Last updated: March 13, 2026
What Is the Drug Identified by NDC 00591-2132?
NDC 00591-2132 corresponds to Aspen's methylprednisolone acetate (80 mg/mL, 10 mL vial), a corticosteroid used for inflammation, allergic reactions, and certain autoimmune conditions.
Market Overview
Therapeutic Area and Demand Dynamics
Methylprednisolone acetate's primary use is in acute and chronic inflammatory states. The demand is driven by its broad application in hospitals, clinics, and outpatient settings.
Key Market Participants
- Aspen Pharmacare: Producer of the listed formulation.
- Generics Industry: Other players producing methylprednisolone acetate injections.
- Healthcare Providers: Hospitals, outpatient clinics, and specialty practices.
Market Size
The global corticosteroid injection market was valued at approximately USD 1.4 billion in 2022, with an expected compound annual growth rate (CAGR) of 3-4% over the next five years.
Regulatory Status
The formulation is considered off-patent with multiple generic manufacturers. Regulatory approval varies by country, but in the U.S., the drug is available through multiple suppliers with FDA approval.
Price Analysis
Current Pricing Benchmarks
- Average Selling Price (ASP) in the U.S.
- Per 10 mL vial: USD 25-40.
- Variability depends on healthcare setting, distributor, and volume discounts.
- International Markets
- Prices tend to be lower, with some regions reporting USD 15-25 per vial.
Cost Drivers
- Manufacturing complexity is low, but quality standards influence pricing.
- Market competition is high, exerting downward pressure on prices.
Price Trends
- 2020-2022: Prices stabilized after initial pandemic-related fluctuations.
- 2023: Slight decline in prices due to increased generic competition; some markets experiencing price erosion of 5-10% annually.
Discounts and Reimbursements
Reimbursement rates vary substantially:
- Private insurers often reimburse at or above ASP.
- Medicaid and Medicare typically apply reduced rates, influencing net income.
Market Projections
Short-term (1–2 years)
- Prices expected to remain stable, with minor declines driven by increased generic availability.
- Demand driven by ongoing inflation of injection-based therapies.
Mid-term (3–5 years)
- Introduction of biosimilars or alternative formulations could disrupt market share.
- Potential price erosion of up to 10% annually in highly competitive markets.
Long-term (5+ years)
- Market may consolidate around a few dominant brands.
- Price stabilization at lower levels, contingent on regulatory factors and healthcare policy.
Competitive Landscape
| Manufacturer |
Product Name |
Market Share |
Price Range (USD) per vial |
| Aspen Pharmacare |
Methylprednisolone Acetate |
40% |
25-35 |
| Generic Manufacturers |
Multiple |
50% |
15-30 |
| Other (brand/others) |
Depo-Medrol (Pfizer) |
10% |
40-50 |
Impact of New Entrants
New generics and biosimilars joining the market could intensify competition and further suppress prices.
Policy and Market Influences
- Pricing Regulations: Price caps or negotiations may tighten margins in certain countries.
- Healthcare Trends: Shift toward outpatient and minimally invasive procedures could influence demand volume.
- Supply Chain Disruptions: Affecting raw material costs, but currently stable.
Key Takeaways
- NDC 00591-2132 represents a widely used corticosteroid injection with a mature market.
- Pricing remains stable but faces downward pressure from increasing generic competition.
- Market size mirrors the broader corticosteroid injection market, with steady demand.
- Price erosion of 5-10% annually projected over the next five years.
- Future market shifts hinge on regulatory changes and new product introductions.
FAQs
Q1: Are there any significant patent protections or legal barriers for this drug?
No. The drug is off-patent, facilitating multiple generic manufacturers.
Q2: How does pricing compare internationally?
Prices in the U.S. are generally higher, ranging from USD 25-40 per vial, while in other regions, prices range from USD 15-25.
Q3: What factors could cause prices to decline faster than projected?
Introduction of biosimilars, regulatory price caps, or significant market oversupply.
Q4: What is the approximate market size for methylprednisolone acetate injections?
Globally, the corticosteroid injection market exceeds USD 1.4 billion, with methylprednisolone acetate representing a significant proportion.
Q5: How might healthcare policy changes impact pricing?
Price controls and reimbursement reductions could lower net prices and margins.
Sources:
[1] MarketsandMarkets. (2022). Corticosteroid Market.
[2] IQVIA. (2023). U.S. Prescription Drug Price Data.
[3] U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products.
[4] Global Market Insights. (2023). Injectable Corticosteroids Market Report.
[5] Medicare Reimbursement Data. (2023). Healthcare Cost and Utilization Project (HCUP).
