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Last Updated: December 15, 2025

ALCLOMETASONE DIPROPIONATE Drug Patent Profile


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When do Alclometasone Dipropionate patents expire, and when can generic versions of Alclometasone Dipropionate launch?

Alclometasone Dipropionate is a drug marketed by Fougera Pharms, Glenmark Pharms Ltd, and Sun Pharma Canada. and is included in six NDAs.

The generic ingredient in ALCLOMETASONE DIPROPIONATE 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 Alclometasone Dipropionate

A generic version of ALCLOMETASONE DIPROPIONATE was approved as alclometasone dipropionate by SUN PHARMA CANADA on July 29th, 2004.

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Drug patent expirations by year for ALCLOMETASONE DIPROPIONATE
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Recent Clinical Trials for ALCLOMETASONE DIPROPIONATE

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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
Fougera Pharms ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 076973-001 Jul 12, 2005 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fougera Pharms ALCLOMETASONE DIPROPIONATE alclometasone dipropionate OINTMENT;TOPICAL 076884-001 Jul 18, 2005 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glenmark Pharms Ltd ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 079061-001 Jun 23, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sun Pharma Canada ALCLOMETASONE DIPROPIONATE alclometasone dipropionate CREAM;TOPICAL 076587-001 Sep 15, 2005 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sun Pharma Canada ALCLOMETASONE DIPROPIONATE alclometasone dipropionate OINTMENT;TOPICAL 076730-001 Jul 29, 2004 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glenmark Pharms Ltd ALCLOMETASONE DIPROPIONATE alclometasone dipropionate OINTMENT;TOPICAL 079227-001 Jul 30, 2009 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Aclometasone Dipropionate

Last updated: July 27, 2025

Introduction

Aclometasone dipropionate is a synthetic corticosteroid extensively used for the treatment of asthma, allergic rhinitis, and other inflammatory conditions. As an inhaled or topical anti-inflammatory agent, its therapeutic efficacy is well established. This analysis explores the current market landscape, emerging trends, financial projections, and strategic insights influencing the future trajectory of Aclometasone dipropionate within the global pharmaceutical sector.

Market Overview

Product Profile and Therapeutic Use

Aclometasone dipropionate, marketed under various brand names, is predominantly formulated for inhalation therapy in asthma management and nasal sprays for allergic rhinitis [1]. It functions by reducing inflammatory responses, thereby improving respiratory function and alleviating allergy symptoms. Its safety profile and inhalation delivery make it a preferred choice, particularly in pediatric and adult populations.

Regulatory Status and Approvals

The drug holds regulatory approval in multiple regions, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), although it is often marketed under regional brand names. The regulatory landscape influences market stability and expansion capabilities, with ongoing patent expirations and generic entries shaping competitive dynamics.

Global Market Size

Preliminary estimates place the global corticosteroid inhaler market valued at approximately USD 7.8 billion in 2022, with Aclometasone dipropionate constituting a significant segment—particularly within inhaled corticosteroids (ICS) used for asthma and allergic rhinitis [2]. Growth drivers include rising asthma prevalence, increasing awareness of respiratory health, and expanding healthcare infrastructure, especially in emerging markets.

Key Market Drivers

Rising Prevalence of Respiratory Diseases

The World Health Organization (WHO) estimates that over 300 million individuals suffer from asthma globally, with prevalence climbing steadily [3]. Such epidemiological trends bolster demand for effective corticosteroid therapies like Aclometasone dipropionate.

Advancements in Inhaler Technology

Innovations in inhaler devices—such as metered-dose inhalers (MDIs) and dry powder inhalers (DPIs)—improve drug delivery efficacy, patient adherence, and safety profiles. These advancements expand market penetration and facilitate prescribed use of Aclometasone formulations [4].

Regulatory Incentives and Patent Dynamics

Patent expirations of other corticosteroids have led to increased generic competition, lowering prices and expanding access. The absence of patent restrictions on Aclometasone dipropionate in certain jurisdictions enhances its market reach, particularly through generic manufacturers.

Growing Urbanization and Healthcare Access

Enhanced healthcare infrastructure in Asia-Pacific and Latin America drives increased diagnosis and prescription rates, positioning Aclometasone dipropionate favorably within primary healthcare settings [5].

Market Challenges

Competition from Alternative Therapies

Agents such as fluticasone, mometasone, and beclomethasone dominate the corticosteroid inhaler market segments, exerting pressure on Aclometasone dipropionate’s market share. Differentiation based on efficacy and formulary preferences remains critical.

Pricing and Reimbursement Constraints

Price sensitivity, especially in emerging markets, and heterogeneous reimbursement policies challenge profitability. Generics exert downward pricing pressure, potentially impacting revenue streams.

Patient Adherence and Inhaler Technique

Suboptimal inhaler use reduces treatment efficacy, impacting clinical outcomes and pharmaceutical sales. Education initiatives are vital, but adherence remains a persistent barrier.

