Details for Patent: 10,933,046

Which drugs does patent 10,933,046 protect, and when does it expire?

Patent 10,933,046 protects EPSOLAY and is included in one NDA.

This patent has twelve patent family members in two countries.

Summary for Patent: 10,933,046

Title:	Method for treatment of rosacea in patients aged 65 years and older
Abstract:	A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.
Inventor(s):	Toledano; Ofer (Kfar Saba, IL), Levy-Hacham; Ofra (Ness Ziona, IL), Nov; Ori (Tarum, IL), Ram; Vered (Rehovot, IL)
Assignee:	SOL-GEL TECHNOLOGIES, LTD. (Ness Ziona, IL)
Application Number:	16/794,839
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 10,933,046: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 10,933,046, issued on March 2, 2021, is a significant patent in the field of dermatology, particularly for the treatment of rosacea. This patent is assigned to SOL-GEL TECHNOLOGIES LTD. and was invented by Ofer Toledano, Ofra Levy-Hacham, Ori Nov, and Vered Ram.

Background

Rosacea is a chronic skin condition characterized by inflammation, redness, and the appearance of small, pus-filled bumps on the face. The treatment of rosacea often involves topical and oral medications aimed at reducing symptoms and preventing flare-ups.

Patent Overview

This patent focuses on a method for the treatment of rosacea in patients aged 65 years and older. Here is a detailed breakdown of its scope and claims:

Claims and Scope

Active Ingredient and Formulation

The patent specifies a pharmaceutical composition that includes about 1% to about 10% w/w benzoyl peroxide as the active ingredient. Benzoyl peroxide is known for its antibacterial and anti-inflammatory properties, making it effective in treating acne and rosacea[4].

Pharmaceutically Acceptable Carrier or Excipient

The composition also includes a pharmaceutically acceptable carrier or excipient. This can include various gelling agents, solvents, and other additives that enhance the stability and efficacy of the formulation[1].

Application Regimen

The patent outlines a specific application regimen where the pharmaceutical composition is applied topically to the skin once daily for a period of about 52 weeks. This long-term treatment regimen is designed to achieve a high success rate in reducing rosacea symptoms[2].

Method of Treatment

Topical Application

The method involves topically applying the pharmaceutical composition to the affected skin area. This approach is crucial for targeting the symptoms of rosacea directly and minimizing systemic side effects.

Success Rate

The patent claims a success rate of about 75% in a group of subjects treated with this regimen. This indicates a significant efficacy of the treatment method in managing rosacea symptoms over an extended period[2].

Patent Expiration Dates

The patent is set to expire on February 19, 2040. This provides SOL-GEL TECHNOLOGIES LTD. with exclusive rights to the method and composition described in the patent for nearly two decades[2].

Related Patents and Exclusivities

Other Patents by SOL-GEL TECHNOLOGIES LTD.

SOL-GEL TECHNOLOGIES LTD. has several other patents related to the treatment of rosacea and other skin conditions. These include patents for long-term treatment regimens and compositions for treating rosacea, which complement the scope of Patent 10,933,046[2].

Exclusivity

In addition to patent protection, the FDA may grant exclusivity rights that can run concurrently with the patent. This ensures that the manufacturer has sole marketing rights for the drug, further protecting their intellectual property[2].

Intellectual Property Protection

Patent Claims Coverage

The patent claims are critical in defining the scope of protection. These claims must be carefully analyzed to understand what is protected and what is not. Tools like Claim Coverage Matrix and Claim Charts can help in categorizing and analyzing these claims effectively[3].

Scope Concepts

The patent's scope concepts, such as the use of benzoyl peroxide and the specific application regimen, are key in determining the value and applicability of the patent claims. These concepts help in identifying gaps in current coverage and future design opportunities[3].

Clinical and Market Impact

Efficacy in Older Patients

The patent's focus on patients aged 65 years and older addresses a significant demographic that often experiences rosacea. The efficacy of this treatment in this age group is crucial for improving the quality of life for these patients.

Market Dominance

With exclusive rights to this method and composition, SOL-GEL TECHNOLOGIES LTD. can maintain a strong market position in the treatment of rosacea. This patent, along with related patents and exclusivities, solidifies their intellectual property portfolio in dermatology.

Conclusion

United States Patent 10,933,046 is a pivotal patent in the treatment of rosacea, particularly for older patients. Its specific claims and scope define a highly effective treatment regimen using benzoyl peroxide, ensuring a strong intellectual property position for SOL-GEL TECHNOLOGIES LTD. in the dermatological market.

Key Takeaways

• The patent describes a method for treating rosacea in patients aged 65 years and older using a pharmaceutical composition containing benzoyl peroxide.
• The treatment involves a once-daily topical application for about 52 weeks.
• The patent claims a success rate of about 75% in treated subjects.
• The patent is set to expire on February 19, 2040.
• SOL-GEL TECHNOLOGIES LTD. holds several related patents and exclusivities that enhance their market position.

FAQs

Q: What is the active ingredient in the pharmaceutical composition described in Patent 10,933,046? A: The active ingredient is benzoyl peroxide, used in concentrations of about 1% to about 10% w/w.

Q: How is the pharmaceutical composition applied according to the patent? A: The composition is applied topically to the skin once daily for a period of about 52 weeks.

Q: What is the claimed success rate of this treatment regimen? A: The patent claims a success rate of about 75% in a group of subjects treated with this regimen.

Q: Who are the inventors of this patent? A: The inventors are Ofer Toledano, Ofra Levy-Hacham, Ori Nov, and Vered Ram.

Q: When is the patent set to expire? A: The patent is set to expire on February 19, 2040.

Cited Sources:

1. US10220049B2 - Google Patents
2. Generic Epsolay Availability - Drugs.com
3. Patent Analytics | Intellectual Property Law
4. Benzoyl peroxide: Uses, Interactions, Mechanism of Action - DrugBank

Drugs Protected by US Patent 10,933,046

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	10,933,046		Y			TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER

International Family Members for US Patent 10,933,046

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3130362
Canada	3130437
Canada	3130439