SOLAGE Drug Patent Profile

Which patents cover Solage, and what generic alternatives are available?

Solage is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in SOLAGE is mequinol; tretinoin. Additional details are available on the mequinol; tretinoin profile page.

Summary for SOLAGE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	140
DailyMed Link:	SOLAGE at DailyMed

US Patents and Regulatory Information for SOLAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999		DISCN	No	No

Expired US Patents for SOLAGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999
Almirall	SOLAGE	mequinol; tretinoin	SOLUTION;TOPICAL	020922-001	Dec 10, 1999

International Patents for SOLAGE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9202942	COMPOSICION SINERGISTA PARA DESPIGMENTACION CUTANEA.
Japan	H0714868
Japan	H03118318	SYNERGISTIC DEPIGMENTATION COMPOSITION FOR SKIN PIGMENTATION
Russian Federation	2270002	СТАБИЛЬНАЯ ПРИ ХРАНЕНИИ ТРЕТИНОИН- И 4-ГИДРОКСИАНИЗОЛСОДЕРЖАЩАЯ ЛОКАЛЬНАЯ КОМПОЗИЦИЯ (TRETINOIN- AND 4-HYDROXYANISOLE-CONTAINING TOPICAL COMPOSITION STABLE IN STORAGE)

SOLAGE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sol-Gel Technologies

Introduction

Sol-Gel Technologies, a company focused on developing and commercializing innovative dermatological treatments, has been making significant strides in the pharmaceutical industry. Here, we will delve into the market dynamics and financial trajectory of Sol-Gel, particularly highlighting its key products and pipeline.

Market Position and Products

Sol-Gel Technologies has a robust portfolio of dermatological treatments, with two of its main products being TWYNEO and EPSOLAY.

TWYNEO and EPSOLAY

• TWYNEO and EPSOLAY are licensed to various partners for global distribution. In 2023, Sol-Gel signed exclusive license agreements with Searchlight Pharma for the Canadian market, which includes upfront payments, regulatory and sales milestones, and royalties ranging from low double-digits to high teens[1][2].
• These products have shown strong commercial potential, with EPSOLAY maintaining its #2 position among branded topical rosacea treatments for Papulopustular Rosacea. The recurring base of prescribers for EPSOLAY increased to nearly 100% in Q2 2023, indicating positive patient experience and effective commercial efforts[1].

Global Expansion

Sol-Gel is aggressively expanding its market reach through strategic partnerships.

European and Global Licensing Agreements

• In July 2024, Sol-Gel signed six initial license agreements covering most European countries and South Africa. Additional agreements are anticipated for Latin America, Australia, New Zealand, South Korea, Spain, Italy, and Portugal. These agreements are expected to provide upfront and regulatory milestone payments of up to $3.7 million and an annual royalty revenue stream starting with approximately $1 million to $2 million in 2026, growing to up to $10 million by 2030[2][5].

Pipeline and Clinical Trials

Sol-Gel's pipeline is rich with promising candidates, particularly in the rare disease segment.

SGT-610 (Patidegib)

• SGT-610, a topically applied patidegib, is a Breakthrough-designated Orphan Drug candidate for the treatment of Gorlin syndrome. It is expected to initiate a pivotal Phase 3 trial in late 2023, targeting a market exceeding $300 million annually. The trial is ongoing, with top-line results anticipated in Q2 2026[1][2][5].
• This product has significant market potential, especially given the recent clinical setback of a competing product, positioning Sol-Gel to be a durable market leader if the Phase 3 program succeeds[1].

SGT-210 (Topical Erlotinib)

• SGT-210, a topical erlotinib, is in a proof-of-concept study for Darier disease, a condition with a market potential estimated between $200 million to $300 million. This study reflects Sol-Gel’s commitment to addressing significant unmet medical needs[2][5].

Financial Performance

Sol-Gel’s financial trajectory has shown notable improvements and strategic management.

Revenue and Licensing

• In the second quarter of 2024, Sol-Gel reported total revenue of $5.4 million, primarily from licensing revenue from partners like Beimei, Galderma, and Searchlight. This is a significant increase from $0.6 million in the same period in 2023[2][5].

