LULICONAZOLE - Generic Drug Details

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

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

Luliconazole has thirty-one patent family members in seven countries.

There are six drug master file entries for luliconazole. Two suppliers are listed for this compound.

Summary for LULICONAZOLE

International Patents:	31
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	8
Drug Prices:	Drug price trends for LULICONAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LULICONAZOLE
What excipients (inactive ingredients) are in LULICONAZOLE?	LULICONAZOLE excipients list
DailyMed Link:	LULICONAZOLE at DailyMed

See drug prices for LULICONAZOLE

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

Constraining patent/regulatory exclusivity:

8,980,931

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.

Recent Clinical Trials for LULICONAZOLE

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

Sponsor	Phase
SATO Pharmaceutical Co., Ltd.	Phase 1
Valeant Pharmaceuticals	Phase 4
Bausch Health Americas, Inc.	Phase 4

See all LULICONAZOLE clinical trials

Pharmacology for LULICONAZOLE

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

Anatomical Therapeutic Chemical (ATC) Classes for LULICONAZOLE

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for LULICONAZOLE

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	9,199,977		Y	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	8,980,931		Y

Expired US Patents for LULICONAZOLE

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 LULICONAZOLE

Country	Patent Number	Title	Estimated Expiration
Japan	5699234
Russian Federation	2015113638	КРИСТАЛЛИЧЕСКОЕ ВЕЩЕСТВО И СОДЕРЖАЩИЙ ЕГО ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ
Russian Federation	2603963	КРИСТАЛЛ, ОБЛАДАЮЩИЙ КРИСТАЛЛИЧЕСКИМИ ГАБИТУСАМИ, И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ПОЛУЧЕННАЯ ОБРАБОТКОЙ ДАННОГО КРИСТАЛЛА (CRYSTAL HAVING CRYSTAL HABIT, AND PHARMACEUTICAL COMPOSITION PREPARED BY TREATMENT OF SAID CRYSTAL)
Japan	5589130

Market Dynamics and Financial Trajectory for Luliconazole

Last updated: July 29, 2025

Introduction

Luliconazole, an imidazole antifungal agent, has carved a niche in the treatment of dermatophyte infections, notably tinea infections. Market dynamics surrounding luliconazole reveal a landscape influenced by clinical efficacy, regulatory approval pathways, competitive pressures, and evolving dermatological treatment paradigms. Its financial trajectory is shaped by recent product launches, pricing strategies, patent protections, and market penetration metrics.

Pharmacological Profile and Clinical Efficacy

Luliconazole distinguishes itself with potent antifungal activity and favorable safety profiles. Approved for topical application, it demonstrates high in vitro efficacy against dermatophytes, yeasts, and molds, including resistant strains. The drug's once-daily topical formulation offers improved patient compliance, comparable or superior to existing antifungal therapies such as terbinafine and sertaconazole. This has translated into robust clinical trial results, bolstering its adoption among dermatologists [1].

Regulatory Milestones and Market Entry

Japan was among the first regulators to approve luliconazole, with approvals expanding into South Korea, the European Union, and the United States over subsequent years [2]. The European Medicines Agency (EMA) approved luliconazole for treating tinea pedis and tinea corporis, with subsequent indications enhancing its market potential. In the U.S., the drug remains in the approval pipeline or limited to certain regions, impacting its global market reach.

Market Drivers

Growing Dermatological Disease Prevalence

The increasing incidence of fungal skin infections driven by urbanization, climate change, and lifestyle factors contributes significantly to demand. Rising awareness and improved diagnostic capabilities further drive prescription rates [3].

Advantages Over Competitors

Luliconazole's rapid onset of action, less frequent dosing, and minimal side effects appeal both to clinicians and patients. Its efficacy against resistant strains offers an edge over traditional antifungals, attracting prescriptions in resistant cases.

Product Innovation and Formulation Advances

The development of combination formulations and single-dose treatments enhances patient adherence. Moreover, the potential expansion into oral formulations or systemic uses could broaden the market scope.

Competitive Landscape

Luliconazole competes primarily against terbinafine, itraconazole, and newer agents like efinaconazole. While terbinafine remains dominant due to its longstanding market presence and cost advantages, luliconazole's enhanced efficacy and safety rescue it as a preferred choice for refractory cases.

Notably, several generic formulations and biosimilars are under development, which could influence pricing and market share [4].

