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Last Updated: December 28, 2025

DERMACORT Drug Patent Profile


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

Dermacort is a drug marketed by Monarch Pharms and Solvay and is included in three NDAs.

The generic ingredient in DERMACORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dermacort

A generic version of DERMACORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for DERMACORT
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 8
DailyMed Link:DERMACORT at DailyMed
Drug patent expirations by year for DERMACORT
Recent Clinical Trials for DERMACORT

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
Children's Oncology GroupPhase 1
EsPhALL network I-BFM Study GroupPhase 3

See all DERMACORT clinical trials

US Patents and Regulatory Information for DERMACORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Monarch Pharms DERMACORT hydrocortisone CREAM;TOPICAL 083011-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Solvay DERMACORT hydrocortisone LOTION;TOPICAL 084573-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Solvay DERMACORT hydrocortisone LOTION;TOPICAL 086462-001 Approved Prior to Jan 1, 1982 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

EU/EMA Drug Approvals for DERMACORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185Treatment of adrenal insufficiency in adults. Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for DERMACORT

Last updated: July 28, 2025

Introduction

DERMACORT, a topical corticosteroid formulation primarily containing triamcinolone acetonide, has long been a cornerstone in dermatological treatments for inflammatory skin conditions. With its established efficacy and widespread clinical application, understanding its market dynamics and financial trajectory is critical for stakeholders spanning pharmaceutical companies, investors, healthcare providers, and regulatory agencies.

This report offers a comprehensive analysis of DERMACORT’s current market landscape, emerging trends, competitive positioning, regulatory environment, and forecasted revenue potential, aligning with business strategies in a rapidly evolving pharmaceutical sector.

Market Overview

Product Profile and Therapeutic Application

DERMACORT is predominantly prescribed for dermatitis, psoriasis, allergic reactions, and severe eczema. Its anti-inflammatory and immunosuppressive properties have sustained its utility in dermatology. As a topical corticosteroid, DERMACORT offers rapid symptom relief with a generally favorable safety profile when used appropriately.

Market Penetration and Global Reach

Initially launched in the late 20th century, DERMACORT established itself as a leading topical corticosteroid product. Its market penetration is highest in North America, Europe, and parts of Asia-Pacific, driven by favorable prescribing habits, high prevalence of dermatological conditions, and established healthcare infrastructure.

Recent years have seen incremental penetration in emerging markets, bolstered by increasing healthcare expenditure, rising awareness of skin diseases, and expanding distribution channels.

Market Dynamics

Drivers

  • Prevalence of Dermatological Conditions: The global incidence of skin disorders such as eczema and psoriasis continues to rise, fueled by environmental factors, lifestyle changes, and increased diagnosis rates [1].

  • Physician Preference for Topical Steroids: Favorable efficacy-to-safety profile, ease of application, and patient compliance reinforce early adoption by dermatologists.

  • Expanding Pediatric and Geriatric Use: Growing focus on pediatric skin care and age-related skin disease management expands application scope.

  • Innovation and Formulation Improvements: Development of combination formulations and reduced potency variants enhances safety, adherence, and therapeutic outcomes.

Challenges

  • Regulatory Scrutiny and Safety Concerns: Long-term use of corticosteroids can lead to adverse effects such as skin atrophy, hypothalamic-pituitary-adrenal (HPA) axis suppression, prompting regulatory authorities to impose restrictions and cautionary advisories.

  • Generic Competition: Market entry of generics and over-the-counter (OTC) options intensifies price competition, impacting profit margins.

  • Patient Compliance Issues: Concerns over potential side effects and proper application affect continued adherence and market sustainability.

Regulatory Environment

Key regulatory bodies including the FDA (U.S.), EMA (Europe), and PMDA (Japan) closely monitor corticosteroid safety profiles. Regulatory agencies emphasize restricted indications, dosage limits, and labeling updates to mitigate adverse effects. Patent exclusivity periods influence market exclusivity timelines, with many formulations approaching patent expiry, opening avenues for generics.

Financial Trajectory Analysis

Historical Revenue and Market Share

DERMACORT’s initial launch saw robust sales driven by its early-mover advantage and high demand. Over the last decade, revenues have plateaued in mature markets due to patent expiry and increased generic competition but remain resilient owing to brand loyalty and clinical efficacy.

Forecasted Revenue Trends

Projections anticipate moderate growth over the next five years, driven primarily by:

  • Emerging Market Expansion: Increased healthcare access and dermatology awareness support higher sales volumes.

