ACLOVATE Drug Patent Profile

Which patents cover Aclovate, and when can generic versions of Aclovate launch?

Aclovate is a drug marketed by Fougera Pharms and is included in two NDAs.

The generic ingredient in ACLOVATE is alclometasone dipropionate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aclovate

A generic version of ACLOVATE was approved as alclometasone dipropionate by TARO on July 29^th, 2004.

Summary for ACLOVATE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	3,749
DailyMed Link:	ACLOVATE at DailyMed

US Patents and Regulatory Information for ACLOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	ACLOVATE	alclometasone dipropionate	CREAM;TOPICAL	018707-001	Dec 14, 1982		DISCN	Yes	No
Fougera Pharms	ACLOVATE	alclometasone dipropionate	OINTMENT;TOPICAL	018702-001	Dec 14, 1982		DISCN	Yes	No

Expired US Patents for ACLOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	ACLOVATE	alclometasone dipropionate	CREAM;TOPICAL	018707-001	Dec 14, 1982
Fougera Pharms	ACLOVATE	alclometasone dipropionate	OINTMENT;TOPICAL	018702-001	Dec 14, 1982

International Patents for ACLOVATE

See the table below for patents covering ACLOVATE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	153494
Austria	377566
Finland	773825
New Zealand	186031	3,20-DIOXO-7ALPHA-HALO-4-PREGNENES AND-1,4-PREGNADINES
Hong Kong	584	NOVEL 7-HALO-3,20-DIOXO-1,4-PREGNADIENES AND-4-PREGNENES AND THEIR PREPARATION
South Africa	7707534

ACLOVATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACLOVATE

Introduction to ACLOVATE

ACLOVATE, also known as alclometasone dipropionate, is a synthetic corticosteroid used topically for dermatologic conditions. It is available in cream and ointment forms and is known for its anti-inflammatory, antipruritic, and vasoconstrictive properties[3].

Market Position and Competition

ACLOVATE operates within the broader market of topical corticosteroids, which is a segment of the dermatology treatment market. This market is characterized by a high level of competition, with numerous other topical corticosteroids available, each with varying potencies and indications.

Distribution Channels

The distribution of ACLOVATE, like other dermatological treatments, is primarily through retail pharmacies, hospital pharmacies, and online pharmacies. Retail pharmacies hold a significant market share due to their accessibility, trust, and proximity to healthcare facilities[1].

Regulatory Environment

ACLOVATE is regulated by the FDA, and its use is subject to the guidelines and warnings outlined in its labeling. The FDA has approved ACLOVATE for dermatologic use only, with specific warnings regarding its potential to suppress the hypothalamic-pituitary-adrenal (HPA) axis, particularly in pediatric patients[3].

Financial Performance

While specific financial data for ACLOVATE alone is not readily available, the financial performance of companies that produce similar dermatological treatments can provide insights.

Revenue Streams

Companies involved in the production and distribution of topical corticosteroids generate revenue through sales of these products. For example, Aclaris Therapeutics, a company involved in dermatology treatments, reported total revenue of $2.8 million for the second quarter of 2024, with an increase driven by royalties earned under licensing agreements[2].

Research and Development Expenses

Significant investments are made in research and development (R&D) to enhance and expand treatment options. Aclaris Therapeutics, for instance, reduced its R&D expenses from $47.9 million in the first half of 2023 to $18.6 million in the first half of 2024, reflecting changes in clinical trial activities and drug development costs[2].

General and Administrative Expenses

General and administrative (G&A) expenses also play a crucial role in the financial trajectory of these companies. Aclaris Therapeutics saw a decrease in G&A expenses from $17.1 million to $11.6 million over the same period, primarily due to reductions in compensation-related expenses and other costs[2].

Market Growth Drivers

The market for dermatological treatments, including ACLOVATE, is driven by several factors:

Increasing Prevalence of Dermatological Conditions

The rising incidence of skin conditions and the growing awareness of dermatological health contribute to the demand for treatments like ACLOVATE.

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in regions like North America and Europe, enhance the accessibility and quality of dermatological care, including the use of topical corticosteroids[1].

Regulatory Support

Regulatory support, such as the FDA's Fast Track designation, aids in the rapid development and approval of new treatments, including those for dermatological conditions[1].

Challenges and Limitations

Despite the growth drivers, there are several challenges:

High Treatment Costs

Severe cases of dermatological conditions can result in high treatment costs, which may limit access, especially in regions with inadequate insurance coverage[1].

Side Effects and Safety Concerns

Topical corticosteroids like ACLOVATE can have side effects, such as HPA axis suppression, which requires careful monitoring and management[3].

Strategic Developments and Partnerships

The market is also influenced by strategic developments and partnerships among pharmaceutical companies. For example, partnerships to develop new treatments and acquisitions to expand product portfolios are common strategies to drive innovation and market growth[1].

Regional Analysis

The market for ACLOVATE and similar treatments varies by region:

North America

North America, particularly the U.S., is a key market due to its advanced healthcare infrastructure and significant investments in oncology and dermatology research[1].

Europe and Asia-Pacific

Europe and the Asia-Pacific region also show significant growth, driven by increasing healthcare expenditure and improving healthcare facilities[1].

Key Takeaways

• Market Size and Growth: The broader market for dermatological treatments, including topical corticosteroids like ACLOVATE, is expected to grow significantly, driven by increasing demand and advancements in healthcare.
• Distribution Channels: Retail pharmacies play a dominant role in the distribution of these treatments.
• Regulatory Environment: FDA regulations and guidelines are crucial for the approval and use of ACLOVATE.
• Financial Performance: Companies involved in dermatology treatments face varying financial trajectories, influenced by R&D expenses, G&A costs, and revenue streams.
• Challenges and Limitations: High treatment costs and potential side effects are significant challenges.

FAQs

1. What is ACLOVATE used for?

   • ACLOVATE (alclometasone dipropionate) is used for the treatment of various dermatological conditions due to its anti-inflammatory, antipruritic, and vasoconstrictive properties.

2. What are the common distribution channels for ACLOVATE?

   • ACLOVATE is primarily distributed through retail pharmacies, hospital pharmacies, and online pharmacies.

3. What are the potential side effects of ACLOVATE?

   • Potential side effects include HPA axis suppression, Cushing syndrome, linear growth retardation, and intracranial hypertension, especially in pediatric patients.

4. How does the regulatory environment impact ACLOVATE?

   • The FDA regulates ACLOVATE, and its use is subject to specific guidelines and warnings outlined in its labeling.

5. What drives the market growth for dermatological treatments like ACLOVATE?

   • Market growth is driven by increasing prevalence of dermatological conditions, advancements in healthcare infrastructure, and regulatory support.

Cited Sources

1. Market.us: "Chemotherapy-Induced Acral Erythema Treatment Market Size"
2. GlobeNewswire: "Aclaris Therapeutics Reports Second Quarter 2024 Financial Results and Provides a Corporate Update"
3. FDA: "ACLOVATE (Alcometasone dipropionate) Label"