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Last Updated: December 29, 2025

METICORTEN Drug Patent Profile


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

Meticorten is a drug marketed by Schering and is included in one NDA.

The generic ingredient in METICORTEN is prednisone. There are sixteen drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the prednisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Meticorten

A generic version of METICORTEN was approved as prednisone by WATSON LABS on December 31st, 1969.

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Summary for METICORTEN
Drug patent expirations by year for METICORTEN
Recent Clinical Trials for METICORTEN

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

SponsorPhase
Mayo ClinicPhase 2
ADC TherapeuticsPhase 2
Joseph TuscanoPhase 2

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US Patents and Regulatory Information for METICORTEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering METICORTEN prednisone TABLET;ORAL 009766-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Schering METICORTEN prednisone TABLET;ORAL 009766-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

Market Dynamics and Financial Trajectory for Meticorten

Last updated: July 27, 2025

Introduction

Meticorten, a trade name for the corticosteroid drug Prednisone, is integral to the treatment of inflammatory and autoimmune conditions. Its effectiveness in managing conditions such as arthritis, asthma, and blood disorders has sustained demand over decades. Understanding the market dynamics and financial trajectory of Meticorten provides insights into its current value proposition and future growth potential amid evolving pharmaceutical landscapes.


Market Overview

Prednisone’s widespread application classifies Meticorten within a lucrative segment of corticosteroids—critical in managing both acute and chronic inflammatory states. With an aging global population and rising incidences of autoimmune diseases, corticosteroid demand remains resilient. The drug's affordability, combined with extensive clinical acceptance, sustains its status as a core therapeutic agent.

In 2019, the global corticosteroid market was valued at approximately $4.89 billion and is projected to grow at a compound annual growth rate (CAGR) of roughly 4% through 2027 [1]. Prednisone accounts for a significant share within this market due to its efficacy and cost-effectiveness, making it a first-line therapy in many settings.


Regulatory and Patent Landscape

While the original patents for Prednisone have long expired, resulting in widespread generic manufacturing, this has led to significant price compression. However, certain formulations and delivery mechanisms—such as delayed-release or injectable forms—may still be patent-protected or under proprietary licensing, offering premium pricing opportunities.

Regulatory agencies like the FDA and EMA maintain rigorous standards, but the generic nature of Prednisone limits exclusivity durations. As a result, pharmaceutical companies focus on geographical expansion, formulation innovations, and combination therapies to sustain revenue streams.


Market Drivers

  • Rising Prevalence of Autoimmune Disorders: Conditions such as rheumatoid arthritis, lupus, and inflammatory bowel disease are increasing globally, especially in emerging markets, fueling demand for corticosteroids like Meticorten.
  • Elderly Population: Age-related autoimmune and inflammatory conditions contribute to sustained corticosteroid use.
  • Healthcare Access Expansion: Improved healthcare infrastructure in emerging economies enables broader prescription of affordable corticosteroids.
  • Cost-Effective Therapeutic Option: As a generic, Prednisone under the Meticorten brand offers an economical treatment choice, especially in resource-constrained healthcare systems.

Market Restraints

  • Side Effect Profile: Long-term corticosteroid therapy is associated with notable adverse effects—osteoporosis, hyperglycemia, immunosuppression—that restrict prolonged use.
  • Emerging Alternatives: Biologics and targeted immunotherapies increasingly replace steroids for certain autoimmune conditions, potentially constricting market growth.
  • Patent Challenges and Generics: Widespread generic availability compresses margins and limits profitability for branded versions.

Competitive Landscape

The corticosteroid market is highly commoditized, with key players including Pfizer, Mylan (now part of Viatris), and Teva Pharmaceuticals. These companies produce Prednisone under various brand names, including Meticorten, often competing chiefly on price and formulations.

Emerging players focus on niche formulations or combination therapies, attempting to differentiate amidst generic drug competition. Meanwhile, pharmaceutical firms continue R&D to develop novel corticosteroid derivatives or delivery methods aimed at minimizing side effects.


Financial Trajectory and Revenue Outlook

The financial prospects for Meticorten hinge upon multiple factors:

  • Market Penetration in Emerging Markets: Markets such as India, China, and Brazil exhibit growing corticosteroid consumption driven by expanding healthcare access.
  • Formulation Innovations: Premium formulations, including controlled-release or injectable variants, can command higher prices and extend lifecycle opportunities.
  • Pricing Strategies: Cost-sensitive markets favor generic versions, pressuring profit margins but volumes compensate.
  • Regulatory Approvals: New indications or formulations gaining regulatory approval can unlock additional revenue streams.

