Last updated: February 21, 2026
What is NDC 00574-4160?
The drug identified by NDC 00574-4160 is Methylprednisolone Acetate. It is a corticosteroid used to reduce inflammation in various conditions, including allergic reactions, skin diseases, asthma, and certain autoimmune disorders. The formulation is typically an injectable, with primary usage in hospital and outpatient settings.
Market Overview
Market Size and Demand
The corticosteroid market, including methylprednisolone formulations, was valued at approximately $2.6 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.5% through 2030, driven by increasing prevalence of autoimmune and inflammatory diseases and expanding outpatient procedures requiring corticosteroid injections.
Key Market Drivers
- Rising incidence of autoimmune diseases such as rheumatoid arthritis and multiple sclerosis.
- Growing adoption of corticosteroids in combination therapies.
- Expanding outpatient and hospital-based treatment procedures.
Competitive Landscape
Major competitors include Pfizer (Solu-Medrol), Teva Pharmaceuticals, Novartis, and Mylan. These companies dominate the market with established product lines, extensive distribution networks, and regulatory approvals globally.
Regulatory Status
The product is FDA-approved as a sterile, preservative-free methylprednisolone acetate injectable suspension. Production guidelines follow strict sterile manufacturing standards. Market entry for generic versions depends on patent expiry, with the original patent expiring in the late 2010s.
Pricing Analysis
Current Market Price
The average wholesale price (AWP) for methylprednisolone acetate injectable suspension (approximately 40 mg/mL vials) ranges from $15 to $25 per vial in the U.S., depending on the supplier, packaging, and contractual discounts.
Price Trends
- Brand Name (Solu-Medrol): Retail price approximately $20–$30 per 40 mg vial.
- Generic Versions: Price drops to $15–$20 per vial following patent expiry.
- Bulk/Institutional Purchases: Negotiated discounts can reduce per-vial costs by 20–30%.
Price Projection (Next 3-5 Years)
Given patent expiries and increased generic competition:
- Low-end estimate: Price decline to $10–$15 per vial by 2025.
- Moderate estimate: Stabilization around $12–$18 per vial, considering market consolidation and supply chain adjustments.
- High-end estimate: Slight increase or stabilization at current levels for specific formulations with limited competition.
Factors Influencing Future Prices
- Entry of biosimilars or alternative corticosteroid formulations.
- Consolidation or exit of generic manufacturers.
- Regulatory changes impacting import/export or compounding regulations.
- Supply chain disruptions impacting raw material costs.
Market Entry and Investment Opportunities
New entrants could leverage formulations with differentiated delivery (e.g., sustained-release suspensions). Market entry costs include regulatory approval, manufacturing scale-up, and establishing distribution channels. Price pressure from existing generics limits profit margins but offers opportunities for targeted niche therapies.
Summary
The corticosteroid injectable market, specifically methylprednisolone acetate, is mature with stable demand. Prices are trending downward due to generics, with potential stabilization around $12 per vial in the near term. Market entry requires navigating regulatory standards and competitive pricing while recognizing that the exposure to supply chain and regulatory risks remains significant.
Key Takeaways
- The drug’s market is dominated by generic products, with prices declining from brand-name levels.
- Demand remains steady, driven by autoimmune disease prevalence and procedural needs.
- Price projections indicate a decrease to approximately $10–$15 per vial over five years.
- Competition, regulatory changes, and supply chain dynamics influence future pricing.
- Opportunities exist in niche formulations and underserved markets.
FAQs
1. What is the primary therapeutic use of NDC 00574-4160?
It is used to treat inflammation and autoimmune conditions through corticosteroid injections.
2. How competitive is the market for methylprednisolone acetate?
Highly competitive due to multiple manufacturers and patent expiries resulting in multiple generic options.
3. What are the key factors affecting future pricing?
Generic competition, regulatory environment, and supply chain stability.
4. Are biosimilars a concern for this drug?
Biosimilars are generally not applicable as it is a small-molecule drug, but generic competition is robust.
5. What are the main opportunities for new players?
Introducing formulations with improved delivery or targeting niche indications may provide competitive advantages.
References
- IBISWorld. (2023). Corticosteroid Market in the US.
- GoodRx Health. (2023). Methylprednisolone Prices.
- FDA. (2016). Approval history of methylprednisolone acetate injectable suspension.
- EvaluatePharma. (2022). Global corticosteroid market analysis.
- IMS Health. (2022). Prescription trends for corticosteroids in the US.
