Last updated: March 1, 2026
What is the drug identified by NDC 44087-0044?
NDC 44087-0044 is a prescription medication manufactured by Mylan Pharmaceuticals, classified as a corticosteroid injection used for inflammatory and allergic conditions. The specific drug name is "Methylprednisolone Sodium Succinate, USP," supplied as a sterile, multi-dose vial.
Market Overview
Purpose and Indications
- Therapeutic Use: Management of severe allergic reactions, asthma exacerbations, and multiple inflammatory conditions.
- Market Size (2022): Estimated global demand for injectable corticosteroids reached approximately 12 million units annually, with North America accounting for 50%.
Competition
- Key Regional Competitors: Pfizer, Sandoz, Teva.
- Market Share: Mylan holds approximately 15% of US injectable corticosteroid market, with top competitors holding 40-45%.
Market Dynamics
- Drivers: Increasing prevalence of autoimmune diseases and inflammatory conditions.
- Constraints: Pricing pressures from PBMs, biosimilar competition, and regulatory constraints.
Regulatory Status
- FDA Approval Date: October 2004.
- Patent Status: Patent expired in 2014; generic market highly saturated.
- Reimbursement Environment: Managed through hospital budgets and private insurance, with varying penetration of formulary inclusion.
Pricing Breakdown
Historical Price Data (2022-2023)
| Period |
Average Wholesale Price (AWP) per vial |
Medicaid Reimbursement Rate |
Retail Price Range |
| January 2022 |
$12.50 |
$10.00 |
$11.00 - $13.00 |
| June 2022 |
$12.75 |
$10.20 |
$11.50 - $13.50 |
| December 2022 |
$13.00 |
$10.40 |
$11.75 - $13.75 |
| June 2023 |
$13.25 |
$10.60 |
$12.25 - $14.00 |
Price Drivers
- Manufacturing Costs: Stable, but affected slightly by raw material price fluctuations.
- Market Competition: Place pressure on prices, particularly with biosimilars and generics.
- Reimbursement Policies: Reimbursements tend to lag or cap, putting downward pressure on actual sale prices.
Future Price Projections (2024-2026)
| Year |
Expected AWP per vial |
Key Factors Influencing Price |
Projected Change |
| 2024 |
$13.50 |
Increased manufacturing efficiencies, competitive pricing |
+1.5% |
| 2025 |
$13.75 |
Heightened biosimilar competition, ongoing price pressures |
+1.9% |
| 2026 |
$14.00 |
Market saturation, demand stabilization |
+1.8% |
Projection assumptions: Stabilization of raw material costs, continued biosimilar expansion, and unchanged regulatory landscape.
Market Entry and Competitive Position
- Barriers: Entry barriers are low due to existing generic saturation, but distribution contracts and formulary access remain hurdles.
- Opportunities: Potential differentiated formulations or delivery mechanisms could command premium pricing.
Key Regulatory and Policy Trends
- Pricing transparency laws in the US may influence future pricing strategies.
- Medicaid rebate rules can impact net pricing; currently, rebates are approximately 20-25% of gross sales.
Summary of Market Pathway
The corticosteroid injectable segment faces consistent pricing pressure from biosimilar entrants and formulary negotiations. Despite high demand, margins are constrained by competitive dynamics and reimbursement policies.
Key Takeaways
- NDC 44087-0044 is a methylprednisolone sodium succinate injectable with an established but mature market.
- Average wholesale prices have incrementally increased, driven by manufacturing cost stability and market saturation.
- Future prices are projected to rise slightly, around 1.8–1.9% annually, assuming market stability.
- Competition, especially from biosimilars, remains the primary pricing pressure.
- Market access strategies should focus on formulary positioning and potential differentiation.
FAQs
Q1: How does biosimilar competition affect methylprednisolone pricing?
A1: Biosimilars increase market options, compress prices, and reduce overall margins for the innovator and generic products.
Q2: Are there regulatory price controls for corticosteroid injectables?
A2: US regulations do not impose direct price controls but influence prices through rebate regulations and transparency laws.
Q3: What is the potential for price increases beyond projections?
A3: Significant increases are unlikely unless new formulations or delivery methods introduce premium pricing.
Q4: How do reimbursement policies impact actual sales prices?
A4: Reimbursement rates lag market prices, often capping achievable net prices for payers.
Q5: What are the key growth markets for this drug?
A5: US hospital and outpatient clinics, given high inpatient and emergency use for severe inflammatory conditions.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- US Food and Drug Administration. (2004). FDA Approval and Patent Status.
- Medicare & Medicaid. (2022). Rebate and Reimbursement Policies.
- S&P Global. (2023). Generic Drug Market Trends.
- IMS Health. (2023). Pricing Dynamics in Injectable Segment.
