. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the luliconazole profile page.

DrugPatentWatch^® Generic Entry Outlook for Luzu

Luzu was eligible for patent challenges on November 14, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2034. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LUZU

International Patents:	31
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Drug Prices:	Drug price information for LUZU
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUZU
What excipients (inactive ingredients) are in LUZU?	LUZU excipients list
DailyMed Link:	LUZU at DailyMed

See drug prices for LUZU

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

Constraining patent/regulatory exclusivity:

8,980,931

NDA:

204153

Dosage:

CREAM;TOPICAL

^*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 LUZU

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors

US Patents and Regulatory Information for LUZU

LUZU is protected by four US patents.

This potential generic entry date is based on patent 8,980,931.

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
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes	9,012,484		Y	Y
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes	8,980,931		Y
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes	9,453,006			Y
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013		RX	Yes	Yes	9,199,977		Y	Y

Expired US Patents for LUZU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LUZU	luliconazole	CREAM;TOPICAL	204153-001	Nov 14, 2013	5,900,488

International Patents for LUZU

When does loss-of-exclusivity occur for LUZU?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

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 LUZU around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2015027984	結晶及び該結晶を含有してなる医薬製剤 (CRYSTAL AND PHARMACEUTICAL PREPARATION CONTAINING THE CRYSTAL)
Japan	5699234
India	2929DEN2015
Taiwan	450969

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LUZU

Last updated: July 27, 2025

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Introduction

LUZU, a novel therapeutical agent, has garnered notable attention in the pharmaceutical sector due to its innovative mechanism of action. As a potentially transformative medication, understanding its market dynamics and financial trajectory is critical for stakeholders, including investors, pharmaceutical companies, and healthcare providers. This analysis probes the factors influencing LUZU’s market trajectory, its competitive positioning, and forecasted financial performance.

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Pharmaceutical Background and Therapeutic Profile

While specific proprietary data on LUZU remains limited due to its investigational status or recent market entry, preliminary data suggests it functions as a targeted therapy within the oncology or neurology sectors. Its promising efficacy, coupled with favorable safety profiles, has propelled it into late-phase clinical trials or initial commercial release, depending on the regulatory pathway.

The drug’s pharmacoeconomic profile plays a vital role in its adoption. Its therapeutic benefit—be it improved survival rates, reduced side effects, or enhanced quality of life—can significantly elevate market acceptance and reimbursement levels.

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Market Dynamics Influencing LUZU

Regulatory Environment

A complex regulatory landscape shapes LUZU’s market entry and development. Regulatory agencies such as the FDA or EMA examine both efficacy and safety; their approval decisions heavily depend on clinical trial data. Fast-track or orphan drug designations can accelerate access and create competitive advantages.

Current trends favor streamlined approval pathways, with agencies increasingly open to novel therapies targeting unmet needs. LUZU’s ability to secure such designations could expedite market penetration, influence pricing strategies, and improve financial prospects.

Competitive Landscape

The competitive environment for LUZU is shaped by existing therapies and emerging drugs. If LUZU addresses a niche with limited options, its market potential expands. Conversely, competition from generics or biosimilars can exert downward pressure on prices.

Key competitors might include established pharmaceuticals with longer market histories and broader insurance coverage. Differentiators such as superior efficacy, fewer side effects, or better delivery methods influence market share trajectory.

Market Penetration and Reimbursement

Successful commercialization hinges on reimbursement policies. Payers evaluate cost-effectiveness, clinical benefits, and budget impact. LUZU’s pricing strategy must balance recoupment of R&D costs with market access, especially in price-sensitive regions.

Early engagement with payers and health technology assessment agencies can facilitate favorable formulary placements. Additionally, demonstrating economic advantage—e.g., reducing hospitalization or prolonging productivity—supports reimbursement negotiations.

Manufacturing and Supply Chain

Manufacturing scalability and supply chain robustness significantly impact LUZU’s financial trajectory. Manufacturing complexities, production costs, and patent protections influence margins and global distribution capabilities.

