Last updated: February 13, 2026
What is the drug associated with NDC 00078-0609?
NDC 00078-0609 corresponds to Methylprednisolone Sodium Succinate for Injection, USP, supplied by PFIZER. It is a corticosteroid used primarily for severe inflammation, allergic reactions, and autoimmune conditions. The drug is available in various dosages and formulations, mainly as a sterile powder for reconstitution.
What is the current market landscape?
Market Size and Demand
- The corticosteroid injectable segment, including methylprednisolone formulations, is valued at approximately $350 million in the U.S. (2022).
- The segment exhibits a compound annual growth rate (CAGR) of roughly 4.2% from 2021 through 2026.
- The demand increased during COVID-19 for severe inflammatory cases, but has stabilized post-pandemic.
Competitive Environment
- Market is dominated by Pfizer, Sandoz, and Teva with market shares of approximately 50%, 25%, and 15%, respectively.
- Key competitors include methylprednisolone acetate (Depo-Medrol), hydrocortisone, and dexamethasone formulations.
- Patent expirations of branded methylprednisolone products occurred in the last five years, elevating generic market share.
Regulatory and Market Trends
- Acceptance of biosimilars is limited as methylprednisolone is predominantly manufactured as small-molecule steroids.
- COVID-19 highlighted the importance of corticosteroids, but recent shortages in supply chains could influence availability.
- FDA approval for additional indications remains a potential growth driver.
How is price evolving?
Historical Pricing
- Average wholesale price (AWP) for a 40 mg vial: $30 - $40.
- Present average wholesale unit price: $35 per vial.
- Patient out-of-pocket costs are approximately $10 - $15 per vial, depending on insurance.
Price Trends
- Prices have remained relatively stable over the past three years.
- Slight reductions are observed due to increased generic competition.
- Price elasticity is low; demand remains steady as off-label and on-label uses are essential.
What are future price projections?
| Year |
Expected Wholesale Price per Vial |
Remarks |
| 2023 |
$34 |
Current market stability |
| 2024 |
$33.50 |
Slight downward pressure from increased generic supply |
| 2025 |
$33 |
Continued generic competition reduces pricing |
| 2026 |
$32.50 |
Potential volume growth offsets slight price decline |
Factors impacting future prices
- Regulatory changes: Accelerated approvals or new indications could increase demand.
- Supply chain stability: Shortages or manufacturing disruptions could cause price spikes.
- Market entry of biosimilars or generics: Greater competition could lower prices.
- Reimbursement policies: Changes in insurance coverage or Medicaid rebates could influence net prices.
Summary
The corticosteroid injectable market, specifically methylprednisolone, stabilizes with modest competition. Pricing per vial is expected to decline slightly, with prices dropping from approximately $35 to about $32.50 over the next three years, reflecting generic competition and volume-based negotiations.
Key Takeaways
- NDC 00078-0609 links to Pfizer's methylprednisolone sodium succinate injection.
- The market size was ~$350 million with steady demand, mainly saturated by generic competitors.
- Current prices hover around $35 per vial, with a trend toward gradual decrease.
- Price projections estimate a slow decline to approximately $32.50 by 2026.
- Market dynamics include competitive pressures, supply chain considerations, and regulatory shifts.
Frequently Asked Questions
1. How does the generic market impact prices for NDC 00078-0609?
Generic entry usually leads to price reductions. As more manufacturers obtain approval, competition intensifies, lowering wholesale and retail prices.
2. What is the market potential for new indications?
Additional indications could expand usage, especially if supported by FDA approval, potentially stabilizing or increasing prices due to higher demand.
3. Are supply shortages likely to affect prices?
Yes. Manufacturing disruptions or raw material constraints can temporarily raise prices. Continuous supply chain monitoring is essential.
4. How does insurance coverage influence retail prices?
Insurance and Medicaid rebates reduce out-of-pocket costs for patients, but reimbursement rates influence net revenue for providers and manufacturers.
5. What is the outlook for biosimilars or enhanced formulations?
Currently, biosimilars are less relevant for small molecules like methylprednisolone. Future formulations offering improved stability or administration could impact market share and pricing.
Sources
- IQVIA, "Pharmaceutical Market Reports," 2022.
- U.S. Food and Drug Administration, "Drug Approvals and Labeling," 2022.
- GoodRx, "Price Trends for Steroid Injectable Drugs," 2022.
- Fast Healthcare Interoperability Resources (FHIR) Data, "NDC Directory," 2023.
- MarketWatch, "Steroid Market Analysis," 2023.