Cost Management and Efficiency

• Research and development expenses decreased by $2.9 million in Q2 2024 compared to Q2 2023, due to cost-saving measures and reduced expenses in manufacturing, clinical development, and payroll. General and administrative expenses also decreased by $0.4 million, mainly due to lower professional expenses[2][5].

Net Income and Cash Position

• Sol-Gel reported a net income of $1.9 million for the second quarter of 2024, a significant improvement from a net loss of $6.0 million in the same period in 2023. As of June 30, 2024, the company had a total balance of $30.5 million in cash, cash equivalents, and marketable securities, which is expected to fund cash requirements into the first quarter of 2026[2][5].

Market Potential and Growth Drivers

The market potential for Sol-Gel’s products is substantial, driven by several key factors.

Rare Disease Market

• The rare disease market, particularly for conditions like Gorlin syndrome and Darier disease, offers significant growth opportunities. These markets are often underserved, and innovative treatments can capture substantial market share[1][2].

Global Demand and Awareness

• Increasing global awareness and demand for better treatment options in dermatology are driving the market. Partnerships and licensing agreements are crucial in expanding the reach of Sol-Gel’s products to new territories[1][2].

Regulatory Milestones

• Achieving regulatory milestones and approvals is critical for Sol-Gel’s growth. The company’s ability to secure these milestones will significantly impact its revenue and market position[2][5].

Challenges and Opportunities

While Sol-Gel faces challenges, it also has several opportunities for growth.

Competitive Landscape

• The pharmaceutical industry is highly competitive, but Sol-Gel’s focus on rare diseases and its innovative pipeline position it favorably. The recent clinical setback of a competing product for Gorlin syndrome presents an opportunity for Sol-Gel to become a market leader[1].

Funding and Cash Runway

• Sol-Gel continues to explore opportunities for non-dilutive funding to extend its cash runway. The current cash position is expected to fund operations into the first quarter of 2026, but additional funding could further support the company’s growth plans[2][5].

Key Takeaways

• Strong Product Portfolio: Sol-Gel’s products, including TWYNEO and EPSOLAY, have shown strong commercial potential and market acceptance.
• Global Expansion: Strategic licensing agreements are expanding Sol-Gel’s market reach globally.
• Innovative Pipeline: The company’s pipeline, particularly SGT-610 and SGT-210, holds significant market potential in rare diseases.
• Improved Financials: Sol-Gel has reported improved financial results, including increased revenue and reduced expenses.
• Market Growth Drivers: Increasing global demand, regulatory milestones, and a focus on rare diseases are driving Sol-Gel’s growth.

FAQs

What are the main products of Sol-Gel Technologies?

Sol-Gel Technologies' main products include TWYNEO and EPSOLAY, which are dermatological treatments for conditions like acne and rosacea.

What is the status of SGT-610 (patidegib)?

SGT-610 is in a pivotal Phase 3 trial for the treatment of Gorlin syndrome, with top-line results anticipated in Q2 2026. It targets a market exceeding $300 million annually.

How is Sol-Gel expanding its global reach?

Sol-Gel has signed several licensing agreements with key partners to commercialize its products in Europe, South Africa, and other regions, with additional agreements anticipated for Latin America, Australia, and other countries.

What is the current financial position of Sol-Gel Technologies?

As of June 30, 2024, Sol-Gel had a total balance of $30.5 million in cash, cash equivalents, and marketable securities, which is expected to fund cash requirements into the first quarter of 2026.

What are the growth drivers for Sol-Gel’s market potential?

The growth drivers include increasing global demand for better treatment options, regulatory milestones, and a focus on rare diseases like Gorlin syndrome and Darier disease.

Sources

1. Sol-Gel Technologies Reports Second Quarter 2023 Financial Results and Provides Corporate Update. Biospace.
2. UPDATE: Sol-Gel Reports Second Quarter 2024 Financial Results and Provides Corporate Updates. GlobeNewswire.
3. Generic Drug Industry Dynamics. Federal Trade Commission.
4. Narcolepsy Market to Reach US$ 4.68 Billion by 2031, Rising at a CAGR of 9.3%. GlobeNewswire.
5. UPDATE: Sol-Gel Reports Second Quarter 2024 Financial Results and Provides Corporate Updates. Biospace.