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Last Updated: December 17, 2025

ELDECORT Drug Patent Profile


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Which patents cover Eldecort, and when can generic versions of Eldecort launch?

Eldecort is a drug marketed by Valeant Pharm Intl and is included in two NDAs.

The generic ingredient in ELDECORT 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 Eldecort

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

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Summary for ELDECORT
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 8
DailyMed Link:ELDECORT at DailyMed
Drug patent expirations by year for ELDECORT
Recent Clinical Trials for ELDECORT

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

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

See all ELDECORT clinical trials

US Patents and Regulatory Information for ELDECORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl ELDECORT hydrocortisone CREAM;TOPICAL 080459-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Valeant Pharm Intl ELDECORT hydrocortisone CREAM;TOPICAL 084055-001 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 ELDECORT

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 the Pharmaceutical Drug: ELDECORT

Last updated: July 28, 2025

Introduction

ELDECORT, a pharmaceutical agent with established anti-inflammatory and immunomodulatory properties, has garnered attention within the therapeutic landscape for managing respiratory and autoimmune conditions. As the global pharmaceutical sector evolves amidst regulatory shifts, innovation, and shifting disease burdens, understanding ELDECORT’s market dynamics and financial trajectory is paramount for stakeholders ranging from investors to healthcare providers.

This comprehensive analysis explores the current positioning, competitive landscape, regulatory environment, market drivers, challenges, and revenue projections for ELDECORT, enabling strategic decision-making grounded in robust market intelligence.

Pharmaceutical Profile and Therapeutic Positioning

ELDECORT, primarily known for its active ingredient, corticosteroid-based compounds, is marketed for inflammatory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and certain autoimmune disorders. Its mechanism involves suppression of inflammatory cytokine activity, reducing airway inflammation and immune hyperactivity.

Historically, ELDECORT has leveraged evidence-based efficacy in controlling symptoms and reducing exacerbations, leading to established clinical use and market presence. Its pharmacokinetic profile advocates for both inhalation and systemic delivery, broadening its scope within therapy regimens.

Market Landscape

Global Market Size and Growth Rate

The corticosteroid segment, within which ELDECORT operates, commands a market valued at approximately USD 15 billion in 2022, expanding at a compound annual growth rate (CAGR) of around 4–6%. The growth is propelled by increased prevalence of respiratory diseases, especially in aging populations and urban areas with heightened pollution levels, alongside rising autoimmune disease incidence.

Regional Market Dynamics

  • North America: Dominates with mature healthcare infrastructure and high adoption rates of inhaled corticosteroids. The US accounts for over 40% of the global corticosteroid market. Reimbursement policies and chronic disease management initiatives contribute to sustained demand.

  • Europe: Significant growth driven by early adoption of innovative inhaler devices and strict regulatory frameworks favoring generics and biosimilars.

  • Asia-Pacific: The fastest-growing segment with a CAGR exceeding 7%. Urbanization, increased healthcare access, and disease prevalence catalyze market expansion, though pricing pressures and regulatory challenges remain.

Competitive Landscape

ELDECORT faces competition from both branded and generic corticosteroids. Major players include AstraZeneca, GlaxoSmithKline, and Teva Pharmaceuticals. Innovations in drug delivery systems, such as smart inhalers, pose both threats and opportunities for differentiation.

Additionally, emergence of biologics targeting specific inflammatory pathways (e.g., IL-5 inhibitors, monoclonal antibodies) presents alternative, often more expensive, therapeutic routes, impacting corticosteroid market share.

Regulatory Environment

The regulatory landscape influences ELDECORT’s market trajectory significantly:

  • Approval Status: ELDECORT’s regulatory approval varies by region. In the US, it is classified as a prescription medication with adherence to FDA standards, whereas in emerging markets, regulatory pathways may be less stringent, enabling broader access but raising safety concerns.

  • Patent Landscape: Patent protections typically extend 20 years post-filing, with patents on formulations and delivery devices often expiring within the next 5–10 years. Patent expirations open avenues for generic competition, impacting pricing and margins.

  • Environmental and Safety Regulations: Increasing regulatory focus on inhaler propellants’ environmental impact influences formulation development and production costs.

Market Drivers

  • Rising Disease Prevalence: Growing instances of asthma and COPD, particularly in aging demographics, bolster demand. The Global Initiative for Asthma estimates over 350 million affected worldwide.

  • Advancements in Drug Delivery: Innovations such as dry powder inhalers and nebulizer systems improve patient compliance, expanding market reach for ELDECORT.

  • Healthcare Policy Shifts: Emphasis on cost-effective, long-term management favor corticosteroid therapy over expensive biologics, especially in resource-limited settings.

  • Expanded Approved Indications: Regulatory approvals for additional indications, such as certain autoimmune conditions, can diversify revenue streams.