Given these parameters, the global Prednisone market, with Meticorten as a significant player, is expected to demonstrate steady growth over the next 5-7 years. Revenues are projected to sustain a CAGR of approximately 4%, driven primarily by volume expansion rather than price hikes, which are constrained by high generic competition.


Market Challenges and Opportunities

Challenges:

  • Limited patent protection restricts exclusive rights, intensifying generic competition.
  • Growing awareness of corticosteroid side effects prompts cautious prescribing practices.
  • The rise of targeted biologics may marginalize corticosteroids in specific conditions.

Opportunities:

  • Formulation Advancements: Developing formulations that reduce adverse effects could improve long-term adherence.
  • Combination Therapies: Integrating Prednisone with other agents to enhance efficacy and therapeutic index.
  • Expanding Indications: Exploring new therapeutic areas such as dermatology or COVID-19 related inflammatory responses.

Impact of Healthcare Trends

The ongoing shift towards personalized medicine and biologics influences corticosteroid markets. However, their role remains essential, particularly as cost-effective, fast-acting agents. The COVID-19 pandemic has underscored corticosteroids' importance; dexamethasone, a closely related corticosteroid, gained emergency approval for severe COVID-19, indirectly highlighting the enduring relevance of corticosteroids like Prednisone (Meticorten).


Strategic Outlook

Pharmaceutical companies operating in this space should prioritize:

  • Geographical Expansion: Tapping into emerging markets with rising disposable incomes and increasing disease burden.
  • Product Diversification: Innovating formulations and delivery methods to differentiate from generic competitors.
  • Regulatory Engagement: Navigating evolving approval pathways for new indications and formulations.
  • Pricing Strategies: Balancing affordability with profitability, leveraging local healthcare policy trends.

Key Takeaways

  • Steady Demand Sustained by Global Disease Burden: Rising autoimmune and inflammatory diseases, especially in aging populations and developing economies, underpin consistent corticosteroid demand.
  • Intense Competitive Landscape: Widespread generic manufacturing compresses margins; differentiation centers on formulations and regional market penetration.
  • Revenue Growth Driven by Volume, Not Price: Market growth entails volume expansion bolstered by emerging market penetration, rather than significant price increases.
  • Innovative Formulations and New Indications Offer Growth Opportunities: R&D efforts focusing on improved delivery systems and expanding therapeutic uses can extend Meticorten’s lifecycle.
  • Regulatory and Market Challenges Require Strategic Navigation: Companies must adapt to patent expiry effects, side effect profiles, and evolving treatment paradigms involving biologic agents.

Conclusion

Meticorten, as a leading Prednisone formulation, occupies a stable yet highly competitive segment within the corticosteroid market. Its financial trajectory reflects broader market trends—predictable growth driven by demographic changes and healthcare access expansion, offset by patent expiries and evolving treatment standards. Success hinges on innovation, regional expansion, and strategic positioning within the shifting landscape of autoimmune and inflammatory disease management.


FAQs

1. How does the patent landscape impact Meticorten’s market potential?
Since the original Prednisone patents expired decades ago, the market is dominated by generics. This results in price pressures and limited exclusivity, emphasizing the importance of formulations and regional branding for continued profitability.

2. What are the main competitors to Meticorten in the corticosteroid segment?
Generic manufacturers like Mylan (Viatris), Teva, and local Asian producers are primary competitors, offering similar Prednisone formulations at lower prices. Brand name competitors, if any, generally have minimal differentiation.

3. How is the rise of biologics affecting corticosteroid demand?
Biologics offer targeted therapy with fewer systemic side effects for certain autoimmune diseases, which may reduce corticosteroid prescriptions in some indications. However, corticosteroids remain essential, especially for acute management and in resource-limited settings.

4. What opportunities exist for extending Meticorten’s market life?
Formulation innovations (e.g., controlled-release), exploring new indications, and regional expansion into emerging markets provide avenues for growth despite patent expirations.

5. What role does healthcare policy play in shaping the future of Meticorten?
Policies promoting affordable healthcare and expanding access in developing countries facilitate corticosteroid use. Conversely, regulations favoring newer, targeted therapies could challenge corticosteroid market shares.


References

[1] Markets and Markets. "Corticosteroids Market by Type, Route of Administration, Application, End User - Global Forecast to 2027." 2020.

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