LOTRISONE Drug Patent Profile

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

Lotrisone is a drug marketed by Organon and Merck Sharp Dohme and is included in two NDAs.

The generic ingredient in LOTRISONE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for LOTRISONE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	1
Drug Prices:	Drug price information for LOTRISONE
Drug Sales Revenues:	Drug sales revenues for LOTRISONE
What excipients (inactive ingredients) are in LOTRISONE?	LOTRISONE excipients list
DailyMed Link:	LOTRISONE at DailyMed

See drug prices for LOTRISONE

See drug sales revenues for LOTRISONE

Recent Clinical Trials for LOTRISONE

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

Sponsor	Phase
Jilin University	Phase 2

See all LOTRISONE clinical trials

US Patents and Regulatory Information for LOTRISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984		DISCN	Yes	No
Merck Sharp Dohme	LOTRISONE	betamethasone dipropionate; clotrimazole	LOTION;TOPICAL	020010-001	Dec 8, 2000		DISCN	Yes	No

Expired US Patents for LOTRISONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984

International Patents for LOTRISONE

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

Country	Patent Number	Title	Estimated Expiration
Canada	938611	PROCESS FOR THE PREPARATION OF N-TRITYL-IMIDAZOLES
Finland	50877
Sweden	341633

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LOTRISONE

Last updated: July 29, 2025

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Introduction

LOTRISONE, a topical antifungal and corticosteroid combination, represents a significant product within dermatological treatment, particularly for fungal infections complicating inflammatory skin conditions. Developed by Janssen Pharmaceuticals, LOTRISONE combines clotrimazole and betamethasone dipropionate, providing both antifungal and anti-inflammatory benefits. Understanding its market dynamics and financial trajectory involves analyzing its therapeutic positioning, competitive landscape, regulatory environment, and evolving market trends.

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Therapeutic Profile and Market Positioning

LOTRISONE is primarily prescribed for conditions such as tinea corporis and tinea cruris—common fungal skin infections often complicated by inflammation. The combination therapy offers convenience and improved patient compliance, bolstering its adoption in dermatology clinics. First introduced in the early 2000s, it benefited from the widespread occurrence of fungal infections and the need for combination therapies that address coexisting inflammatory symptoms.

Its dual mechanism targeting fungal pathogens and inflammation differentiates it from monotherapies, reinforcing its position as a premium topical treatment. However, its market share is constrained by the availability of generics and alternative treatments, especially in cost-sensitive markets.

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Market Dynamics

1. Competitive Landscape

The global antifungal market, projected to reach USD 15.55 billion by 2027 with a CAGR of approximately 4.8% (Grand View Research, 2022), features several key players offering monotherapies and combination products. While clotrimazole monotherapy is widely available as an over-the-counter (OTC) product, prescription formulations like LOTRISONE target moderate to severe infections needing corticosteroids.

Recent market entry of generic corticosteroid-antifungal combinations has intensified price competition, reducing the premium that brand-name formulations like LOTRISONE could command. Additionally, the rise of alternative treatments, such as topical terbinafine and other azoles, has made the market more fragmented.

2. Regulatory and Reimbursement Factors

Regulatory approval pathways for combination drugs vary, affecting market access. In the U.S., LOTRISONE benefits from FDA approval and reimbursement coverage, though insurance constraints often favor generics. The patent expiry in some jurisdictions diminishes the drug's exclusivity, facilitating generic competition.

Reimbursement policies heavily influence prescriber preference and patient affordability. In developed markets, insurance coverage sustains demand, but in emerging markets, low-priced generics dominate, challenging branded products.

3. Prescriber and Patient Trends

The shift toward step-down therapy and use of topical antifungals without corticosteroids in uncomplicated cases has tempered growth for combination products like LOTRISONE. Nevertheless, in cases of inflammatory fungal skin infections, clinicians favor formulations that address multiple pathologies simultaneously.

Moreover, increasing awareness regarding the potential adverse effects of corticosteroids—such as skin atrophy—has led to more cautious prescribing, potentially restraining market growth.

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Financial Trajectory and Revenue Outlook

1. Revenue Trends

While proprietary and branded formulations like LOTRISONE historically enjoyed premium pricing, market share erosion due to generics has driven revenues downward. Data from industry sources suggest that the global dermatological topical corticosteroid market has seen a CAGR of approximately 3.2% between 2015-2020, with growth driven by new product development and emerging markets.

