ESKATA Drug Patent Profile

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

Eskata is a drug marketed by Aclaris and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in ESKATA is hydrogen peroxide. There are fifty-three drug master file entries for this compound. Additional details are available on the hydrogen peroxide profile page.

DrugPatentWatch^® Generic Entry Outlook for Eskata

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ESKATA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	155
What excipients (inactive ingredients) are in ESKATA?	ESKATA excipients list
DailyMed Link:	ESKATA at DailyMed

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

Constraining patent/regulatory exclusivity:

10,098,910

NDA:

209305

Dosage:

SOLUTION;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 ESKATA

ESKATA is protected by five US patents.

This potential generic entry date is based on patent 10,098,910.

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
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,098,910		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,493,103		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,980,983
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,675,639		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,729,720		Y

Expired US Patents for ESKATA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017	7,381,427

International Patents for ESKATA

When does loss-of-exclusivity occur for ESKATA?

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

Poland

Portugal

Russian Federation

Singapore

South Korea

Spain

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 ESKATA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3134061
Singapore	11201608775X	PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME
Germany	60226953
Russian Federation	2711662	ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ (PEROXIDE COMPOSITIONS AND METHODS AND APPLICATORS FOR USE THEREOF)
Israel	248462	פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same)
European Patent Office	3134061	FORMULES DE PEROXYDE ET PROCÉDÉS ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Australia	2015249841	Peroxide formulations and methods and applicators for using the same

Supplementary Protection Certificates for ESKATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	2190048-5	Sweden		PRODUCT NAME: SELUMETINIB HYDROGEN SULFATE, INCLUDING ANY SOLVATES AND ANHYDROUS FORMS THEREOF; REG. NO/DATE: EU/1/21/1552 20210619
1968948	CA 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB, INKLUSIV FARMACEUTISK ACCEPTABLE SALTE (ISAER HYDROGENSULFAT), ESTRE, SOLVATER OG ENANTIOMERE DERAF; REG. NO/DATE: EU/1/21/1552 20210619
2523731	24/2020	Austria		PRODUCT NAME: OSILODROSTAT ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 (MITTEILUNG) 20200113
2523731	20C1023	France		PRODUCT NAME: OSILODROSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
3106463	LUC00150	Luxembourg		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SULFATE DE LAROTRECTINIB, Y COMPRIS L'HYDROGENOSULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	20C1012	France		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SULFATE DE LAROTRECTINIB TEL QUE L'HYDROGENOSULFATE DE LAROTRECTINIB; NAT. REGISTRATION NO/DATE: EU/1/19/1385 20190923; FIRST REGISTRATION: DE - EU/1/19/1385 20190923
2523731	CA 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113

Market Dynamics and Financial Trajectory for Eskata

Introduction

Eskata, a high-concentration hydrogen peroxide formulation, is a topical solution developed by Aclaris Therapeutics for the treatment of raised seborrheic keratoses (SK) in adult patients. This article delves into the market dynamics and financial trajectory of Eskata, highlighting its regulatory approvals, clinical trials, market performance, and financial aspects.

Regulatory Approvals

Eskata received significant regulatory milestones that paved its way into the market. The US Food and Drug Administration (FDA) approved Eskata in December 2017 after accepting the new drug application in May of the same year[1].

International Approvals

In addition to FDA approval, Eskata secured marketing approvals in several European countries, including Finland, Iceland, Netherlands, Norway, Portugal, Spain, Sweden, Czech Republic, and Belgium under the brand name Eskata, and in Austria, France, Germany, Ireland, Italy, and the UK under the brand name Eskeriele[1].

Clinical Trials

The FDA approval was based on two pivotal Phase III clinical trials, SEBK-301 and SEBK-302. These trials involved 937 patients with four target SK lesions across 34 centers in the US. The results showed that patients treated with Eskata achieved significant clearance of SK lesions compared to those receiving a placebo.

Efficacy Outcomes

• In the SEBK-301 study, 4% of patients treated with Eskata achieved clearance of all four target lesions, while in the SEBK-302 study, this figure was 7.8%[1].
• The combined trial results indicated that 51.3% of lesions treated with Eskata were either clear or near clear, compared to 7.3% in the placebo group[1].

