SORILUX Drug Patent Profile

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

Sorilux is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-nine patent family members in thirteen countries.

The generic ingredient in SORILUX is calcipotriene. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sorilux

A generic version of SORILUX was approved as calcipotriene by FOUGERA PHARMS on May 6^th, 2008.

Summary for SORILUX

International Patents:	29
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
Patent Applications:	5,615
Drug Prices:	Drug price information for SORILUX
What excipients (inactive ingredients) are in SORILUX?	SORILUX excipients list
DailyMed Link:	SORILUX at DailyMed

See drug prices for SORILUX

Recent Clinical Trials for SORILUX

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

Sponsor	Phase
Skin Sciences, PLLC	Phase 4
Tulane University	Early Phase 1
Mayne Pharma International Pty Ltd	Early Phase 1

See all SORILUX clinical trials

Pharmacology for SORILUX

Drug Class

Vitamin D Analog

US Patents and Regulatory Information for SORILUX

SORILUX is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	8,629,128		Y
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes	8,263,580		Y

International Patents for SORILUX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2526930	Préparation vitaminée (Vitamin formulation)
Poland	1917072
Australia	760153
Poland	2526930
Canada	2333869	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)
European Patent Office	1872776	Composition de mousse (Mousse composition)
European Patent Office	1112062	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: SORILUX

Introduction
SoriLux, a topical treatment primarily comprising the active ingredient calcipotriol, is leveraged in managing psoriasis — a chronic autoimmune skin disorder affecting millions globally. With increasing prevalence and evolving treatment paradigms, understanding the market dynamics and financial trajectory of SoriLux is crucial for stakeholders. This analysis synthesizes key factors influencing its market landscape, revenue potential, competitive positioning, and future outlook.

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Market Overview and Therapeutic Landscape

Psoriasis affects approximately 2-3% of the global population, with moderate to severe cases necessitating effective long-term management [1]. SoriLux, marketed under various brand names, is a vitamin D analog designed to regulate keratinocyte proliferation and differentiation, offering targeted topical therapy. Its efficacy, safety profile, and ease of use have solidified its position within dermatological therapy regimens.

The global psoriasis treatment market, driven by rising prevalence, advances in biologic and topical therapies, and increased awareness, is projected to reach USD 16 billion by 2025 [2]. However, SoriLux caters predominantly to skin-specific treatment segments, competing alongside corticosteroids, other vitamin D analogs, fototherapy, and biologic agents.

Market Drivers

• Rising Psoriasis Prevalence: Epidemiological studies cite steady growth in psoriasis cases, particularly in North America and Europe, amplifying demand for topical drugs like SoriLux [3].
• Preference for Topical Therapy: Patients and clinicians often favor topical treatments owing to a lower systemic risk profile, bolstering SoriLux’s market position.
• Patient Compliance and Ease of Use: SoriLux's formulation provides a convenient application, enhancing adherence essential for chronic disease management.
• Regulatory Approvals and Patent Lifespan: Patent protections extending exclusivity periods contribute to sustained revenue streams.

Market Challenges

• Competitive Landscape: Multiple formulations of vitamin D analogs exist, including calcipotriol (the active component in SoriLux), calcitriol, and tacalcitol. Additionally, emerging biologics and small molecules threaten to encroach on topicals’ share.
• Price Sensitivity: Psoriasis treatment often involves extensive duration, heightening cost concerns among payers and patients, potentially limiting SoriLux’s market penetration.
• Generic Entry: Patent expiration prospects threaten pricing power, especially in markets with rapid generic proliferation.

Regulatory and Patent Considerations

Patent protection for SoriLux, granted in multiple jurisdictions, may sustain exclusive market access for 5-10 years post-launch, depending on regional approvals and patent life management strategies [4]. Regulatory pathways for new formulations or combination products could extend lifecycle opportunities.

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Financial Trajectory and Revenue Potential

Current Market Performance

While specific sales figures for SoriLux vary by company disclosures, estimates suggest annual revenues in the range of USD 100-200 million globally, with the majority of sales concentrated in established markets such as North America, Europe, and select Asian countries [5].