In the context of LOTRISONE, its revenues have likely plateaued or declined gradually in mature markets due to patent expirations and generic competition. Nonetheless, steady demand persists in regions where dermatologists prefer combination therapy for complex infections.

2. Emerging Market Potential

Emerging economies such as India, Brazil, and Southeast Asian countries present growth opportunities owing to the high prevalence of fungal infections and increasing healthcare access. Generic manufacturers are actively expanding in these regions, often offering low-cost alternatives. For LOTRISONE’s parent company, strategic partnerships and localized formulations could sustain revenue streams.

3. R&D and Lifecycle Management

To extend the product’s lifecycle, pharmaceutical companies are exploring reformulations (e.g., liposomal or foam versions), combination with other dermatological agents, and new indications. However, such initiatives require significant investment and regulatory approvals, impacting the financial trajectory in the short term.

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Future Market Trends

• Saturation and Shift Toward Monotherapies: As clinicians prefer streamlined therapies, the growth of combination corticosteroid-antifungal products may slow, favoring monotherapy options unless specific complex cases justify their use.

• Biological Alternatives: Advances in biologics for inflammatory skin diseases could indirectly influence the demand for topical corticosteroids, including LOTRISONE.

• Digital and Teledermatology: Telemedicine adoption accelerates diagnosis and prescription patterns, potentially affecting brand-specific prescribing.

• Regulatory Reforms: Stricter regulations on corticosteroid use limit prescriptions, impacting product sales.

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Key Challenges and Opportunities

Challenges:

• Patent Expiration and Generic Competition: Erode market exclusivity and profitability.
• Safety Concerns: Risks associated with corticosteroids influence prescribing behaviors.
• Market Saturation: Limited scope for significant growth in mature markets.

Opportunities:

• Expansion into Emerging Markets: Tapping into high-prevalence regions with affordable generics.
• Innovative Formulations: Developing novel delivery systems or combination therapies with better safety profiles.
• Targeted Indications: Exploring indications beyond fungal skin infections, such as inflammatory dermatoses.

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Conclusion

The financial trajectory of LOTRISONE is characterized by mature product dynamics, declining revenues in developed markets due to generics and safety concerns, and growth prospects in emerging economies. Its future depends on strategic lifecycle management, expanding indications, and navigating regulatory and competitive pressures. For stakeholders, focusing on regional market penetration, innovative formulations, and clinical differentiation remains key.

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Key Takeaways

• Market Position: LOTRISONE occupies a niche for complex fungal infections necessitating anti-inflammatory treatment, but faces intense generic competition.
• Revenue Trends: Revenues are declining in mature markets primarily due to patent expiration and generic infiltration.
• Growth Opportunities: Emerging markets, reformulation strategies, and new indications offer viable pathways for sustained growth.
• Regulatory and Safety Impact: Evolving regulations and safety profiles influence prescribing patterns and market dynamics.
• Strategic Focus: Maximizing lifecycle value requires balancing cost-competitiveness with innovation and regional expansion.

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FAQs

1. What is the primary therapeutic advantage of LOTRISONE?
Its combination of antifungal and corticosteroid components allows simultaneous treatment of fungal infections and associated inflammation, improving clinical outcomes and patient compliance.

2. How does patent expiry affect LOTRISONE's market position?
Patent expiry introduces generic competition, reducing pricing power and eroding market share for the branded product in matured markets.

3. Are there safety concerns limiting LOTRISONE’s use?
Yes. The corticosteroid component raises concerns about skin atrophy, HPA axis suppression, and other corticosteroid-related adverse effects, influencing prescriber choices.

4. What markets offer growth potential for LOTRISONE?
Emerging economies with high fungal infection prevalence and less price-sensitive healthcare systems present significant growth opportunities.

5. How is the future of combination topical antifungals evolving?
Clinicians are increasingly favoring monotherapies for uncomplicated cases, but combination products like LOTRISONE remain relevant for complex infections requiring multi-faceted therapy.

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Sources

[1] Grand View Research. "Antifungal Drugs Market Size, Share & Trends Analysis Report." 2022.