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Last Updated: December 22, 2024

Alclometasone dipropionate - Generic Drug Details


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What are the generic drug sources for alclometasone dipropionate and what is the scope of freedom to operate?

Alclometasone dipropionate is the generic ingredient in two branded drugs marketed by Fougera Pharms, Glenmark Pharms Ltd, and Taro, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for alclometasone dipropionate. Three suppliers are listed for this compound.

Summary for alclometasone dipropionate
Drug Prices for alclometasone dipropionate

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Recent Clinical Trials for alclometasone dipropionate

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SponsorPhase
GlaxoSmithKlinePhase 2

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Pharmacology for alclometasone dipropionate

US Patents and Regulatory Information for alclometasone dipropionate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 076587-001 Sep 15, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms ACLOVATE alclometasone dipropionate OINTMENT;TOPICAL 018702-001 Dec 14, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms ACLOVATE alclometasone dipropionate CREAM;TOPICAL 018707-001 Dec 14, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd ALCLOMETASONE DIPROPIONATE alclometasone dipropionate OINTMENT;TOPICAL 079227-001 Jul 30, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 079061-001 Jun 23, 2009 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fougera Pharms ALCLOMETASONE DIPROPIONATE alclometasone dipropionate OINTMENT;TOPICAL 076884-001 Jul 18, 2005 AB RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for alclometasone dipropionate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms ACLOVATE alclometasone dipropionate CREAM;TOPICAL 018707-001 Dec 14, 1982 4,124,707 ⤷  Subscribe
Fougera Pharms ACLOVATE alclometasone dipropionate OINTMENT;TOPICAL 018702-001 Dec 14, 1982 4,124,707 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Alclometasone dipropionate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alclometasone Dipropionate

Introduction

Alclometasone dipropionate, a topical corticosteroid, is widely used in the treatment of various skin conditions, including atopic dermatitis (eczema). Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

The global market for alclometasone dipropionate is influenced by several key factors, including the prevalence of skin conditions, regulatory environments, and the introduction of new therapies.

Prevalence of Skin Conditions

The increasing prevalence of atopic dermatitis and other skin conditions drives the demand for effective treatments like alclometasone dipropionate. According to recent guidelines, the use of topical corticosteroids, including alclometasone dipropionate, is recommended for patients with uncontrolled atopic dermatitis despite moisturizer use[2].

Regulatory Environment

Regulatory approvals and guidelines play a significant role in shaping the market. For instance, the 2023 guidelines for atopic dermatitis recommend the use of alclometasone dipropionate as part of the treatment regimen, which can influence market demand[2].

Emerging Trends

The market is also influenced by emerging trends such as the development of new therapies and the integration of biologics and small molecules. While these new treatments may compete with traditional topical corticosteroids, they also highlight the evolving landscape of dermatological care[2].

Market Segments

The market for alclometasone dipropionate can be segmented into various categories:

Product Forms

Alclometasone dipropionate is available in different forms, including ointments and creams. Each form has its own market dynamics, with ointments often preferred for dry skin and creams for oily skin[2].

Geographic Markets

The global market can be divided into regional segments, each with its own set of market dynamics. For example, the demand in developed countries may be driven by advanced healthcare systems and higher awareness of skin conditions, while in developing countries, affordability and accessibility may be more significant factors[3].

End-Users

The market can also be segmented based on end-users, including hospitals, clinics, and retail pharmacies. Each segment has different purchasing behaviors and requirements, influencing the overall market trajectory.

Financial Trajectory

Revenue Growth

The revenue generated from alclometasone dipropionate sales has been steadily increasing due to the growing demand for effective treatments for skin conditions. Market reports indicate that the global market size is expected to expand, driven by increasing prevalence and improved diagnostic rates[3].

Pricing Dynamics

The financial trajectory is also influenced by pricing dynamics. The cost-effectiveness of alclometasone dipropionate compared to newer, more expensive treatments can affect its market share. For instance, a study on drug price dynamics highlights how price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can impact the cost-effectiveness ratio[4].

Cost-Effectiveness Analysis

Cost-effectiveness analyses are crucial in determining the financial viability of alclometasone dipropionate. These analyses consider factors such as the cost per quality-adjusted life-year (QALY) gained, which can vary significantly based on pricing strategies and market conditions[4].

Competitive Landscape

The competitive landscape for alclometasone dipropionate includes other topical corticosteroids, calcineurin inhibitors, and newer biologic treatments.