Market Performance

Launch and Distribution

Eskata was commercially launched in the US in mid-2018. Aclaris partnered with McKesson to support the distribution and sales of Eskata[1].

Market Reception

Despite its clinical efficacy, Eskata has faced mixed market reception. On Drugs.com, Eskata has an average rating of 1.2 out of 10 from patient reviews, with 100% of reviewers reporting a negative effect[4].

Financial Trajectory

Revenue and Sales

The financial performance of Eskata is closely tied to the overall strategy and market acceptance of Aclaris Therapeutics. While specific financial data for Eskata alone is not readily available, the company's financial reports provide insights into its overall performance.

• Aclaris Therapeutics has reported revenue growth, but the specific contribution of Eskata to this growth is not detailed. However, the partnership with Cipher Pharmaceuticals for Canadian distribution and other European marketing approvals suggest a strategic push to increase revenue[1].

Operating Expenses and Net Income

The financial health of Aclaris Therapeutics, the company behind Eskata, can be inferred from broader financial reports. For instance, companies in the pharmaceutical sector often face significant operating expenses, including research and development, and selling, general, and administrative costs.

• While not specific to Eskata, the financial reports of similar pharmaceutical companies highlight the challenges in maintaining profitability. For example, Esperion, another pharmaceutical company, reported increased revenues but also significant operating expenses and net losses in some periods[2][5].

Side Effects and Patient Compliance

Common Reactions

Eskata's clinical trials showed that the treatment was generally well tolerated, with common reactions including itching, stinging, crusting, swelling, redness, and scaling at the site of application[1].

Patient Satisfaction

Despite the clinical efficacy, patient reviews indicate a high level of dissatisfaction, which could impact market dynamics and patient compliance. The negative reviews highlight the need for better patient education and possibly improvements in the formulation to reduce side effects[4].

Competitive Landscape

Alternatives

Eskata operates in a market where other hydrogen peroxide formulations are available, although these are not specifically approved for treating raised seborrheic keratoses. Alternatives include other topical hydrogen peroxide solutions, which may offer lower costs but lack the specific approval and clinical trial data supporting Eskata's use[4].

Market Growth and Sales Trends

Sales Trajectory

The sales trajectory of pharmaceutical drugs often follows a pattern of initial growth, followed by stabilization or decline as the market becomes saturated or new competitors enter. For Eskata, the initial launch and distribution partnerships suggest an effort to capture market share early.

• The sales performance of similar drugs indicates that peak-year sales may occur several years after approval, depending on market conditions and competition[3].

Key Takeaways

• Regulatory Approvals: Eskata has received FDA and European approvals, marking significant regulatory milestones.
• Clinical Efficacy: Clinical trials demonstrated the efficacy of Eskata in treating raised seborrheic keratoses.
• Market Performance: Despite clinical success, Eskata has faced mixed market reception and patient dissatisfaction.
• Financial Trajectory: The financial performance of Eskata is part of the broader financial health of Aclaris Therapeutics, with challenges in maintaining profitability common in the pharmaceutical sector.
• Competitive Landscape: Eskata competes with other hydrogen peroxide formulations, though it holds specific approvals for treating raised SK.

FAQs

What is Eskata used for?

Eskata is a topical solution used for the treatment of raised seborrheic keratoses (SK) in adult patients.

How was Eskata approved?

Eskata was approved by the US FDA in December 2017 based on results from two pivotal Phase III clinical trials.

What are the common side effects of Eskata?

Common side effects include itching, stinging, crusting, swelling, redness, and scaling at the site of application.

How does Eskata compare to other hydrogen peroxide formulations?

Eskata is specifically approved for treating raised SK, while other hydrogen peroxide formulations may not have this specific approval.

What is the market reception of Eskata?

Eskata has received mixed market reception, with patient reviews indicating a high level of dissatisfaction despite its clinical efficacy.

Sources

1. Clinical Trials Arena: Eskata (hydrogen peroxide) for the Treatment of Raised Seborrheic Keratoses.
2. Esperion: Esperion Reports Third Quarter 2024 Financial Results and.
3. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs.
4. Drugs.com: Eskata Alternatives Compared.
5. Esperion: Esperion Reports First Quarter 2024 Financial Results.