Last Updated: May 3, 2026

METICORTELONE Drug Patent Profile


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

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

The generic ingredient in METICORTELONE is prednisolone acetate. There are eighty-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Meticortelone

A generic version of METICORTELONE was approved as prednisolone acetate by LUPIN LTD on August 2nd, 2024.

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Summary for METICORTELONE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 94
Clinical Trials: 10
DailyMed Link:METICORTELONE at DailyMed
Recent Clinical Trials for METICORTELONE

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

SponsorPhase
Children's Oncology GroupPhase 2
Children's Oncology GroupPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2

See all METICORTELONE clinical trials

US Patents and Regulatory Information for METICORTELONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering METICORTELONE prednisolone acetate INJECTABLE;INJECTION 010255-002 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

Market Dynamics and Financial Trajectory for Meticortelone

Last updated: March 2, 2026

What is Meticortelone?

Meticortelone is a synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties. It is primarily used in the treatment of inflammatory and autoimmune conditions. The drug is marketed under various brand names and exists in multiple formulations, primarily for topical and systemic administration.

Market Overview

Current Indications

  • Autoimmune disorders
  • Allergic conditions
  • Dermatological diseases
  • Endocrine disorders involving adrenal insufficiency

Existing Competitors

  • Prednisone
  • Dexamethasone
  • Hydrocortisone
  • Fludrocortisone

Regulatory Status

  • Approved in major markets including the US, EU, and Japan
  • Market exclusivity varies by region, with some formulations facing patent expirations in the next 1-3 years

Patent Landscape

  • Patents covering specific formulations and delivery methods face expiration timelines from 2024 to 2027
  • Patent challenges and generic entry are anticipated post-expiration

Market Dynamics

Key Drivers

  • Growing prevalence of autoimmune diseases and inflammatory disorders
  • Rising aging population leading to increased corticosteroid use
  • Expansion into emerging markets with improved healthcare infrastructure

Key Challenges

  • Patent expirations leading to generic competition
  • Safety concerns over long-term corticosteroid use
  • Regulatory hurdles for new formulations

Regional Markets

  • North America holds approximately 40% of the corticosteroid market share
  • Europe accounts for 25%, with growth driven by aging populations
  • Asia-Pacific shown to be the fastest-growing region, with a CAGR near 8% (2022–2027)

Market Trends

  • Shift toward new delivery systems, such as long-acting injectables
  • Increased use of combination therapies to mitigate side effects
  • Adoption of biosimilar and generic corticosteroids post-patent expiration

Financial Trajectory

Revenue Projections

Year Global Market Size (USD billions) Projected Growth Rate Key Assumptions
2023 5.2 4.5% Steady demand, moderate impact of generics
2024 5.4 4.2% Patent expiries reduce branded sales
2025 5.6 4.0% Increased generic competition
2026 5.8 3.8% Market consolidation, new formulations
2027 6.0 3.5% Biosimilar adoption stabilizes revenues

Financial Impact of Patent Expirations

  • Patent cliff expected in 2024-2025 may lead to a revenue decline of 15-20% in branded formulations
  • Generic corticosteroids have pricing advantages of 25-35% over branded options
  • Industry analysts forecast that me too products could capture up to 60% of the market share post-patent expiry

Investment Opportunities

  • Development of targeted, long-acting corticosteroid formulations
  • Entry into biosimilar markets
  • Expansion into emerging regions with unmet needs

Risks to Financial Trajectory

  • Potential accelerated generic invasion
  • Regulatory delays for new product launches
  • Market saturation in mature regions

Strategic Considerations

R&D Focus

  • Innovate with formulations that reduce systemic exposure
  • Explore combination therapies reducing side effects

Market Entry Strategies

  • Partner with local manufacturers for emerging markets
  • Secure data exclusivity through orphan drug designations in select indications

Regulatory Pathways

  • Expedite approval via accelerated pathways for new formulations
  • Engage early with regulatory agencies for safety profile updates and post-marketing surveillance

Key Takeaways

  • The global corticosteroid market, including Meticortelone, faces revenue pressures from patent expiries and generic competition
  • Growth is driven by increasing disease prevalence and demographic shifts, particularly in Asia-Pacific
  • Innovations in delivery systems and biosimilars represent critical growth avenues
  • Financial outlook indicates moderate, steady growth with notable declines post-2024 patent cliff
  • Strategic R&D and geographic expansion are key to maintaining market relevance

FAQs

1. When do the patents for Meticortelone typically expire?
Patents vary by formulation but generally expire between 2024 and 2027, opening opportunities for generics.

2. What are the main competing drugs against Meticortelone?
Prednisone, dexamethasone, hydrocortisone, and fludrocortisone.

3. How is the Asian market influencing overall sales?
Asia-Pacific exhibits a compound annual growth rate of about 8%, driven by rising healthcare access and demographic trends.

4. What innovations are most promising for future growth?
Long-acting injectable formulations, combination therapies reducing side effects, and biosimilars.

5. What regulatory challenges could impact Meticortelone's market?
Delays in approval for new formulations, safety concerns over corticosteroids, and changes in reimbursement policies.


References

[1] MarketsandMarkets. (2022). Corticosteroids Market by Product Type, Application, and Region – Global Forecast to 2027.

[2] U.S. Food and Drug Administration. (2023). Approved Drugs Database.

[3] European Medicines Agency. (2023). Market authorization data for corticosteroids.

[4] IQVIA. (2022). Global Trends in Corticosteroid Use.

[5] Statista. (2023). Aging Population and Disease Prevalence Data in Asia-Pacific.

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