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EPSOLAY Drug Patent Profile

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

Epsolay is a drug marketed by Galderma Labs Lp and is included in one NDA. There are ten patents protecting this drug.

This drug has twenty-eight patent family members in eleven countries.

The generic ingredient in EPSOLAY is benzoyl peroxide. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Epsolay

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2028. This may change due to patent challenges or generic licensing.

There is one tentative approval for the generic drug (benzoyl peroxide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for EPSOLAY

International Patents:	28
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Patent Applications:	3,502
Drug Prices:	Drug price information for EPSOLAY
What excipients (inactive ingredients) are in EPSOLAY?	EPSOLAY excipients list
DailyMed Link:	EPSOLAY at DailyMed

See drug prices for EPSOLAY

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

Constraining patent/regulatory exclusivity:

9,868,103

NDA:

214510

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.

US Patents and Regulatory Information for EPSOLAY

EPSOLAY is protected by ten US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,868,103.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	10,945,987
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	9,687,465		Y
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,877,997
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,541,026
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,426,378
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,628,155

International Patents for EPSOLAY

When does loss-of-exclusivity occur for EPSOLAY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPSOLAY around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	015815	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)
Canada	3130441	METHODE DE TRAITEMENT DE SYMPTOMES D'ERYTHEME MODERE A SEVERE CHEZ DES PATIENTS ATTEINTS DE ROSACEE (METHOD FOR TREATMENT OF MODERATE TO SEVERE ERYTHEMA SYMPTOMS IN ROSACEA PATIENTS)
China	101277757	Metal oxide coating of water insoluble ingredients
World Intellectual Property Organization (WIPO)	2020170033
South Korea	101158162
World Intellectual Property Organization (WIPO)	2020170029

Supplementary Protection Certificates for EPSOLAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	SPC/GB11/054	United Kingdom		PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0526708	C300097	Netherlands		PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
1458369	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009

EPSOLAY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EPSOLAY

Introduction

EPSOLAY, a topical cream containing benzoyl peroxide, 5%, is a significant product in the dermatology market, particularly for the treatment of inflammatory lesions of rosacea in adults. Developed by Sol-Gel Technologies and commercialized by Galderma, EPSOLAY has shown promising market dynamics and financial performance. Here, we delve into the key aspects of its market and financial trajectory.

Product Overview

EPSOLAY utilizes a proprietary silica-based microcapsule technology to encapsulate benzoyl peroxide, providing a favorable efficacy and safety profile by slowly releasing the medication over time[3].

Market Adoption and Growth

Since its launch in June 2022, EPSOLAY has demonstrated robust market adoption. Here are some key indicators of its growth:

Prescriber Uptake

EPSOLAY has seen a significant increase in prescriber adoption. By the first quarter of 2023, the recurring base of prescribers for EPSOLAY had increased to 92%, up from 64% in the fourth quarter of 2022. This indicates a high level of prescriber satisfaction and continued use of the product[4].

Prescription Volume

The number of prescriptions written for EPSOLAY has been steadily increasing. In the first quarter of 2023, over 12,000 prescriptions were written, and by the end of 2023, the total prescriptions for the year exceeded 53,000, with over 14,000 prescriptions in the fourth quarter alone[1][4].

Patient Adherence

A targeted patient adherence campaign led to a significant increase in patient refills, with a 34% increase in the fourth quarter of 2023. This suggests that patients are finding the treatment effective and are adhering to the prescribed regimen[1].

Commercial Formulary Coverage

EPSOLAY has made substantial progress in terms of commercial formulary coverage. By the end of 2023, it had achieved commercial formulary coverage for over 12 million covered or better lives, according to MMIT Analytics. This broad coverage has been crucial for its market penetration and accessibility to patients[1].

Financial Performance

Revenue

The financial performance of EPSOLAY is closely tied to the revenue generated through licensing agreements and royalty payments. In 2023, Sol-Gel Technologies reported $1.6 million in revenue, primarily from milestone and royalty payments related to EPSOLAY and another product, TWYNEO. Although this represents a decrease from the $3.9 million in total revenues in 2022, it is largely due to the absence of a significant milestone payment from Galderma in 2023[1].

Royalty Growth

The royalty stream from EPSOLAY has been growing in line with volume growth. This indicates that as the product's sales increase, so do the royalties received by Sol-Gel Technologies. This trend is expected to continue as the product gains further market traction[3].

Licensing Agreements

Sol-Gel Technologies has secured significant licensing agreements that impact the financial trajectory of EPSOLAY. For instance, the licensing agreement with Searchlight Pharma Inc. to commercialize EPSOLAY in Canada includes upfront payments of up to $11 million and additional royalties ranging from low double digits to high teens. These agreements are crucial for expanding the product's reach and generating additional revenue streams[1].

Cash Runway and Financial Flexibility

Despite the challenges in profitability, Sol-Gel Technologies maintains a cash runway that extends into the second half of 2025. This financial flexibility is supported by the company's liquid assets exceeding its short-term obligations, providing a buffer against immediate financial pressures[1][5].

Challenges and Future Outlook

While EPSOLAY has shown strong market dynamics, Sol-Gel Technologies faces profitability challenges, including a negative operating income margin and significant volatility in stock performance. However, the company's financial flexibility and the anticipated growth in international markets could provide resilience and opportunities for future growth[5].

Key Takeaways

• Robust Prescriber Uptake: EPSOLAY has seen a high recurring base of prescribers, indicating strong market acceptance.
• Increasing Prescription Volume: The number of prescriptions written for EPSOLAY has been steadily increasing.
• Improved Patient Adherence: Targeted campaigns have led to significant increases in patient refills.
• Broad Formulary Coverage: EPSOLAY has achieved extensive commercial formulary coverage.
• Growing Royalty Stream: Royalties are increasing in line with volume growth.
• Financial Flexibility: Sol-Gel Technologies maintains a cash runway into the second half of 2025.

FAQs

What is EPSOLAY used for?

EPSOLAY is a topical cream used for the treatment of inflammatory lesions of rosacea in adults. It contains benzoyl peroxide, 5%, encapsulated in silica-based microcapsules[3].

Who commercializes EPSOLAY?

EPSOLAY is commercialized by Galderma, in partnership with Sol-Gel Technologies[1][3].

How has EPSOLAY performed in terms of prescriptions?

By the end of 2023, EPSOLAY had over 53,000 total prescriptions for the year, with over 14,000 prescriptions in the fourth quarter alone[1].

What is the impact of licensing agreements on EPSOLAY's financial performance?

Licensing agreements, such as the one with Searchlight Pharma Inc., provide significant upfront payments and royalties, contributing to the revenue and financial stability of Sol-Gel Technologies[1].

What are the challenges faced by Sol-Gel Technologies regarding EPSOLAY?

Despite strong market dynamics, Sol-Gel Technologies faces profitability challenges, including a negative operating income margin and stock volatility. However, the company's financial flexibility and anticipated international growth offer potential for future resilience[5].

Sources

1. Sol-Gel Reports Full-Year 2023 Financial Results and Corporate Developments - Biospace
2. Galderma delivers record net sales of 2.2 billion USD and 10.8% year-on-year growth - Galderma
3. Sol-Gel Technologies Reports Third Quarter 2022 Financial Results and Provides Corporate Update - GlobeNewswire
4. Sol-Gel Technologies Reports First Quarter 2023 Financial Results and Provides Corporate Update - Sol-Gel IR
5. Sol-Gel inks deals for skin treatment drugs in Europe and South Africa - Investing.com