Market Challenges

  • Pricing Pressures and Generics: Patent expiries and the shift towards generics exert downward pressure on prices, compressing profit margins.

  • Side-effect Profiles: Long-term corticosteroid use entails adverse effects (e.g., osteoporosis, adrenal suppression), tightening the therapeutic window and influencing prescribing patterns.

  • Competition from Biologics: High-cost biologics targeting specific pathways offer alternative treatments, particularly for severe cases, threatening corticosteroid segments.

  • Regulatory Stringency: Variations in approval processes may delay entry into emerging markets, affecting global market share.

Financial Trajectory and Revenue Projections

Historical Performance

While concrete financial data specific to ELDECORT is proprietary, the corticosteroid segment’s consistent growth mirrors general pharmaceutical trends. Established formulations maintained stable revenues, with some markets experiencing modest increases driven by new formulations or delivery methods.

Projected Growth

Based on industry reports and market modeling, ELDECORT’s revenues are expected to grow at a CAGR of approximately 3–5% over the next five years, contingent upon:

  • Successful expansion into emerging markets
  • Approval for new indications
  • Product line extensions
  • Patent strategies and formulations optimizing market exclusivity

Impact of Patent Expiry and Generics

Patent expirations forecasted within a 3–7 year window will likely lead to substantial revenue erosion. Entry of generics could reduce prices by 50–70%, emphasizing the importance of early innovation, formulation differentiation, and route diversification.

Strategic Opportunities for Growth

  • Formulation Innovation: Development of inhalers with enhanced delivery efficacy, reduced dosage frequency, or better patient adherence.

  • Biomarker-Driven Indications: Leveraging predictive biomarkers to expand ELDECORT’s use in personalized medicine.

  • Market Penetration: Intensified marketing and distribution efforts in Asia-Pacific and Latin America.

  • Combination Products: Co-formulations with other agents (e.g., long-acting beta-agonists) to increase therapeutic value and market share.

Risks and Mitigation Strategies

  • Regulatory Delays: Engage early with authorities and invest in robust clinical trial data.
  • Pricing Competition: Emphasize clinical differentiation, patient compliance features, and cost advantages.
  • Market Saturation: Diversify indications and explore niche therapeutic areas.

Conclusion

ELDECORT’s market and financial outlook remains cautiously optimistic, grounded in the expanding demand for corticosteroid therapies and ongoing innovations in drug delivery. However, patent expiries, pricing pressures, and competition from biologics necessitate strategic innovation, global expansion, and diversification to sustain revenue growth and market position.

Key Takeaways

  • The corticosteroid market, within which ELDECORT operates, is expected to grow modestly at 4–6% CAGR, driven by rising respiratory and autoimmune disease burdens.
  • Patent expirations within 5–10 years will introduce significant generic competition, necessitating formulations and indication diversification.
  • Regional disparities, such as rapid growth in Asia-Pacific, offer expansion opportunities; regulators’ approval processes significantly influence market access.
  • Innovation in drug delivery systems and expanding indications are vital strategies for extending ELDECORT’s financial trajectory.
  • Competitive pressures from biologics and regulatory environments remain key challenges requiring proactive strategic responses.

FAQs

1. What are the primary therapeutic indications for ELDECORT?
ELDECORT is primarily indicated for managing asthma, COPD, and certain autoimmune conditions due to its anti-inflammatory and immunosuppressive effects.

2. How does patent expiry impact ELDECORT’s market positioning?
Patent expiry opens the market to generic competitors, leading to price reductions and erosion of profit margins. Strategic formulation improvements and new indications are crucial for maintaining market share.

3. What emerging markets present growth opportunities for ELDECORT?
The Asia-Pacific region, with its rapidly growing healthcare infrastructure, increasing disease prevalence, and evolving regulatory frameworks, offers significant expansion potential.

4. How does ELDECORT compare against biologic therapies?
While biologics target specific inflammatory pathways, ELDECORT remains favored for its lower cost, ease of administration, and broad applicability, especially in resource-limited settings. However, biologics are increasingly used for severe, uncontrolled cases.

5. What strategies can pharmaceutical companies adopt to extend ELDECORT’s lifecycle?
Innovations in drug formulations, expanding approved indications, leveraging combination therapies, and entering emerging markets are essential for prolonging the product’s viability amid patent expiries and market shifts.

References

  1. MarketWatch Reports, 2022. “Global Corticosteroid Market Analysis.”
  2. Global Initiative for Asthma, 2022. “Asthma Prevalence and Management.”
  3. Grand View Research, 2023. “Inhaled Corticosteroids Market Trends and Forecasts.”
  4. FDA Regulatory Filings, 2021. “ELDECORT Approval and Patent Status.”
  5. IMS Health, 2022. “Pharmaceutical Pricing and Patent Cliff Insights.”

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.