Details for Patent: 8,445,543

Summary for Patent: 8,445,543

Title:	Combinations of adapalene and benzoyl peroxide for treating acne lesions
Abstract:	Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO.
Inventor(s):	Abou-Chacra Vernet; Marie-line (Nice, FR), Gross; Denis (Callian, FR), Loesche; Christian (Valbonne, FR), Poncet; Michel (Mougins, FR)
Assignee:	Galderma Research & Development (Biot, FR)
Application Number:	13/308,413
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,445,543
Patent Claim Types: see list of patent claims	Use; Compound;

United States Patent 8,445,543: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,445,543, titled "Combinations of adapalene and benzoyl peroxide for treating acne lesions," is a significant patent in the field of dermatology, particularly for the treatment of acne. This patent, issued to Galderma Laboratories, L.P., combines two well-known active ingredients to create an effective treatment for acne lesions.

Background

Acne is a common skin condition that affects millions of people worldwide. The combination of adapalene and benzoyl peroxide has been recognized for its efficacy in reducing acne lesions. Adapalene is a retinoid, while benzoyl peroxide is an oxidizing agent, and together they provide a synergistic effect in treating acne.

Patent Overview

Publication and Status

The patent was published on May 21, 2013, and is currently active[1].

Assignee and Inventors

The patent is assigned to Galderma Laboratories, L.P., with several inventors credited for the development of this combination therapy.

Claims

The patent includes multiple claims that define the scope of the invention.

Independent Claims

• The primary independent claim describes a pharmaceutical composition comprising adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide. This composition is formulated to reduce the number of acne lesions[1].

Dependent Claims

• Dependent claims further specify the formulation, including the concentration of adapalene and benzoyl peroxide, the type of pharmaceutical composition (e.g., gel, cream), and the container design (e.g., two compartments for separate storage of the active ingredients)[1].

Scope of the Invention

Active Ingredients

• The patent focuses on the combination of adapalene and benzoyl peroxide. Adapalene is known for its ability to prevent the formation of microcomedones, while benzoyl peroxide helps to reduce the bacterial load on the skin and unclog pores[1].

Pharmaceutical Compositions

• The patent covers various pharmaceutical compositions, including gels, creams, and other topical formulations. These compositions are designed to be stable and effective in treating acne lesions[1].

Container Design

• The patent also describes a unique container design featuring two compartments, each containing one of the active ingredients. This design ensures the stability and efficacy of the formulation by preventing the premature interaction of adapalene and benzoyl peroxide[1].

Patent Landscape

Related Patents

• Other patents related to acne treatments, such as U.S. Patents 8,100,618 and 8,120,362, also owned by Galderma, cover similar formulations and delivery systems. These patents collectively protect the intellectual property of Galderma in the acne treatment market[4].

Patent Expiration

• The patent expiration dates for related patents, such as U.S. Patent 8,100,618, have been tracked. For instance, U.S. Patent 8,100,618 expired on March 4, 2024. This expiration can impact the availability of generic versions of the drug[4].

Litigation and Infringement

• There have been litigation cases involving this patent, such as complaints for patent infringement. These cases highlight the importance of protecting intellectual property in the pharmaceutical industry[5].

Impact on the Pharmaceutical Industry

Innovation and Competition

• The issuance of this patent has driven innovation in acne treatment by encouraging the development of combination therapies. However, it also creates barriers to entry for generic manufacturers, potentially limiting competition until the patent expires[3].

Generic Launch

• The expiration of key patents allows for the launch of generic versions of the drug, which can significantly reduce costs for consumers. For example, the expiration of U.S. Patent 8,100,618 in 2024 could lead to the introduction of generic alternatives to Epiduo, a product that combines adapalene and benzoyl peroxide[4].

Clinical Efficacy

Reduction in Acne Lesions

• Clinical trials have shown that the combination of adapalene and benzoyl peroxide can reduce the total number of acne lesions by 35% to 80%, with a preferred reduction range of 50% to 70%[1].

Synergistic Effect

• The synergistic effect of combining these two active ingredients enhances the therapeutic efficacy compared to using either ingredient alone. This combination is particularly effective in treating moderate to severe acne[1].

Conclusion

United States Patent 8,445,543 is a crucial patent in the dermatological field, particularly for the treatment of acne. It protects a specific combination of adapalene and benzoyl peroxide, which has been clinically proven to be highly effective. Understanding the scope, claims, and patent landscape of this invention is essential for pharmaceutical companies, researchers, and legal professionals involved in the development and commercialization of acne treatments.

Key Takeaways

• The patent combines adapalene and benzoyl peroxide for treating acne lesions.
• It covers various pharmaceutical compositions and container designs.
• The patent is currently active and has been involved in litigation cases.
• The expiration of related patents can lead to the introduction of generic alternatives.
• Clinical trials have shown significant reductions in acne lesions using this combination therapy.

Frequently Asked Questions (FAQs)

What are the active ingredients in the patent US8445543B2?

The active ingredients are adapalene and benzoyl peroxide.

What is the primary claim of the patent?

The primary claim describes a pharmaceutical composition comprising adapalene or a pharmaceutically acceptable salt thereof and benzoyl peroxide.

How does the container design contribute to the efficacy of the formulation?

The container design features two compartments to prevent the premature interaction of adapalene and benzoyl peroxide, ensuring the stability and efficacy of the formulation.

What is the clinical efficacy of the combination therapy?

Clinical trials have shown that the combination can reduce the total number of acne lesions by 35% to 80%, with a preferred reduction range of 50% to 70%.

When do related patents expire, allowing for generic versions?

Related patents, such as U.S. Patent 8,100,618, have expired or are set to expire, allowing for the potential launch of generic alternatives.

Cited Sources:

1. US8445543B2 - Combinations of adapalene and benzoyl peroxide for treating acne lesions - Google Patents
2. IN THE UNITED STATES DISTRICT COURT - RPX Insight
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN
4. Epiduo patent expiration - Pharsight
5. IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN ... - RPX Insight

Drugs Protected by US Patent 8,445,543

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 8,445,543

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	06 52968	Jul 13, 2006

International Family Members for US Patent 8,445,543

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	061989
Australia	2007274288
Brazil	PI0713182
Canada	2656456
China	101541320
Colombia	6150136
Cyprus	1114473