Details for Patent: 9,814,690

Summary for Patent: 9,814,690

Title:	Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt
Abstract:	Dermatological/cosmetic compositions suited for preventing or treating cell differentiation and/or proliferation and/or keratinization disorders, including preventing or treating common acne, comprise, in a physiologically acceptable medium, (i) at least one dispersed retinoid, (ii) dispersed benzoyl peroxide, in free or encapsulated form, and (iii) at least one pH-independent gelling agent, selected from the group consisting of (a) polyacrylamide gelling agents, (b) gelling agents which are acrylic polymers coupled to hydrophobic chains, (c) modified starch gelling agents, and mixture thereof, said composition maintaining good chemical stability of (i) and (ii) without their degradation over time at a temperature of between 4.degree. C. and 40.degree. C.
Inventor(s):	Orsoni; Sandrine (Mandelieu, FR), Willcox; Nathalie (Le Rouret, FR)
Assignee:	Galderma Research & Development (Biot, FR)
Application Number:	12/076,860
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding United States Patent 9,814,690: A Detailed Analysis

Introduction to Adapalene and Benzoyl Peroxide Gel

Adapalene, a third-generation topical retinoid, is widely used in combination with benzoyl peroxide to treat acne vulgaris. The combination of adapalene and benzoyl peroxide is found in products like Epiduo Forte, which is owned by Galderma Laboratories Inc. This article will delve into the specifics of United States Patent 9,814,690, focusing on its scope, claims, and the broader patent landscape.

Overview of United States Patent 9,814,690

Patent Number and Title

• The patent in question is US 9,814,690. This patent is part of the intellectual property portfolio related to the formulation and administration of adapalene and benzoyl peroxide gel.

Filing and Expiration Dates

• The patent was filed and approved as part of the broader intellectual property strategy for Epiduo Forte. It expired on December 23, 2022[2][5].

Scope and Claims of the Patent

Claims and Inventions

• The patent covers specific formulations, methods of administration, and dosage forms of adapalene and benzoyl peroxide gel. These claims are crucial for protecting the proprietary aspects of the drug, including its composition, method of use, and any unique characteristics that differentiate it from generic alternatives[2].

Protection of Formulations

• The patent specifically protects the combination of adapalene and benzoyl peroxide in a gel formulation, which is designed to enhance the efficacy and stability of the active ingredients. This protection extends to the specific concentrations of adapalene (0.3%) and benzoyl peroxide (2.5%) that are commonly used in clinical settings[1].

Patent Landscape and Exclusivity

Patent Family and Related Patents

• US 9,814,690 is part of a larger family of patents related to Epiduo Forte. This family includes multiple patents that cover various aspects of the drug, such as administration methods, dosage forms, and treatment of dermatological disorders. Other notable patents in this family include US 8703820, US 8729127, and US 9381179, all of which have expired as of March 2023[5].

Global Patent Protection

• While US 9,814,690 provides exclusivity within the United States, Epiduo Forte is also protected by patents in multiple other countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[5].

Litigation and Settlements

ANDA Litigation

• The approval of generic versions of adapalene and benzoyl peroxide gel has been subject to litigation under the Hatch-Waxman Act. Companies like Taro Pharmaceuticals U.S.A. Inc. have filed Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, challenging the validity or enforceability of the patents, including US 9,814,690. Litigation was initiated against Taro for infringement of several patents, including this one[2].

Settlements and Generic Launch

• Settlements in ANDA litigation can significantly impact the timing and conditions under which generic versions of the drug can be launched. For example, settlements may include agreements on the date of generic launch or other terms that affect market competition[4].

Implications for Generic Entry

Post-Patent Expiration

• With the expiration of US 9,814,690 and other related patents, the market is now more open to generic competition. Generic manufacturers can now produce and market their own versions of adapalene and benzoyl peroxide gel without infringing on the expired patents[5].

Market Impact

• The expiration of these patents is expected to increase competition in the market, potentially leading to lower prices and greater accessibility of the treatment for patients. This shift can also drive innovation as companies seek to differentiate their products through new formulations or delivery methods[5].

Key Takeaways

• Patent Expiration: US 9,814,690 and related patents have expired, opening the market to generic competition.
• Global Protection: Understanding the global patent landscape is crucial for market entry strategies.
• Litigation: ANDA litigation and settlements play a significant role in determining the timing and terms of generic launches.
• Market Impact: The expiration of these patents is likely to increase competition, reduce prices, and enhance patient access to the treatment.

FAQs

1. What is the primary use of adapalene and benzoyl peroxide gel?

• Adapalene and benzoyl peroxide gel is primarily used to treat acne vulgaris due to its anti-comedogenic, comedolytic, and anti-inflammatory properties.

2. What is the significance of US 9,814,690?

• US 9,814,690 is a patent that protected the specific formulation and administration method of adapalene and benzoyl peroxide gel, ensuring exclusivity for the proprietary product.

3. When did US 9,814,690 expire?

• The patent US 9,814,690 expired on December 23, 2022.

4. How does the expiration of this patent affect the market?

• The expiration of this patent allows for generic competition, potentially leading to lower prices and greater accessibility of the treatment.

5. What other patents are related to Epiduo Forte?

• Other related patents include US 8703820, US 8729127, and US 9381179, all of which have also expired.

Sources

1. DrugBank: Adapalene: Uses, Interactions, Mechanism of Action.
2. FDA: ANDA 209148 ANDA APPROVAL Taro Pharmaceuticals U.S.A. Inc.
3. DrugPatentWatch: Details for Patent: 7112592.
4. JD Supra: ANDA Litigation Settlements - Summer 2021.
5. Pharsight: Epiduo Forte patent expiration.

Drugs Protected by US Patent 9,814,690

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: 9,814,690

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	01 16747	Dec 21, 2001

International Family Members for US Patent 9,814,690

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1458369		CA 2008 00029	Denmark
European Patent Office	1458369		08C0024	France
European Patent Office	1458369		SPC/GB10/005	United Kingdom