  • New Indications: Off-label uses and adjunctive therapies expand potential markets.

  • Formulation Diversification: Introduction of novel, lower-potency, or combination products may command premium pricing.

According to industry analysts, the global topical corticosteroids market is expected to grow at a CAGR of approximately 4-5% through 2028 [2]. DERMACORT, as a key player in this segment, will likely follow this trajectory, with revenue stabilization in mature markets and growth in emerging regions.

Impact of Patent Expiry and Generic Competition

Patent expiries are pivotal in shaping DERMACORT’s financial outlook. Generics offer price reductions of up to 80%, reducing profit margins but expanding overall market volume. Strategic patent defense and formulation innovation remain essential to sustain profitability.

Manufacturing and Supply Chain Considerations

Manufacturers are investing in supply chain resilience to mitigate disruptions influenced by geopolitical tensions and global crises, which directly impact profitability and market availability.

Competitive Landscape

DERMACORT faces competition from other topical corticosteroids like hydrocortisone, betamethasone, and clobetasol, and from combination therapies incorporating antihistamines or calcineurin inhibitors. Its differentiation lies in potency, safety profile, and physician familiarity.

Major pharmaceutical firms investing in dermatology are deploying strategic alliances and marketing campaigns to retain market share while optimizing generic production.

Regulatory and Ethical Factors

Growing emphasis on medication safety mandates rigorous post-market surveillance of corticosteroids. Compliance with labeling, indication restrictions, and dosage guidelines are critical to market retention and avoiding penalties or bans.

Additionally, ethical marketing practices and patient education initiatives influence prescribing behaviors and overall demand.

Opportunities and Future Outlook

The future of DERMACORT hinges on:

  • Development of Enhanced Delivery Systems: Nanotechnology and bioavailability improvements could lead to more effective formulations with fewer side effects.

  • Digital and Teledermatology Integration: Remote diagnosis and prescription management expand reach into underserved regions.

  • Personalized Medicine Approaches: Biomarker-driven therapy optimization may facilitate tailored corticosteroid usage, improving safety and efficacy.

  • Regulatory Pathways for Biosimilars: Accelerated approval processes could introduce cost-effective biosimilars, intensifying competition but also opening new markets.

Key Takeaways

  • Steady Market Presence: DERMACORT maintains a significant role in dermatology, especially in mature markets where brand loyalty persists.

  • Growth in Emerging Markets: Regional expansion presents substantial growth opportunities, mitigated by regulatory and pricing pressures.

  • Patent and Competition Dynamics: Approaching patent expiry necessitates strategic innovation and portfolio diversification.

  • Safety and Regulatory Oversight: Balancing efficacy with safety concerns is crucial to sustain market access.

  • Innovation and Digital Health: Embracing technological advances can unlock new applications and improve patient outcomes, influencing long-term financial health.

Conclusion

DERMACORT’s market dynamics reflect a typical life cycle marked by initial rapid growth, followed by maturation, and eventual commoditization through generics. While regulatory scrutiny and competitive pressures challenge sustained profitability, strategic investments in formulation innovation, regional expansion, and digital health integration reveal opportunities for future growth.

Effective navigation of regulatory frameworks, coupled with a focus on safety, efficacy, and market adaptation, will be paramount. Stakeholders should monitor patent landscapes, emerging therapies, and technological trends to optimize their investment and market strategies concerning DERMACORT.


FAQs

1. What are the primary factors influencing DERMACORT's market growth?
The rise in skin disorder prevalence, physician preference for topical corticosteroids, expansion into emerging markets, and formulation innovations drive growth.

2. How does patent expiry impact DERMACORT’s revenue?
Patent expiration allows generic competition, significantly reducing prices and profit margins but potentially increasing sales volume in broader markets.

3. What safety concerns affect DERMACORT’s prescribing patterns?
Long-term corticosteroid use risks include skin atrophy, HPA axis suppression, and systemic effects, prompting cautious prescribing and regulatory restrictions.

4. What strategic considerations exist for prolonging DERMACORT’s market relevance?
Formulation improvements, entering new indications, geographic expansion, and digital health integration are key strategies.

5. Are biosimilars relevant in the corticosteroid market?
While biosimilars are more common in biologics, chemically synthesized corticosteroid equivalents could emerge, intensifying market competition.


References

  1. World Health Organization. Global prevalence estimates of dermatological conditions. WHO Report, 2022.
  2. MarketsandMarkets. Topical Corticosteroids Market by Type, Portability, and Region — Global Forecast to 2028. 2022.

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