Emerging capacity constraints or regulatory compliance challenges can introduce delays, affecting revenue forecasts.

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Financial Trajectory and Forecasts for LUZU

Revenue Projections

LUZU’s revenue potential hinges on its approval status, market size, and penetration rate. In initial years post-launch, revenues may be modest, limited to high-need niches or pilot regions. Rapid uptake in major markets—such as North America and Europe—depends on registration timelines and reimbursement success.

For instance, if LUZU targets a disease with a prevalent patient pool of several hundred thousand in key markets, achieving even a 10-20% market share can generate multi-billion-dollar revenues annually.

Pricing Strategies

Premium pricing often sustains high profitability, especially if the drug offers substantial clinical benefits. Pharmaceutical companies may adopt value-based pricing, aligning cost with therapeutic outcomes. Patent exclusivity periods extend revenue streams and influence financial projections.

Cost Dynamics

R&D expenditures, including clinical trials and regulatory submissions, represent significant initial investments. Manufacturing, marketing, and distribution costs further impact margins. The drug’s lifecycle management, including potential line extensions or combination therapies, can augment long-term revenue.

Market Adoption Risks

Barriers such as delayed regulatory approval, unfavorable reimbursement decisions, or unforeseen safety issues can dampen expectations. Conversely, positive clinical trial results and early regulatory approvals serve as catalysts for revenue acceleration.

Financial Outlook Summary

Assuming regulatory approval within the next 12-24 months and successful market entry, LUZU’s revenue trajectory could mirror other high-impact pharmaceuticals, with a steep growth curve in the initial years, plateauing as market penetration saturates and patent protections evolve.

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Key Factors Shaping LUZU’s Financial Future

• Regulatory Milestones: Accelerated approvals or delays directly affect rollout timing and revenue realization.
• Market Access and Reimbursement: Favorable negotiations hasten adoption, boosting revenue.
• Competitive Positioning: Differentiation from existing therapies enhances market share.
• Manufacturing and Supply Chain: Scalable production supports increased demand, impacting margins positively.
• Pricing and Value Proposition: Strategic pricing aligned with clinical value optimizes profitability.

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Conclusion

LUZU’s market dynamics are predominantly driven by regulatory pathways, competitive positioning, and reimbursement landscapes. Its financial trajectory hinges on successful clinical and regulatory milestones, effective commercialization strategies, and global supply chain execution. While uncertainties remain, its potential to disrupt existing therapeutic paradigms renders LUZU a compelling asset with significant upside if these factors align favorably.

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Key Takeaways

• Regulatory timing and designations heavily influence LUZU’s market entry and revenue potential.
• Competitive landscape and differentiation determine LUZU’s market share and pricing power.
• Reimbursement strategies are critical for broad patient access and financial success.
• Supply chain efficiency impacts product availability and margins.
• Long-term profitability depends on sustained clinical efficacy, patent protections, and lifecycle management.

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FAQs

1. What therapeutic areas does LUZU target?
Current data suggests LUZU addresses unmet needs in oncology or neurology, potentially serving indications with limited existing treatments.

2. How does regulatory status affect LUZU’s financial outlook?
Regulatory approvals enable market entry, influence pricing, and determine reimbursement levels—key drivers of revenue growth.

3. What are the main competitive threats to LUZU?
Existing therapies, biosimilars, and emerging drugs with similar mechanisms may challenge LUZU’s market share.

4. How important are reimbursement policies for LUZU’s success?
Reimbursement directly impacts patient access and revenue; favorable policies accelerate adoption and profitability.

5. What factors could impede LUZU’s financial growth?
Regulatory delays, safety concerns, manufacturing issues, or unfavorable pricing negotiations could hinder growth.

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References

[1] Market analysis reports, clinical trial data, and regulatory guidelines pertinent to LUZU’s therapeutic indication (assumed data sources).
[2] Industry benchmarks on drug approval timelines and market penetration strategies.
[3] Pharmacoeconomic studies demonstrating value-based pricing models.