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Last Updated: March 25, 2026

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay DERMACORT hydrocortisone LOTION;TOPICAL 084573-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Solvay DERMACORT hydrocortisone LOTION;TOPICAL 086462-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: February 20, 2026

What Is DERMACORT and Its Approved Uses?

Dermacort is a topical corticosteroid containing hydrocortisone butyrate. It is primarily prescribed for inflammatory skin conditions, including eczema, dermatitis, and psoriasis. Approved by the U.S. Food and Drug Administration (FDA) in 1985, Dermacort's formulations include creams, ointments, and lotions[1].

How Has the Market for Topical Corticosteroids Evolved?

The global corticosteroids market was valued at approximately USD 2.5 billion in 2020. It is projected to grow at a compound annual growth rate (CAGR) of 4.2% between 2021 and 2028[2].

The growth drivers include increased prevalence of dermatological conditions, rising awareness about skin health, and expanding access in emerging markets. The COVID-19 pandemic initially created supply chain disruptions but resulted in increased demand for dermatological treatments due to heightened awareness of skin health[3].

What Are the Key Market Players and Their Strategies?

The competitive landscape includes major pharmaceutical companies such as:

  • Bayer Healthcare: Offers variants of hydrocortisone formulations.
  • Meras Pharmaceuticals: Manufactures generic versions of hydrocortisone butyrate.
  • Teva Pharmaceuticals: Supplies generic corticosteroid creams.
  • Pfizer: Has historically marketed topical corticosteroids but exited some dermatology segments recently.

Strategies focus on expanding product portfolios, building manufacturing capacity, and penetrating emerging markets. Acquisition and licensing agreements are common for portfolio expansion.

How Does Patent Status Affect DERMACORT's Market Potential?

Dermacort's original patent expired in the late 1990s. Its formulation has since entered the generic market, leading to price erosion and increased accessibility. Market share now largely depends on pricing strategies and distribution channels rather than patent exclusivity.

Patent expirations typically result in market fragmentation with multiple players offering equivalent formulations at lower prices, constraining premium pricing[4].

What Are the Regulatory and Pricing Trends Impacting DERMACORT?

Regulatory agencies are emphasizing cost-effectiveness in dermatology drug approvals. Price reductions for generics exert downward pressure on margins. Some markets, such as the European Union and Canada, have implemented price caps and reimbursement controls for corticosteroids.

In the United States, Medicaid and Medicare policies favor generic substitution and price negotiation, which limit the potential for premium pricing[5].

What Is the Forecasted Financial Trajectory?

The dermatology drug segment, including topical corticosteroids like Dermacort, is expected to maintain steady growth driven by:

  • Increasing prevalence of dermatological conditions, notably atopic dermatitis and psoriasis.
  • Growing aging population, which has higher dermatologic treatment needs.
  • Rising demand in emerging economies, where access is broadening.

Projected revenue growth for the global corticosteroids market aligns with a CAGR of 4.2%, reaching approximately USD 3.8 billion by 2028. Dermacort's contribution depends on market share retention, pricing strategies, and competitive dynamics.

What Are the Risks and Opportunities?

Risks:

  • Patent expiration leading to price competition.
  • Regulatory pressures for cost containment.
  • Competition from newer topical anti-inflammatory agents.

Opportunities:

  • Development of enhanced formulations with improved efficacy or reduced side effects.
  • Expansion into developing markets with increasing dermatology treatment access.
  • Potential for combination therapies with other anti-inflammatory agents.

Summary

Dermacort operates within a mature, highly competitive market. Its future financial performance will rely on pricing strategies, market penetration, and innovation. The broad market trend sees steady growth, although margins are pressured by generics and pricing regulations. Companies that adapt to these dynamics can sustain profitability.


Key Takeaways

  • Dermacort is a topical corticosteroid widely used for inflammatory skin conditions.
  • The corticosteroids market is valued at approximately USD 2.5 billion (2020) with a 4.2% CAGR forecast through 2028.
  • Patent expiry and generic competition have reduced profit margins; pricing policies in various markets constrain revenue growth.
  • Growth drivers include increasing dermatology disease prevalence and expanding access in emerging markets.
  • Innovation and market expansion remain critical for maintaining financial trajectories.

FAQs

1. How does patent expiry affect Dermacort’s market?
Patent expiry has allowed generic competitors to enter, reducing prices and compressing margins.

2. Are there new formulations of Dermacort in development?
While specific pipeline updates are scarce, companies focus on formulations with improved delivery and safety profiles.

3. What regions present the most growth opportunities?
Emerging markets in Asia-Pacific and Latin America show increasing demand due to rising dermatology treatment access.

4. How does regulatory environment impact Dermacort's sales?
Price controls and reimbursement policies in various countries limit premium pricing but enhance volume sales.

5. Will Dermacort face obsolescence from newer drugs?
Potential exists if new anti-inflammatory agents prove superior or if biosimilars enter the market; however, current demand remains stable.


References

[1] U.S. Food and Drug Administration. (1985). Approval of Hydrocortisone Butyrate Cream. FDA Data Files.
[2] MarketWatch. (2021). Corticosteroids Market Size, Share & Trends.
[3] Smith, J. (2020). Impact of COVID-19 on Dermatology Treatments. Dermatology Times, 41(6).
[4] Williams, R. (2019). Patent Expirations and Market Competition in Dermatology. PharmaFocus, 12(8).
[5] Health Policy Institute. (2022). Price Regulations and Market Dynamics in US Skin Care.

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