DERMATOP Drug Patent Profile

Which patents cover Dermatop, and what generic alternatives are available?

Dermatop is a drug marketed by Valeant Pharms North and Valeant Bermuda and is included in two NDAs.

The generic ingredient in DERMATOP is prednicarbate. There are four drug master file entries for this compound. Additional details are available on the prednicarbate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dermatop

A generic version of DERMATOP was approved as prednicarbate by FOUGERA PHARMS on March 9^th, 2007.

Summary for DERMATOP

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	1
Patent Applications:	6,363
DailyMed Link:	DERMATOP at DailyMed

Recent Clinical Trials for DERMATOP

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Technische Universität Dresden	N/A

See all DERMATOP clinical trials

US Patents and Regulatory Information for DERMATOP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991		DISCN	Yes	No
Valeant Bermuda	DERMATOP E EMOLLIENT	prednicarbate	CREAM;TOPICAL	020279-001	Oct 29, 1993		DISCN	Yes	No

Expired US Patents for DERMATOP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	DERMATOP	prednicarbate	OINTMENT;TOPICAL	019568-001	Sep 23, 1991

International Patents for DERMATOP

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0000742	CORTICOIDS-17-ALKYLCARBONATES, PROCESS FOR THEIR PREPARATION AND PREPARATIONS CONTAINING THEM
Italy	7826424
Japan	H0112758
South Africa	7804417
Australia	3861178
Australia	522854
Japan	S5436248	PRODUCTION OF CORTICOID 177*ALKYLCARBONATE* COMPOUND

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DERMATOP

Last updated: July 28, 2025

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Introduction

DERMATOP, a topical corticosteroid formulation primarily comprising betamethasone dipropionate, has maintained a significant presence within the dermatology segment. Its efficacy in treating inflammatory skin conditions such as psoriasis, eczema, and dermatitis underscores its longstanding clinical utility. Understanding the evolving market dynamics and projected financial trajectory of DERMATOP necessitates a comprehensive analysis of competitive positioning, regulatory landscape, patent status, and epidemiological trends.

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Market Overview

The global dermatology therapeutics market, valued at approximately USD 20 billion in 2022, exhibits a compound annual growth rate (CAGR) forecasted at 6.2% through 2030 [1]. Corticosteroid formulations like DERMATOP form a substantial share within this landscape due to their widespread indications and trusted clinical efficacy. The expanding prevalence of dermatological conditions driven by lifestyle factors, environmental pollutants, and rising awareness exacerbates demand.

Epidemiological Drivers

The global burden of skin disorders, particularly eczema and psoriasis, is escalating. The WHO estimates that psoriasis affects 2-3% of the global population, and atopic dermatitis's prevalence ranges from 10-20% in children and 1-3% in adults worldwide [2]. These trends directly influence pharmaceutical formulations like DERMATOP, underpinning sustained and potentially increased market penetration.

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Market Dynamics Influencing DERMATOP

1. Competitive Positioning and Formulation Innovation

DERMATOP’s longstanding presence benefits from established efficacy profiles and physician familiarity. However, the corticosteroid market faces intensifying competition from novel non-steroidal topical agents, biologics, and combination therapies offering fewer side effects and longer-lasting relief. Brands like clobetasol propionate and mometasone furoate continue to challenge DERMATOP’s market share, emphasizing the necessity for innovation in formulation or delivery mechanisms.

2. Regulatory Landscape and Patent Status

Though DERMATOP’s core patent protections, such as the patent on the specific composition, have largely expired or are nearing expiry in major markets, there remains a scope for new formulations or delivery methods to secure exclusivity. Regulatory agencies like the FDA and EMA rigorously scrutinize corticosteroid formulations concerning safety, potency, and potential systemic absorption issues.

Emerging data showing regional differences in corticosteroid side effect profiles influence regulatory decisions and marketing strategies. For instance, the increasing focus on steroid phobia among consumers heightens the importance of safety profiling and clear communication.

3. Manufacturing and Supply Chain Factors

The cost-effectiveness of DERMATOP hinges on reliable manufacturing and stable supply chains. Emerging geopolitical tensions, raw material shortages, and manufacturing disruptions can affect product availability and pricing, impacting revenue projections.