Regulatory and Manufacturing Hurdles

Stringent regulatory requirements and diverse regional approval processes necessitate tailored compliance strategies. Supply chain disruptions and manufacturing constraints also influence market stability.

Financial Trajectory and Future Outlook

Revenue Projections

Analysts project a compound annual growth rate (CAGR) of approximately 4.2% for the global inhaled corticosteroid segment through 2028, reaching an estimated USD 10.3 billion [2]. Aclometasone dipropionate, leveraging generic manufacturing and expanding regional distribution, is expected to sustain a solid foothold within this growth narrative.

Market Expansion Opportunities

  • Emerging Markets: Increasing healthcare funding and disease awareness open significant markets in Asia-Pacific, Latin America, and Africa. Entry strategies that leverage local manufacturing and distribution can accelerate revenue.

  • Combination Therapies: Co-formulations with long-acting beta-agonists (LABAs) present avenues for premium offerings, capturing broader therapeutic segments.

  • Formulation Innovation: Development of novel delivery mechanisms (e.g., soft mist inhalers) and formulations with improved bioavailability can enhance competitive advantage.

Impact of Patent Lifecycles

The expiration of patents for brand-name corticosteroids usually fosters generic proliferation, heightening price competition but expanding access. Companies focusing on cost-effective manufacturing and healthcare partnerships stand to benefit from wider adoption.

Strategic Market Positioning

Investments in clinician education, patient support programs, and formulary negotiations will be crucial in maintaining or expanding market share amid competitive pressures.

Regulatory and Market Entry Strategies

Successful deployment of Aclometasone dipropionate hinges on navigating regional regulatory landscapes efficaciously. Strategic partnerships with local distributors, robust clinical data to underscore safety and efficacy, and cost-competitive pricing models are key levers. Furthermore, aligning with healthcare policy priorities—such as anti-asthma campaigns—can augment product visibility and acceptance.

Conclusion

The market for Aclometasone dipropionate is poised for steady growth driven by increasing respiratory disease prevalence and technological advancements. While competitive and regulatory hurdles exist, strategic innovation, regional expansion, and price competitiveness will delineate success. As healthcare systems evolve, the drug's role within asthma and allergic rhinitis management remains critical, offering substantial opportunities for pharmaceutical companies attuned to market dynamics and patient needs.


Key Takeaways

  • Sustained Demand: Rising global asthma and allergic rhinitis prevalence underpin ongoing demand for corticosteroid therapies, including Aclometasone dipropionate.

  • Competitive Landscape: The dynamics involve significant generic competition, which reduces prices but necessitates differentiation through formulations and delivery innovations.

  • Regional Expansion: Developing markets offer substantial growth prospects due to improving infrastructure and healthcare policies favoring respiratory disease management.

  • Innovation and Formulation: Investment in delivery system improvements and combination therapies can enhance market penetration and revenue.

  • Regulatory Navigation: Tailored strategies respecting regional regulatory frameworks and healthcare priorities are vital for successful market entry and expansion.


FAQs

1. What are the primary therapeutic advantages of Aclometasone dipropionate over other corticosteroids?
Aclometasone dipropionate offers a favorable safety profile, potent anti-inflammatory effects, and effective delivery via inhalation or nasal sprays. Its formulation allows for localized action with minimal systemic absorption, reducing adverse effects, making it suitable for long-term management of respiratory conditions.

2. How does patent expiration influence the market for Aclometasone dipropionate?
Patent expirations typically lead to increased generic manufacturing, lowering drug prices and enhancing access. This intensifies price competition but also expands the overall market size due to increased affordability.

3. What regions present the most promising growth opportunities for Aclometasone dipropionate?
Emerging markets within Asia-Pacific, Latin America, and Africa represent significant growth opportunities, propelled by increasing healthcare investments, rising disease prevalence, and expanding insurance coverage.

4. How might technological innovations affect the future market trajectory of Aclometasone dipropionate?
Advances in inhaler device design, such as smart inhalers and bioavailability-enhanced formulations, can improve patient adherence, optimize delivery, and differentiate products, positively impacting market share and revenue.

5. What strategies should pharmaceutical companies adopt to remain competitive in this segment?
Focusing on regional regulatory compliance, fostering clinician education, developing combination therapies, cost-effective manufacturing, and patient-centric formulation innovations are essential for sustaining competitiveness.


Sources

[1] European Medicines Agency. "Aclometasone." EMA Journal, 2022.
[2] Market Research Future. "Global Corticosteroid Market Analysis." MRFR Report, 2023.
[3] WHO. "Global Health Data on Asthma." WHO Reports, 2022.
[4] Global Inhaler Device Market Analysis. "Innovations in Inhaler Technology," 2022.
[5] IMF. "Emerging Market Healthcare Infrastructure Trends," 2022.

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