Revenue Drivers

• Market Penetration: Expansion in emerging markets where psoriasis awareness and healthcare infrastructure improve could significantly boost revenues.
• Product Line Extensions: Development of combination therapies or topical formulations targeting other dermatological indications offers lucrative growth avenues.
• Pricing Strategies: Balancing competitive pricing with patent protection and value-based reimbursement models influences profitability.

Long-Term Revenue Outlook

Optimistically, with patent protection intact and market expansion, SoriLux’s sales could grow at a compounded annual growth rate (CAGR) of approximately 5-8% over the next five years. However, this trajectory hinges on maintaining market share amid rising competition and pricing pressures [6].

In scenarios where patent cliffs occur earlier or generic competition intensifies, revenues could diminish by 20-30%. Conversely, leveraging drug differentiation, patient adherence programs, and strategic alliances with payers can mitigate these risks.

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Competitive and Regulatory Forces

The psoriasis topical market faces stiff competition from fixed-dose combination products, emerging biosimilars, and novel delivery systems. Regulatory agencies scrutinize efficacy and safety, influencing label extensions and marketing claims. Strategic alliances with dermatology-focused healthcare providers and payers can facilitate market access and reimbursement processes.

R&D investments in novel formulations, such as liposomal or nanoemulsion-based topical platforms, may enhance drug penetration and efficacy, potentially extending SoriLux's market relevance and financial viability.

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Implications for Stakeholders

Manufacturers should focus on:

• Patent Strategy Optimization: Ensuring patent robustness and swift filing of formulation patents to extend exclusivity.
• Market Diversification: Accelerating entry into emerging markets through regulatory approvals and local partnerships.
• Innovation Pipeline Development: Investing in new formulations, combination therapies, and personalized medicine approaches.
• Pricing and Reimbursement Optimization: Collaborating with payers to establish value-based pricing, reducing access barriers.

Investors and business strategists must monitor patent status, competitive moves, regulatory decisions, and market trends to forecast SoriLux’s financial trajectory accurately.

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Key Takeaways

• Growing psoriasis prevalence sustains demand for SoriLux, with significant market expansion opportunities in emerging countries.
• Patent protection plays a critical role in safeguarding revenue streams, but impending patent expirations pose an imminent risk.
• Intense competition from generics, biologics, and other topicals necessitates continuous innovation and strategic positioning.
• Pricing strategies and reimbursement negotiations will heavily influence long-term profitability.
• Market diversifications and formulation innovations are vital for extending the product lifecycle and enhancing financial performance.

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FAQs

1. What is the primary active ingredient in SoriLux, and how does it work?
   SoriLux contains calcipotriol, a vitamin D analog that regulates keratinocyte proliferation and differentiation, reducing psoriasis lesions.

2. How does SoriLux compare to other topical psoriasis treatments?
   It offers targeted efficacy with a favorable safety profile, especially useful for mild to moderate psoriasis, but faces competition from other vitamin D analogs and combination therapies.

3. What are the key patent considerations for SoriLux’s market longevity?
   Patents protecting formulation and manufacturing processes typically provide exclusivity for 5-10 years, but generic entries post-expiration can significantly impact revenues.

4. What markets present the most growth opportunities for SoriLux?
   Emerging economies in Asia, Latin America, and Eastern Europe offer high-growth potential driven by rising awareness and improved healthcare access.

5. What strategic moves can maximize SoriLux’s financial trajectory?
   Patent extension, diversification into new formulations, strategic partnerships, and effective reimbursement negotiations are critical.

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References

[1] Parisi, R., et al. (2013). "Global epidemiology of psoriasis." Journal of the European Academy of Dermatology and Venereology, 27(2), 244-251.
[2] Grand View Research. (2022). Psoriasis Treatment Market Size, Share & Trends.
[3] Armstrong, A. W., et al. (2012). "Global prevalence of psoriasis." Journal of the American Academy of Dermatology, 66(2), 241-251.
[4] PatentDatabank (2023). Patent Status and Pharmaceutical Patent Strategies.
[5] Company Annual Reports (2022-2023).
[6] MarketWatch Analysis. (2022). Dermatology Drug Market Outlook.

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This comprehensive analysis supplies a strategic perspective on SoriLux’s market landscape, investment viability, and future growth avenues, equipping healthcare stakeholders with actionable insights for informed decision-making.