Last updated: February 20, 2026
What is NDC 00597-0285?
NDC 00597-0285 is a drug identified by the National Drug Code (NDC) as Solu-Medrol (methylprednisolone sodium succinate) for injection, 40 mg/mL. It is a corticosteroid used in various acute and chronic inflammatory conditions, including allergic reactions and autoimmune diseases.
Market Size and Demographics
Indications and Utilization
- Indications: Severe allergic reactions, asthma exacerbations, multiple sclerosis, and other inflammatory conditions.
- Usage Estimates (2022): Approximately 3.2 million units sold annually in the U.S.
- Prescriber Base: Mainly hospital-based, with primary users being emergency departments, intensive care units, and specialty clinics.
Market Players
- Manufacturers: Pfizer (original) now supplied by numerous generic manufacturers like Teva, Mylan, and Sandoz.
- Generic Penetration: Over 75% of the market is served by generics, driving prices downward.
Distribution Channels
- Hospital pharmacies account for roughly 60% of sales.
- Outpatient and retail channels constitute the remaining 40%.
Competitive Landscape
| Company |
Market Share (2022) |
Price Range (per 100 mL vial) |
Notes |
| Pfizer |
25% |
$35 - $45 |
Original brand; declining sales |
| Teva |
40% |
$20 - $30 |
Largest generic provider |
| Sandoz |
15% |
$22 - $28 |
Growing distribution |
| Others |
20% |
$19 - $35 |
Fragmented market |
Price Trends and Projections
Current Price Dynamics
- Average Wholesale Price (AWP): $25 per 100 mL vial.
- Average Selling Price (ASP): ~$21 per vial in hospitals.
- Discounts: Hospitals and pharmacy benefit managers (PBMs) negotiate discounts of up to 25–35%.
Market Drivers
- Increased adoption of generics reduces prices.
- Supply chain stability influences pricing; shortages in 2021 caused temporary price hikes.
- Regulatory pressure encourages price transparency.
Future Price Trends (Next 3 Years)
| Year |
Predicted Average Price (per 100 mL vial) |
Comments |
| 2023 |
$20 - $24 |
Continued generic competition; stabilizing prices |
| 2024 |
$19 - $23 |
Potential slight decline; increased market saturation |
| 2025 |
$18 - $22 |
Regulatory impacts and procurement efficiency further reduce costs |
Assumptions Underpinning Projections
- Market maintains current competitive dynamics.
- No major regulatory or patent issues disrupt supply.
- No significant increases in demand or shortages.
- Price declines due to further generic penetration and increased procurement efficiency.
Key Market Risks
- Supply chain disruptions (e.g., COVID-19 impacts).
- Regulatory changes affecting pricing transparency.
- Potential patent or exclusivity challenges.
- Fluctuations in overall healthcare spending and hospital budgets.
Summary of Pricing and Market Outlook
The market for NDC 00597-0285 is mature, with significant generic penetration that has driven prices downward over the past five years. Prices are expected to trend slightly lower over the next three years, barring major supply or regulatory shocks. Current ASPs are approximately $21 per vial, with prospects for continued decline to around $18–$20 by 2025.
Key Takeaways
- The drug has a broad hospital-based market, with generics controlling most of the sales.
- Pricing is under pressure from increased competition and procurement efficiencies.
- Short-term stabilization is likely, with gradual declines predicted over three years.
- Supply chain stability remains a critical factor influencing prices.
- Regulatory and legislative policy shifts could significantly alter future pricing dynamics.
FAQs
1. How does the pricing of NDC 00597-0285 compare with other corticosteroids?
It is comparable to other generic injectable corticosteroids, generally priced between $18 and $30 per 100 mL vial, depending on manufacturer and volume discounts.
2. What factors could cause sudden price increases?
Supply shortages, manufacturing disruptions, or regulatory changes that limit product availability.
3. What is the role of branded Solu-Medrol in the current market?
Branded Solu-Medrol accounts for less than 25% of sales, with most hospitals opting for cheaper generics.
4. How do hospital procurement policies influence prices?
Hospitals negotiate bulk discounts through group purchasing organizations which can reduce prices by 20–30%.
5. Are there any upcoming patent or exclusivity issues for this drug?
As a well-established generic, patent protections are expired, but additional exclusivity is unlikely.
References
[1] IQVIA. (2022). National Prescription Audit.
[2] FDA. (2022). Drug Approvals and Labeling.
[3] Red Book. (2022). Pharmaceutical Pricing and Market Data.
[4] Reports and data compiled from industry market assessments, 2022–2023.
