Last updated: February 20, 2026
What is the drug associated with NDC 00113-0141?
NDC 00113-0141 corresponds to Methylprednisolone Acetate Injectable Suspension, 40 mg/mL. It is a corticosteroid used for the treatment of inflammation and allergic reactions, primarily in acute settings.
What is the current market landscape?
Market size and growth
- The global corticosteroid injectable market was valued at approximately USD 3.4 billion in 2022.
- Compound annual growth rate (CAGR) from 2023 to 2028 projected at 4.5%.
- The United States accounts for roughly 60% of sales, driven by high adoption in hospitals and outpatient clinics.
Key competitors
- Pfizer (Depo-Medrol)
- Teva Pharmaceuticals (Methylprednisolone acetate)
- Sandoz (Sterile methylprednisolone acetate suspensions)
Market drivers
- Growing incidence of inflammatory and autoimmune conditions.
- Increased hospitalizations and outpatient procedures requiring corticosteroid injections.
- Off-label use in orthopedic procedures and pain management.
Regulatory factors
- FDA approved manufacturing of methylprednisolone acetate as a sterile injectable product.
- Several patents have expired, opening the market to biosimilars and generics.
What is the pricing trend?
Current average wholesale price (AWP)
- For 40 mg/mL methylprednisolone acetate injectable suspension, AWP ranges from USD 8.50 to USD 12 per vial.
- The average actual selling price (ASP) to hospitals and clinics is approximately USD 7.00 per vial.
Factors influencing price
- Patent expirations have increased generic competition, exerting downward pressure.
- Manufacturing costs for sterile injectables remain high, constraining drastic price reductions.
- Reimbursement policies by Medicare and Medicaid influence pricing strategies.
Historical price trend
| Year |
Average Price per Vial (USD) |
Notes |
| 2018 |
USD 12.00 |
Pre-patent expiration, high brand dominance |
| 2020 |
USD 9.50 |
Increased generic market entry |
| 2022 |
USD 8.50 – USD 12.00 |
Market stabilized with multiple suppliers |
What are the projections?
Price projections (2023-2028)
| Year |
Expected Price Range (USD per vial) |
Key Factors |
| 2023 |
USD 7.50 - USD 9.00 |
Continued generic competition; supply chain stabilization |
| 2024 |
USD 7.00 - USD 8.50 |
Market saturation; manufacturing efficiencies |
| 2025 |
USD 6.80 - USD 8.00 |
Regulatory pressures and potential biosimilar entries |
| 2026 |
USD 6.50 - USD 7.50 |
Ongoing price competition; potential price erosion |
| 2027 |
USD 6.20 - USD 7.00 |
Mature market with established generic suppliers |
| 2028 |
USD 6.00 - USD 7.00 |
Price stabilization at lower levels |
Market volume considerations
- Estimated annual utilization of methylprednisolone acetate in hospitals exceeds 20 million vials globally.
- The US market accounts for roughly 60% of this volume, with high-use cases in pain management, orthopedic surgeries, and autoimmune treatments.
Revenue implications for manufacturers
- High-volume sales at lower margins projected.
- Potential revenue decline as prices stabilize or decrease, but total volume could offset margin compression.
What are the key risks and opportunities?
Risks
- Increased biosimilar and generic entry could further depress prices.
- Regulatory changes might alter pricing or market access.
- Supply chain disruptions affecting availability and pricing.
Opportunities
- Expansion into emerging markets with growing healthcare infrastructure.
- Development of combination products or extended-release formulations to command premium pricing.
- Strategic partnerships for patent extensions or licensing.
Final thoughts
The market for methylprednisolone acetate injectable suspension remains competitive. Price erosion is expected over the next five years driven by increasing generic presence. Manufacturers should focus on cost containment, supply chain resilience, and exploring differentiation strategies, including indications beyond traditional uses.
Key Takeaways
- The drug under NDC 00113-0141, methylprednisolone acetate injectable suspension, is in a mature market with high competition.
- Prices have declined from approximately USD 12 in 2018 to USD 8.50-$12 in 2022, with further reductions projected.
- Market volume is substantial, especially in the US, but revenue growth may slow due to price compression.
- Opportunities exist in emerging markets and through product innovation.
- Risks include price pressure from biosimilars and regulatory shifts.
FAQs
1. What factors primarily influence the price of methylprednisolone acetate?
Patent expiration, generic competition, manufacturing costs, and reimbursement policies.
2. How does the US market compare to the global market for this drug?
The US accounts for approximately 60% of sales volume, with higher reimbursement rates but also more intense generic competition.
3. Are biosimilars entering the market for methylprednisolone acetate?
While biosimilars for methylprednisolone injections are developing, most competition currently comes from generic formulations.
4. What future market trends should investors monitor?
Emerging markets growth, biosimilar market penetrations, regulatory changes, and innovations in drug delivery.
5. What production considerations impact pricing?
Sterile injectable manufacturing involves high costs related to quality control, facility automation, and compliance, influencing final pricing and margins.
References
- MarketsandMarkets. (2022). Corticosteroids Market by Type, Application, End User, and Region.
- IQVIA. (2023). National Prescription Drug Utilization and Price Trends.
- U.S. Food and Drug Administration. (2023). Approved Sterile Injectable Drugs.
- Statista. (2023). Injection drug market size and forecasts.
- EvaluatePharma. (2022). 2022 World Preview: Oncology, Biosimilars, and Steroids.
