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Last Updated: March 19, 2026

DEPO-MEDROL Drug Patent Profile


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When do Depo-medrol patents expire, and when can generic versions of Depo-medrol launch?

Depo-medrol is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DEPO-MEDROL 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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Summary for DEPO-MEDROL
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DEPO-MEDROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer DEPO-MEDROL methylprednisolone acetate INJECTABLE;INJECTION 011757-002 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer DEPO-MEDROL methylprednisolone acetate INJECTABLE;INJECTION 011757-001 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer DEPO-MEDROL methylprednisolone acetate INJECTABLE;INJECTION 011757-004 Approved Prior to Jan 1, 1982 AB RX 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

Investment Scenario and Fundamentals Analysis for DEPO-MEDROL

Last updated: February 20, 2026

What is DEPO-MEDROL?

DEPO-MEDROL is a corticosteroid medication containing methylprednisolone acetate. It is used for managing inflammation, allergic reactions, and immune-related conditions. Approved by the FDA in 1957, it is marketed primarily for intramuscular, intra-articular, and epidural injection. Its patent protection expired decades ago, leading to widespread generic manufacturing.

Market Overview

The global corticosteroid injection market was valued at approximately USD 2.8 billion in 2022. It exhibits a compound annual growth rate (CAGR) of about 5% over the next five years. Key growth drivers include increasing prevalence of inflammatory and autoimmune diseases, rising adoption in pain management, and expanding use in post-operative treatments.

Key Market Segments

Segment Contribution to Market (2022) Growth Drivers
Pain Management 35% Rising osteoarthritis, spinal conditions
Autoimmune Disorders 25% Growing autoimmune disease incidence
Allergic & Respiratory Conditions 15% Increasing asthma and allergic responses
Other (e.g., dermatology) 25% Chronic dermatological conditions

Market Dynamics

  • Generic Competition: Multiple manufacturers produce methylprednisolone acetate, reducing pricing power for branded products.
  • Regulatory Environment: Tightening regulations on injection practices and manufacturing standards influence market entry.
  • Pricing Trends: US pricing for DEPO-MEDROL averages USD 20–30 per single injection, with variations depending on setting and supplier.

Competitive Landscape

The market for corticosteroid injections comprises several global players such as Pfizer, Teva, Mylan, and Sandoz, producing methylprednisolone acetate generics. Branded versions have limited presence, largely replaced by generics.

Market Share Insights

Manufacturer Estimated Market Share Notable Offerings
Pfizer (Depo-Medrol) 60% DEPO-MEDROL branded drug
Teva 20% Generic methylprednisolone
Mylan 10% Generic methylprednisolone
Others 10% Various regional players

Investment Fundamentals

Revenue Potential

  • The global methylprednisolone acetate market is expected to reach USD 3.6 billion by 2028.
  • DEPO-MEDROL's sales depend heavily on hospital and clinic utilization, reimbursement policies, and regional demand.

Patents and Regulatory Status

  • No active patents restrict DEPO-MEDROL since patent expiration occurred in the 1980s.
  • Regulatory hurdles are minimal but involve compliance with manufacturing standards (FDA, EMA).

Manufacturing and Supply Chain

  • Large-scale manufacturing presence ensures consistent supply.
  • Sourcing raw materials is stable; corticosteroids are derived from chemical synthesis.

Pricing and Reimbursement

  • Reimbursement varies by region; Medicare and private insurers typically reimburse USD 20–40 per injection.
  • Price erosion due to generics pressures impacts profit margins.

Risks and Challenges

  • Decline in prescriptions due to newer therapies and biologics.
  • Potential for Shrinking margins driven by pricing pressure and government policies.
  • Competition from alternative delivery methods (oral, topical) influences demand.

Investment Outlook

  • Market growth driven by expanding indications, especially in pain management and autoimmunity.
  • High generic competition limits profit margins for branded versions.
  • Entry into emerging markets offers growth opportunities but requires regulatory approval.

Key Investment Considerations

  • Market Penetration: Existing dominance by Pfizer's DEPO-MEDROL limits growth; investors should watch for potential new formulations or indications.
  • Patent Expiry Impact: No patent protection currently; focus on manufacturing efficiencies and brand loyalty.
  • Alternative Therapies: Biologics and newer injection drugs might reduce demand for traditional corticosteroids.
  • Regulatory Risks: Changes impacting injections, safety standards, or reimbursement policies could affect revenues.

Summary Table of Investment Dynamics

Aspect Status Implication
Patent Status Expired Minimal legal barriers to generics
Market Growth 5% CAGR projected Opportunities in expanding markets
Competitive Intensity High due to generics Margin pressures
Regulatory Environment Stable but evolving Compliance costs
Reimbursement Policies Variable, region-dependent Revenue depends on reimbursement rates

Key Takeaways

  • DEPO-MEDROL faces limited growth prospects due to high generic competition.
  • Market expansion hinges on emerging markets and new indications.
  • Revenue stability depends on healthcare policies, reimbursement rates, and physician prescribing habits.
  • Investment should consider the decline in branded drug margins and the evolving landscape of pain and autoimmune treatments.

FAQs

Q1: Is there still significant demand for DEPO-MEDROL?
A1: Demand persists in specific therapeutic areas, primarily pain management and autoimmune conditions, but overall market share is declining due to generics.

Q2: How does patent expiry affect DEPO-MEDROL profitability?
A2: Patent expiration has allowed generic producers to enter, reducing prices and profit margins for the branded product.

Q3: What are growth opportunities for DEPO-MEDROL?
A3: Opportunities exist in emerging markets and newly approved indications, though competition from newer therapies remains a challenge.

Q4: How do regulatory changes impact the market?
A4: Stricter quality standards or injection safety regulations could increase manufacturing costs and influence supply dynamics.

Q5: What role do reimbursement policies play?
A5: Reimbursement levels influence the affordability and prescribing patterns for DEPO-MEDROL, affecting overall revenues.


References:

[1] Transparency Market Research. (2023). Corticosteroid Market Analysis.
[2] IQVIA. (2022). Global Injection Market Report.
[3] FDA. (2021). Summary of Medical Device and Drug Regulations.
[4] Statista. (2022). Global Market for Corticosteroids.
[5] IMS Health. (2022). Prescription Trends and Market Share Data.

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