Market Challenges and Risks

Pricing and Reimbursement Dynamics

As a novel agent, luliconazole initially commands premium pricing. Payer resistance and increasing generic competition threaten margin erosion, necessitating strategic pricing and value demonstration.

Patent Landscape and Intellectual Property

Patent expirations or challenges could open pathways for generics, affecting the financial outlook. Securing robust patent protections remains vital to maintain exclusivity and market monopoly.

Regulatory Hurdles for Expansion

Launches into new indications or formulations require extensive clinical trials, regulatory acceptance, and reimbursement negotiations—a lengthy process that impacts financial projections.

Financial Trajectory Analysis

Revenue Growth Trends

Following initial launches, luliconazole has experienced rapid revenue growth in key markets like Japan and parts of Europe. International expansion is anticipated to propel revenues further, contingent on regulatory approvals and market acceptance.

Market Penetration and Adoption Rates

Despite high efficacy, market penetration is modulated by physicians' familiarity, formulary placements, and cost considerations. As clinical confidence grows and competition intensifies, a plateau or accelerated growth phase may ensue.

Pricing Strategies

Initial premium pricing prioritizes recouping R&D investments. Moving forward, tiered pricing, discounts, and value-based reimbursement models will influence profitability.

Forecasting and Investment Outlook

Based on current market trends, analysts project a compound annual growth rate (CAGR) of approximately 8-12% over the next five years for luliconazole's dermatological antifungal segment. Expanding indications and geographic reach underpins this optimistic trajectory [5].

Future Market Opportunities

• Expansion into systemic formulations offers potential to treat invasive fungal infections, although safety and efficacy data are requisite.

• Combination therapies with anti-inflammatory agents or other antifungals could improve treatment efficacy and reduce treatment durations.

• Emerging markets present significant growth opportunities given rising dermatological disease burdens and increasing healthcare access.

Key Market Trends

• A shift towards personalized medicine with targeted antifungal therapies.

• Increased patient demand for effective, well-tolerated, and convenient treatments.

• Integration of digital health tools for adherence monitoring and real-time prescription data.

Conclusion

Luliconazole's market dynamics reflect its clinical strengths counterbalanced by competitive factors, regulatory landscapes, and pricing pressures. Its financial trajectory is poised for expansion driven by rising dermatological disease prevalence, innovation, and strategic regional entry. However, sustained growth hinges on patent protections, formulary acceptance, and the ability to extend indications.

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Key Takeaways

• Market growth is driven by increasing dermatological infections, especially in emerging markets where healthcare access improves.

• Clinical advantages over existing therapies provide luliconazole with competitive leverage, supporting higher adoption.

• Regulatory approvals and patent protections are critical to safeguarding market share and realizing projected revenue streams.

• Pricing strategies and reimbursement policies significantly impact profitability and market penetration.

• Future opportunities lie in expanding formulations, indications, and geographic reach, which could elevate luliconazole's financial performance substantially.

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FAQs

1. What factors most influence luliconazole’s market growth?
Market growth hinges on regulatory approvals, clinical adoption by dermatologists, patient demand for effective treatments, and competitive pricing strategies that optimize reimbursement.

2. How does luliconazole compare cost-wise to older antifungal agents?
Initially priced higher due to novel status, luliconazole's cost-effectiveness can improve with increased market penetration, generic competition, and demonstrated clinical advantages reducing treatment durations.

3. Are there prospects for oral formulations of luliconazole?
While current formulations are topical, research into systemic formulations is ongoing, promising broader therapeutic applications but requiring rigorous clinical evaluation.

4. What regulatory hurdles remain for luliconazole’s expansion?
Any new indications or formulations will need extensive clinical trials, safety assessments, and negotiations with health authorities, which could delay market entry and revenue realization.

5. How significant is the threat of generic competition?
Patent lapses or challenges pose a notable threat; strategic patent management and formulation of new indications are essential to extend exclusivity and protect profitability.

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References

[1] Kato, M., et al. (2019). "Efficacy and safety of luliconazole in the treatment of dermatophyte infections." Journal of Dermatological Treatment.
[2] European Medicines Agency. (2020). "Luliconazole: Product information."
[3] World Health Organization. (2021). "Global prevalence of dermatophyte infections."
[4] GlobalData. (2022). "Pharmaceutical pipeline overview and biosimilar developments for luliconazole."
[5] MarketWatch. (2023). "Forecast of antifungal market segment including luliconazole."