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. Eight 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:	51
Clinical Trials:	5
Patent Applications:	5,462
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
Mayne Pharma International Pty Ltd	Early Phase 1
Tulane University	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			Y
Mayne Pharma	SORILUX	calcipotriene	AEROSOL, FOAM;TOPICAL	022563-001	Oct 6, 2010		RX	Yes	Yes			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	1112062	COMPOSITION DE MOUSSE (MOUSSE COMPOSITION)
Australia	6069299	Mousse composition
Denmark	1112062
Poland	2526930
Spain	2407407
Japan	4603164
Australia	760153

SORILUX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SORILUX

Introduction to SORILUX

SORILUX, a foam formulation of calcipotriene, is a synthetic vitamin D analog approved by the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis of the scalp and body in patients aged 12 years and older. This approval marked a significant milestone for Mayne Pharma, the company behind SORILUX[1][4].

Market Context: Psoriasis Treatment

Psoriasis is a chronic immune system disease affecting approximately 7.5 million Americans each year, with plaque psoriasis being the most common form, affecting about 80% of those with the condition. The global psoriasis market is projected to grow significantly, reaching around $21 billion by 2022, driven by increasing diagnoses and the development of new treatments[1].

Approval and Launch

SORILUX was initially approved by the FDA in 2010 for adult patients and later received approval for adolescent use in May 2019. The approval for adolescents was based on evidence from clinical trials and a follow-on open-label study in patients aged 12 to 17 years[1][4].

Market Reception and Sales Performance

Since its approval, SORILUX has seen strong sales growth. In the 2019 financial year, SORILUX sales increased by 26% compared to the previous year, contributing significantly to the growth of Mayne Pharma's Specialty Brands Division. This division reported a 105% increase in sales and a 113% increase in gross profit, largely due to the performance of SORILUX, LEXETTE, and the DORYX family of products[3].

Competitive Landscape

The psoriasis treatment market is highly competitive, with multiple companies developing or marketing psoriasis medications. Mayne Pharma's products, including SORILUX and LEXETTE, compete with offerings from companies like Dermavant, Regeneron, Sanofi, AbbVie, Johnson & Johnson, and Novartis. The topical corticosteroid market for psoriasis in the U.S., where SORILUX operates, was valued at around $600 million when LEXETTE was launched[1].

Product Differentiation and Market Position

SORILUX stands out due to its foam delivery platform, which is preferred by dermatologists for its ease of application, lack of greasiness, and stickiness, especially in hair-bearing areas and under clothing. This formulation makes it a more user-friendly option compared to traditional topical treatments[1][4].

Financial Impact on Mayne Pharma

The approval and successful launch of SORILUX have positively impacted Mayne Pharma's financial performance. In the 2019 financial year, the company reported revenue of $525 million, with the Specialty Brands Division, which includes SORILUX, contributing significantly to this figure. Despite overall revenue being down 1% compared to the previous year, the gross profit for the Specialty Brands Division increased by 113%[3].

Challenges and Future Outlook

Mayne Pharma faced challenges in the 2020 financial year due to the COVID-19 pandemic, which led to a decline in prescribing driven by physician office closures and reduced patient visits. This resulted in a 14% decline in sales for the Specialty Brands Division, which includes SORILUX. However, the company has been optimizing its cost base and restructuring its dermatology sales team to mitigate these impacts[5].

Strategic Investments and Growth Trajectory

Mayne Pharma is actively repositioning its business towards more protectable revenue streams, focusing on dermatology, women’s health, and infectious diseases. The company has made significant strategic investments, including the licensing of a novel oral contraceptive product and the development of rare skin disease treatments. These moves are expected to transform the company's business and growth trajectory over the coming years[3].

Key Metrics and Performance

• Sales Growth: SORILUX sales increased by 26% in the 2019 financial year.
• Revenue Contribution: The Specialty Brands Division, which includes SORILUX, reported a 105% increase in sales and a 113% increase in gross profit in 2019.
• Market Value: The topical corticosteroid market for psoriasis in the U.S. was valued at around $600 million.
• COVID-19 Impact: Sales declined by 14% in the 2020 financial year due to pandemic-related challenges[3][5].

Expert Insights

According to Mayne Pharma's CEO, Scott Richards, "SORILUX is an elegant foam formulation that is marketed by Mayne Pharma’s Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients."[1][4]

Illustrative Statistics

• Global Psoriasis Market: Expected to be worth about $21 billion by 2022[1].
• Psoriasis Prevalence: Affects approximately 7.5 million Americans each year[1].
• Topical Corticosteroid Market: Valued at around $600 million in the U.S.[1].

Conclusion

SORILUX has established itself as a significant player in the psoriasis treatment market, particularly with its approval for adolescent use. Despite facing challenges such as increased competition and the impact of the COVID-19 pandemic, Mayne Pharma's strategic investments and focus on protectable revenue streams position SORILUX for continued growth and market dominance.

Key Takeaways

• SORILUX is approved for treating plaque psoriasis in patients aged 12 years and older.
• The product has seen strong sales growth since its approval.
• The foam delivery platform of SORILUX is highly regarded by dermatologists.
• Mayne Pharma is repositioning its business to focus on more protectable revenue streams.
• The company has faced challenges due to the COVID-19 pandemic but is optimizing its cost base and restructuring its sales team.

Frequently Asked Questions (FAQs)

Q: What is SORILUX used for? A: SORILUX is used for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

Q: When was SORILUX approved for adolescent use? A: SORILUX was approved for adolescent use by the FDA in May 2019.

Q: What is the active ingredient in SORILUX? A: The active ingredient in SORILUX is calcipotriene, a synthetic vitamin D analog.

Q: How does the foam delivery platform of SORILUX benefit patients? A: The foam delivery platform of SORILUX is preferred for its ease of application, lack of greasiness, and stickiness, especially in hair-bearing areas and under clothing.

Q: How has the COVID-19 pandemic impacted SORILUX sales? A: The COVID-19 pandemic led to a decline in prescribing due to physician office closures and reduced patient visits, resulting in a 14% decline in sales for the Specialty Brands Division, which includes SORILUX.

Cited Sources

1. Biospace: Australia's Mayne Pharma Receives FDA Nod for Adolescent Plaque Psoriasis Treatment
2. ASX Announcement: Annual Report 2019 - For personal use only
3. ASX Announcement: ASX Announcement - For personal use only
4. Biospace: FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
5. ASX Announcement: 2020 Annual Report - For personal use only