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Last Updated: December 22, 2024

ESKATA Drug Patent Profile


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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

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Summary for ESKATA
International Patents:18
US Patents:5
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 155
Patent Applications: 2,195
What excipients (inactive ingredients) are in ESKATA?ESKATA excipients list
DailyMed Link:ESKATA at DailyMed
Drug patent expirations by year for ESKATA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ESKATA
Generic Entry Date for ESKATA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ESKATA is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Aclaris ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305-001 Dec 14, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Aclaris ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305-001 Dec 14, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aclaris ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305-001 Dec 14, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Aclaris ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305-001 Dec 14, 2017 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 15249841
Patent: Peroxide formulations and methods and applicators for using the same
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2016024630
Patent: composição tópica, uso de uma composição tópica e aplicador
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 46568
Patent: FORMULES DE PEROXYDE ET PROCEDES ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Estimated Expiration: ⤷  Subscribe

China

Patent: 6659643
Patent: 过氧化物制剂及使用过氧化物制剂的方法和施加器 (Peroxide formulations and methods and applicators for using the same)
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 34061
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 34061
Patent: FORMULES DE PEROXYDE ET PROCÉDÉS ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 8462
Patent: פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 22217
Estimated Expiration: ⤷  Subscribe

Patent: 17513907
Patent: 過酸化物製剤ならびにその使用のための方法および塗布器
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 16013826
Patent: FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.)
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 34061
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 34061
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 11662
Patent: ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ (PEROXIDE COMPOSITIONS AND METHODS AND APPLICATORS FOR USE THEREOF)
Estimated Expiration: ⤷  Subscribe

Patent: 16145236
Patent: ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ, И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201608775X
Patent: PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 170029413
Patent: 과산화물 제제 및 이를 사용하기 위한 방법 및 어플리케이터 (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 28711
Estimated Expiration: ⤷  Subscribe

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
Japan 2017513907 過酸化物製剤ならびにその使用のための方法および塗布器 ⤷  Subscribe
Singapore 167656 COMPOSITION FOR THE TREATMENT OF SKIN CONDITIONS ⤷  Subscribe
Israel 248462 פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same) ⤷  Subscribe
Russian Federation 2016145236 ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ, И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ ⤷  Subscribe
Spain 2828711 ⤷  Subscribe
Australia 2015249841 Peroxide formulations and methods and applicators for using the same ⤷  Subscribe
Mexico 2016013826 FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ESKATA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3106463 2090009-8 Sweden ⤷  Subscribe PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
2523731 CA 2020 00025 Denmark ⤷  Subscribe PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
0281459 35/1998 Austria ⤷  Subscribe PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
2523731 2020/020 Ireland ⤷  Subscribe PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113
3106463 CR 2020 00013 Denmark ⤷  Subscribe PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
1968948 LUC00234 Luxembourg ⤷  Subscribe PRODUCT NAME: SELUMETINIB (INCLUANT TOUS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER LE SULFATE D'HYDROGENE), SES ESTERS, SOLVATES ET ENANTIOMERES); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
3106463 2020/009 Ireland ⤷  Subscribe PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REGISTRATION NO/DATE: EU/1/19/1385 20190923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ESKATA Market Analysis and Financial Projection Experimental

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.

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