Topical Corticosteroids

Other topical corticosteroids, such as betamethasone valerate, compete directly with alclometasone dipropionate. The choice between these treatments often depends on the potency required and the specific skin condition being treated[2].

Calcineurin Inhibitors

Calcineurin inhibitors like pimecrolimus and tacrolimus are also used in the treatment of atopic dermatitis and can compete with alclometasone dipropionate. These inhibitors are recommended for patients with uncontrolled AD refractory to moisturization alone[2].

Biologic Treatments

Biologic treatments, such as dupilumab and tralokinumab, are gaining traction for moderate-to-severe atopic dermatitis. While these treatments are more expensive, they offer alternative options for patients who do not respond to topical treatments[2].

Market Drivers

Increasing Prevalence of Skin Conditions

The rising prevalence of atopic dermatitis and other skin conditions is a significant driver of the market. As more people seek medical attention for these conditions, the demand for effective treatments like alclometasone dipropionate increases.

Advances in Healthcare

Advances in healthcare, including better diagnostic tools and treatment protocols, also drive the market. Improved awareness and education among healthcare providers and patients about the benefits of topical corticosteroids contribute to increased usage[2].

Regulatory Support

Regulatory support and guidelines that recommend the use of alclometasone dipropionate are crucial market drivers. These recommendations help in standardizing treatment protocols and increasing the drug's adoption rate[2].

Market Challenges

Competition from New Therapies

The introduction of new therapies, including biologics and small molecules, poses a challenge to the market for alclometasone dipropionate. These new treatments may offer better efficacy or safety profiles, potentially reducing the market share of traditional topical corticosteroids.

Pricing Pressures

Pricing pressures, particularly in regions with strict healthcare budgets, can affect the market. The cost-effectiveness of alclometasone dipropionate must be continually demonstrated to maintain its position in the market[4].

Side Effects and Safety Concerns

Long-term use of topical corticosteroids, including alclometasone dipropionate, can lead to side effects such as skin atrophy, telangiectasia, and striae. These safety concerns must be addressed through careful prescribing practices and patient education[2].

Future Outlook

Emerging Markets

Emerging markets, particularly in developing countries, offer significant growth opportunities for alclometasone dipropionate. Increasing healthcare spending and improving healthcare infrastructure in these regions can drive demand.

Innovative Delivery Systems

Innovative delivery systems, such as nano-formulations and transdermal patches, could enhance the efficacy and safety of alclometasone dipropionate, making it more competitive in the market.

Combination Therapies

Combination therapies that include alclometasone dipropionate along with other treatments, such as moisturizers and antimicrobials, may become more prevalent, offering comprehensive treatment regimens for complex skin conditions.

Key Takeaways

  • Increasing Demand: The market for alclometasone dipropionate is driven by the increasing prevalence of skin conditions like atopic dermatitis.
  • Regulatory Support: Guidelines and regulatory approvals play a crucial role in shaping market demand.
  • Pricing Dynamics: The financial trajectory is influenced by pricing strategies, including price increases during exclusivity periods and decreases post-exclusivity.
  • Competitive Landscape: The market is competitive, with other topical corticosteroids, calcineurin inhibitors, and biologic treatments.
  • Future Outlook: Emerging markets and innovative delivery systems offer growth opportunities.

FAQs

What is alclometasone dipropionate used for?

Alclometasone dipropionate is a topical corticosteroid used primarily for the treatment of skin conditions such as atopic dermatitis (eczema).

How does the pricing of alclometasone dipropionate affect its market?

Pricing dynamics, including price increases during exclusivity periods and subsequent decreases, can significantly impact the cost-effectiveness and market share of alclometasone dipropionate.

What are the potential side effects of long-term use of alclometasone dipropionate?

Long-term use can lead to side effects such as skin atrophy, telangiectasia, and striae, particularly on sensitive areas.

How does the competitive landscape impact the market for alclometasone dipropionate?

The market is competitive with other topical corticosteroids, calcineurin inhibitors, and biologic treatments, which can affect the market share of alclometasone dipropionate.

What are the future growth opportunities for alclometasone dipropionate?

Emerging markets, innovative delivery systems, and combination therapies offer significant growth opportunities for alclometasone dipropionate.

Sources

  1. Market Research Intellect - Global Alclometasone Dipropionate Reagent Sales Market Size, Scope ...
  2. American Academy of Allergy, Asthma & Immunology - Atopic dermatitis (eczema) guidelines
  3. Gale - Alclometasone Dipropionate Reagent Market Latest trending ...
  4. PubMed - The Influence of US Drug Price Dynamics on Cost-Effectiveness ...

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