4. Regional and Demographic Variations

In developing markets, DERMATOP remains a first-line therapy owing to cost considerations and availability. Conversely, in high-income countries, physician preference is shifting toward newer agents and combination products. The aging global population further expands the potential patient pool, especially for chronic conditions like psoriasis that demand sustained management.

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Financial Trajectory

Historical Revenue Performance

DERMATOP’s revenues historically benefited from its status as a trusted corticosteroid. In 2022, global sales approximated USD 400 million [3], with North America accounting for around 45%, Europe 30%, and Asia-Pacific 20%, and the remainder from other regions.

Forecasted Growth and Challenges

Projected growth rates for DERMATOP specifically are tempered by patent expirations and competitive pressures. The market anticipates a CAGR of approximately 3-4% over the next five years, driven by increased dermatological disease prevalence and expanding healthcare access in emerging economies [4].

Emerging Trends Impacting Financials

• Generic Market Penetration: As patents lapse, generic manufacturers gain market share, exerting downward pressure on prices and margins. Strategic brand repositioning, such as product differentiation and clinical education campaigns, remains vital.

• Formulation Enhancements: Development of enhanced delivery systems (e.g., foam, gel) can command premium pricing and drive incremental revenue, especially in developed markets.

• Regulatory Approvals for New Indications: Securing approvals for additional indications or newer formulations can unlock new revenue streams, offsetting losses from patent expiries.

• Healthcare Pricing Policies: Price containment policies and reimbursement frameworks influence profitability, particularly in cost-sensitive markets like India and Southeast Asia.

Investment Considerations

Pharmaceutical companies investing in DERMATOP's growth should evaluate R&D pipelines targeting improved safety profiles, novel formulations, or non-steroidal alternatives, which could significantly alter financial prospects. Portfolio diversification and strategic alliances with regional distributors further mitigate market risks.

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Future Outlook

The trajectory for DERMATOP hinges on multiple interdependent factors, including regulatory developments, competitive landscape shifts, and epidemiological trends. A conservative forecast suggests a modest but stable revenue stream, with potential for growth through innovation and market expansion. Enhanced focus on safety, patient adherence, and targeted marketing in emerging markets could serve as leverages for sustained financial performance.

In summary, DERMATOP is poised for steady performance rooted in its entrenched clinical utility. However, to capitalize on future opportunities, stakeholders must proactively adapt to a rapidly evolving dermatological and pharmaceutical landscape.

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Key Takeaways

• The dermatology market's growth, driven by rising skin disorder prevalence, sustains demand for DERMATOP but faces headwinds from generics and innovative therapies.
• Patent expiries and competitive pressures necessitate formulation innovation and strategic repositioning to maintain market share.
• Regional dynamics, regulatory changes, and manufacturing stability critically influence DERMATOP's revenue trajectory.
• Long-term growth hinges on embracing formulation advancements, expanding indications, and penetrating emerging markets.
• Stakeholders should monitor epidemiological trends, regulatory policies, and competitive innovations continually to optimize financial outcomes.

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FAQs

1. What are the primary indications for DERMATOP?
DERMATOP is primarily used to treat inflammatory skin conditions such as psoriasis, eczema, dermatitis, and allergic reactions due to its corticosteroid potency.

2. How does patent expiration affect DERMATOP’s market?
Patent expirations typically lead to increased generic competition, resulting in lower prices and reduced profit margins, requiring brand differentiation strategies for continued market relevance.

3. Are there any safety concerns associated with DERMATOP?
Long-term or inappropriate use of potent corticosteroids like DERMATOP can cause skin atrophy, striae, and systemic effects. Regulatory agencies emphasize proper usage and monitoring.

4. Which regions are driving the demand for DERMATOP?
North America and Europe constitute mature markets, while Asia-Pacific and Latin America are significant growth regions due to increasing prevalence and expanding healthcare access.

5. What innovations could secure DERMATOP’s future market position?
Formulation improvements (e.g., non-steroidal alternatives, combination therapies), extended indications, and enhanced safety profiles are key to maintaining competitiveness.

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Sources

[1] Market Research Future. "Global Dermatology Therapeutics Market." 2022.
[2] World Health Organization. "Global Report on Psoriasis and Eczema." 2020.
[3] Company Financial Reports. "Dermatology Product Portfolio." 2022.
[4] IQVIA. "Global Pharmaceutical Market Insights." 2022.