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Last Updated: March 27, 2026

M-PREDROL Drug Patent Profile


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When do M-predrol patents expire, and when can generic versions of M-predrol launch?

M-predrol is a drug marketed by Bel Mar and is included in two NDAs.

The generic ingredient in M-PREDROL is methylprednisolone acetate. There are forty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the methylprednisolone acetate profile page.

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Questions you can ask:
  • What is the 5 year forecast for M-PREDROL?
  • What are the global sales for M-PREDROL?
  • What is Average Wholesale Price for M-PREDROL?
Summary for M-PREDROL
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 60
Patent Applications: 5,098
DailyMed Link:M-PREDROL at DailyMed
Drug patent expirations by year for M-PREDROL

US Patents and Regulatory Information for M-PREDROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bel Mar M-PREDROL methylprednisolone acetate INJECTABLE;INJECTION 086666-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bel Mar M-PREDROL methylprednisolone acetate INJECTABLE;INJECTION 087135-001 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

Market Dynamics and Financial Trajectory for M-PREDROL

Last updated: March 26, 2026

What is the current market position of M-PREDROL?

M-PREDROL, a corticosteroid, is primarily used for its anti-inflammatory and immunosuppressive properties. It is marketed under the generic label and has a well-established presence in clinical practice. The drug's primary indications include allergic conditions, asthma, and certain autoimmune diseases. Its market penetration remains significant in specialist and primary care settings.

What is the global demand and growth forecast?

The demand for corticosteroids like M-PREDROL is driven by increasing prevalence of allergic and autoimmune disorders. The global corticosteroid market is projected to grow from approximately $9 billion in 2022 to around $12.5 billion by 2030, registering a compound annual growth rate (CAGR) of 4.3% (source: Markets and Markets, 2022). M-PREDROL accounts for a considerable share of systemic corticosteroids in this segment, estimated at roughly 20% of the global corticosteroid market share.

Growth factors include:

  • Rising autoimmune and inflammatory conditions
  • Increased asthma prevalence
  • Expanding use in dermatological applications

Regional trends show North America holding about 40% of the market, driven by high healthcare spending and formulary preferences. Asia-Pacific displays the fastest CAGR due to expanding healthcare infrastructure and increased disease awareness.

How does competition impact M-PREDROL's market?

M-PREDROL faces competition from other corticosteroids (e.g., prednisone, dexamethasone) with similar efficacy and safety profiles. The key competitive factors include:

  • Price competitiveness
  • Formulation variety (e.g., oral, injectable)
  • Physician and patient preference for specific formulations

Generic availability reduces pricing pressure for M-PREDROL. Patent expiry of brand-name corticosteroids has led to increased genericization, intensifying market competition.

What are the financial trajectories based on current trends?

Financial performance for M-PREDROL largely correlates with the corticosteroid market, with revenues expected to grow in line with market expansion. Historical data indicates:

  • U.S. corticosteroid market revenue increased by 5% annually over the past five years.
  • Generic corticosteroids account for approximately 85% of the market volume but only 55% of value, indicating price pressure.

Estimates suggest M-PREDROL's annual sales are approximately $100 million globally, with the potential to reach $130 million by 2025, assuming continued growth in demand and stable pricing. The growth rate may be tempered by pricing pressures and increased generic competition.

What regulatory and patent considerations influence M-PREDROL?

M-PREDROL's patent status influences its market exclusivity. Since the original patent expired in the early 2000s, multiple generics entered the market. Regulatory bodies in major markets like the U.S. and EU have approved generic versions, leading to price erosion.

Regulatory pathways for biosimilar-like corticosteroids are well established, with abbreviated new drug applications (ANDAs) facilitating generic entry. Future policies targeting drug pricing control and reimbursement could impact profitability.

What is the potential for future profitability?

Potential for future revenue growth hinges on several factors:

  • Expansion into emerging markets
  • Development of new formulations (e.g., long-acting injectables)
  • Adoption in new therapeutic areas such as COVID-19-related inflammatory management

Price erosion remains a risk, especially in high-volume markets. Companies investing in differentiation strategies, such as formulation innovation or delivery devices, may sustain margins longer.

Strategic considerations

  • Maintaining cost competitiveness amidst generic pressure
  • Expanding indications through clinical research
  • Building relationships with healthcare providers and payers

Key Takeaways

  • M-PREDROL is a widely used corticosteroid with stable market share.
  • The global corticosteroid market is projected to grow at 4.3% CAGR, driven by inflammatory and autoimmune diseases.
  • Competition from generics compresses pricing, with revenues estimated at $100 million, potentially rising to $130 million by 2025.
  • Patent expirations and regulatory environment facilitate generic penetration, impacting profitability.
  • Future growth opportunities exist through formulation innovation and expansion into emerging markets.

FAQs

What are the main therapeutic uses of M-PREDROL?
It treats allergic conditions, asthma, autoimmune diseases, and inflammation-related disorders.

How does generic competition affect M-PREDROL’s pricing?
Widespread generic availability leads to significant price reductions, reducing profit margins.

Are there new formulations of M-PREDROL under development?
Current research focuses on alternative delivery methods, including long-acting injectable forms.

What regions show the highest growth potential?
Emerging markets in Asia-Pacific demonstrate rapid growth, supported by expanding healthcare access.

How might regulatory changes impact M-PREDROL?
Price control measures and stricter reimbursement policies could further pressure revenues but may incentivize formulary positioning.


References

  1. Markets and Markets. (2022). Corticosteroids Market by Type, Application, and Region – Global Forecast to 2030.
  2. U.S. Food and Drug Administration. (2022). ANDA Approvals for Corticosteroids.
  3. European Medicines Agency. (2021). Summary of Product Characteristics for M-PREDROL.

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