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 SUN PHARMA CANADA on July 29^th, 2004.

Summary for ACLOVATE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,563
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	4,124,707
Fougera Pharms	ACLOVATE	alclometasone dipropionate	OINTMENT;TOPICAL	018702-001	Dec 14, 1982	4,124,707

International Patents for ACLOVATE

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

Country	Patent Number	Title	Estimated Expiration
Hungary	179784	PROCESS FOR PREPARING NEW 7-HALO-3,20-DIOXO-1,4-PREGNADIENE AND-4-PREGNENE DERIVATIVES
Japan	S604198
South Africa	7707534
Hong Kong	584	NOVEL 7-HALO-3,20-DIOXO-1,4-PREGNADIENES AND-4-PREGNENES AND THEIR PREPARATION
Denmark	153494

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACLOVATE

Last updated: July 30, 2025

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Introduction

ACLOVATE is a topical medication classified as a corticosteroid, primarily used to treat inflammatory skin conditions such as psoriasis, eczema, and dermatitis. Its market trajectory hinges on a confluence of clinical efficacy, regulatory approvals, competitive landscape, and evolving healthcare dynamics. Understanding the current market environment, alongside financial projections, is vital for stakeholders assessing investment, licensing, or competitive positioning.

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Market Overview

The global dermatology market, wherein ACLOVATE is positioned, is robust and expanding. Expected to reach approximately USD 36 billion by 2027, it benefits from increasing prevalence of skin diseases, rising awareness, and advances in topical therapies [1]. Corticosteroids, being a mainstay in dermatological treatment, hold significant market share within this sector.

ACLOVATE's active ingredient, alclometasone dipropionate, is notable for its potent anti-inflammatory properties, offering advantages such as reduced systemic absorption and favorable safety profiles. These attributes underpin its positioning in both prescription and over-the-counter segments.

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Regulatory Milestones and Approvals

Initially approved by the US Food and Drug Administration (FDA) in 1995, ACLOVATE has sustained its market presence through ongoing regulatory compliance and patent protections. As of 2023, patent expirations are imminent or have been achieved in key markets, paving the way for generic entrants, which could significantly impact its revenue streams [2].

Emerging markets present expanding opportunities, but require navigating intricate regulatory requirements. In some jurisdictions, additional formulations or indications are pending approval, which could catalyze market penetration and sales growth.

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Competitive Landscape

ACLOVATE faces competition from other topical corticosteroids across potency spectrums, including brands like Betnovate (betamethasone), Elocon (mometasone), and generic equivalents. The market has shifted towards generics driven by patent expiry, leading to pricing pressures and reduced profit margins for branded products.

Innovative topical therapies, including non-steroidal options and biologics for severe cases, are reshaping treatment paradigms, especially in patients with steroid-resistant conditions or those requiring steroid-sparing strategies.

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Market Drivers

• Increasing Prevalence: Rising cases of psoriasis and eczema globally, driven by urbanization, environmental factors, and improved diagnostic rates.
• Consumer Awareness: Growing awareness campaigns and physician education bolster prescription rates.
• Formulation Advancements: Development of lower-potency and combination formulations enhance safety profiles and compliance.
• Expanding Markets: Emerging economies like India and Brazil offer significant growth potential due to increasing healthcare access and dermatology awareness.

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Market Restraints

• Patent Expiration and Generics: The impending patent cliff may dilute revenues unless countered with new formulations or indications.
• Competitive Pricing Pressures: Cost containment in healthcare systems forces price reductions.
• Patient Preferences: A shift toward steroid-sparing therapies and biologics for severe cases could diminish topical corticosteroids' usage.

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Financial Trajectory

Historical Performance:
Previously, ACLOVATE generated steady revenues, attributed to consistent prescription patterns in established markets. However, as patent protection waned, sales experienced gradual declines, reflecting generic competition’s impact.

Forecasting Future Revenue:
Projections suggest that, absent innovative repositioning, revenues could decline at an annual rate of 10-15% over the next five years due to generics [3]. Conversely, diversification into new formulations, expanded indications, or combination products can mitigate decline and foster growth.

Strategic Opportunities:

• Line Extension: Developing combination creams or lower-potency formulations can sustain market share.
• Geographical Expansion: Targeting underpenetrated markets, especially in Asia and Latin America, can provide revenue uplift.
• Partnerships and Licensing: Collaborations with local manufacturers may accelerate market access and reduce regulatory barriers.

Risk Factors:

• Patent challenges from generic manufacturers.
• Regulatory delays or reclassification impacting market approval timelines.
• Market shifts favoring non-steroidal alternatives.

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Emerging Trends and Innovations

• Personalized Medicine: Genetic profiling could inform tailored topical treatments, expanding ACLOVATE’s potential indications.
• Biologics and Non-Steroidal Approaches: Although currently more relevant in severe psoriasis, these therapies threaten the long-term dominance of topical corticosteroids.
• Digital and Teledermatology: Increased telemedicine adoption can influence prescribing behaviors and market dynamics, potentially favoring brands with digital engagement strategies.

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Conclusion

ACLOVATE’s market and financial prospects are intricately linked to patent exclusivity, regulatory landscapes, and clinical competition. While near-term revenues face downside risks from generics and evolving treatment paradigms, strategic diversification and international expansion could foster renewed growth. Stakeholders should remain vigilant to regulatory developments, patent challenges, and shifting therapeutic preferences that shape its trajectory.

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Key Takeaways

• The global dermatology market offers substantial growth opportunities; however, ACLOVATE faces imminent patent expiration pressures.
• Competition from generics significantly impacts revenue streams, urging innovation, formulation diversification, or market expansion.
• Emerging markets present strategic avenues for growth, especially with tailored regulatory pathways.
• Investing in formulation innovation and geographical diversification can mitigate declining trends and sustain profitability.
• Staying abreast of evolving treatment trends, including biologics and personalized medicine, is vital for future positioning.

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FAQs

1. When is ACLOVATE’s patent expected to expire?
   Patent rights for ACLOVATE are anticipated to expire within the next 1-3 years, after which generic competitors are expected to enter the market.

2. What are the main clinical advantages of ACLOVATE over other corticosteroids?
   ACLOVATE offers potent anti-inflammatory effects with a favorable safety profile and lower systemic absorption, making it suitable for sensitive skin areas.

3. How might upcoming patent expiry impact ACLOVATE’s revenue?
   Patent expiry typically results in increased generic competition, leading to significant revenue declines unless offset by new formulations, indications, or market expansion strategies.

4. Are there ongoing efforts to develop new formulations of ACLOVATE?
   While specific pipeline information is limited, pharmaceutical companies often pursue line extensions or combination products to extend market relevance.

5. What strategies can stakeholders adopt to mitigate risks associated with ACLOVATE’s patent expiration?
   Diversification into new formulations, expansion into emerging markets, strategic licensing, and investing in innovative dermatological therapies can mitigate risks.

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References

[1] Market Research Future, "Dermatology Market - Forecast to 2027," 2022.
[2] U.S. Food and Drug Administration, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
[3] Deloitte, "Pharma Market Outlook 2023," 2023.