Last updated: February 25, 2026
What is the drug associated with NDC 00113-0946?
The National Drug Code (NDC) 00113-0946 corresponds to Methylprednisolone Sodium Succinate for Injection, 40 mg per vial. It is a corticosteroid used to reduce inflammation and suppress immune responses in various medical conditions, including allergic reactions, severe asthma, and autoimmune diseases.
Market Overview
Indications and Usage
Methylprednisolone Sodium Succinate injections are used for acute management of conditions requiring rapid corticosteroid action. The drug's formulation is suitable for intravenous or intramuscular administration, making it a critical medication during hospitalizations and emergency situations.
Competitive Landscape
The corticosteroid market features several key players:
- Pfizer (brand: Solu-Medrol)
- Novartis (brand: Depo-Medrol, although primarily methylprednisolone acetate)
- Mylan (generic equivalents)
- Teva Pharmaceuticals
- Sandoz
The primary competitor to NDC 00113-0946 is Pfizer’s Solu-Medrol, which holds a significant market share due to established brand recognition and broad distribution.
Market Size and Trends
The global corticosteroids market was valued at approximately USD 7 billion in 2022; the injectable segment, especially high-dose methylprednisolone, accounts for about 25% of the total. Growth is driven by rising autoimmune and inflammatory disease prevalence, increased hospitalizations, and off-label uses.
In the U.S., the drug’s demand is driven by hospitals, emergency departments, and outpatient clinics. The total annual volume for methylprednisolone injections is estimated at around 4 million units, with hospital sales constituting 70%.
Pricing Dynamics
Traditionally, the injectable corticosteroid market has high price stability but faces pressure from generic manufacturers. Generic versions have reduced prices by approximately 20-30% since patent expirations (not applicable here, as Solu-Medrol’s patent expired in 2007). Manufacturing and distribution costs influence pricing.
Price Projections
Current Pricing Data
| Source |
Price per Vial (USD) |
Notes |
| Wholesale Acquisition Cost (WAC) |
USD 14–16 |
For brand-name Solu-Medrol |
| Average Actual Transaction Price |
USD 10–12 |
Negotiated discounts with hospitals |
| Generic Versions (e.g., Mylan) |
USD 6–8 |
Under generic competition |
Price Trends (Next 3-5 Years)
- Stability Expected: Due to high clinical demand and limited patent protection for the brand, prices are likely to remain stable within current ranges.
- Potential for Slight Decrease: Increased generic competition may push prices downward by an additional 10-15% over the next 3 years.
- Impact of Supply Chain Factors: Short-term price fluctuations could occur because of supply disruptions, raw material shortages, or regulatory changes affecting manufacturing.
Forecasted Pricing
| Year |
Predicted Price per Vial (USD) |
Rationale |
| 2023 |
USD 10–12 |
Current market conditions |
| 2024 |
USD 9–11 |
Slight decline due to generic competition |
| 2025 |
USD 8.50–10 |
Continued generic market penetration |
| 2026 |
USD 8–9 |
Market stabilization after competitive pressure |
Revenue Estimates
Assuming a conservative annual volume of 4 million units in the U.S., revenue streams are estimated as:
- 2023: USD 40-48 million
- 2024: USD 36-44 million
- 2025: USD 34–40 million
- 2026: USD 32–36 million
These projections assume consistent demand and no major regulatory or supply chain disruptions.
Regulatory Considerations
- No recent patent protection extends beyond 2007, leaving the market open to generics.
- FDA approval for biosimilar or alternative formulations could influence pricing.
- Price controls in certain markets or hospitals could suppress prices further.
Key Takeaways
- NDC 00113-0946 corresponds to Methylprednisolone Sodium Succinate for Injection, 40 mg.
- The drug is in a mature market with high generic penetration.
- Current average wholesale prices are approximately USD 10–12 per vial.
- Prices are expected to decline slightly over the next 3-5 years due to increased generic competition.
- Annual revenues in the U.S. are projected between USD 32 million and USD 48 million, depending on volume and price adjustments.
FAQs
-
What is the primary competitor to NDC 00113-0946?
Pfizer’s Solu-Medrol remains the leading brand, with several generic manufacturers offering similar formulations.
-
How do supply chain issues influence pricing?
Disruptions can cause temporary price increases or shortages, which may influence wholesale and retail prices.
-
Are biosimilars or new formulations expected to impact this market?
Biosimilar development is unlikely given the small molecule nature of methylprednisolone; however, new formulations could.
-
What regional factors affect pricing?
Government pricing regulations, hospital procurement policies, and market share can vary significantly across regions.
-
Will generic entry continue to lower prices?
Yes; increased generic competition typically exerts downward pressure on prices, especially within mature markets.
References
[1] IQVIA. (2022). Pharmaceutical Market Size and Trends.
[2] FDA. (2022). Approved Drugs Database.
[3] MarketDataForecast. (2022). Global Corticosteroids Market Analysis.
[4] Centers for Medicare & Medicaid Services. (2022). Pricing Data and Trends.
