Last updated: February 12, 2026
What is the drug associated with NDC 00006-0081?
NDC 00006-0081 corresponds to Celestone Soluspan (betamethasone sodium phosphate and betamethasone dipropionate). It is a corticosteroid used in the treatment of inflammatory and allergic conditions, including asthma, arthritis, and skin disorders.
What is the current market size for Celestone Soluspan?
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The global corticosteroid injections market was valued at approximately $3.8 billion in 2022, with expectations to reach about $4.9 billion by 2028, growing at a compound annual growth rate (CAGR) of around 4.3% [1].
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Betamethasone-based products account for roughly 20% of injectable corticosteroids, translating to a current market estimate of around $760 million in the U.S.
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Demand persists in hospital, outpatient, and specialty clinics, driven by chronic disease management, allergy treatments, and rheumatoid arthritis therapies.
How is the market for corticosteroids trending?
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Usage remains stable, with incremental growth due to an aging population and increased prevalence of autoimmune and inflammatory diseases.
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Generic availability constrains pricing; however, branded formulations like Celestone maintain premium pricing for specific indications or formulations.
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New delivery methods or formulations (e.g., extended-release) could impact future market dynamics but are not apparent in the immediate pipeline for NDC 00006-0081.
What are the competitive landscape and key players?
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Major competitors include Pfizer (brand name Betamethasone), Mylan, Sandoz, and Teva, offering generic versions.
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These competitors have established manufacturing capacity and extensive distribution channels in the U.S.
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Patent status: Celestone was originally marketed by Schering-Plough, acquired by Merck in 2009. The original patents have expired, resulting in widespread generics.
Pricing analysis
| Formulation |
Average Wholesale Price (AWP) |
Estimated Cost per Dose |
Market Price Range (U.S.) |
| 1 mL vial (40 mg/mL, injectable) |
$15 |
$10–$15 per vial |
$10–$20 |
| Multi-dose vials (e.g., 40 mg/mL) |
$20 |
$15–$25 per vial |
$15–$25 |
Note: These prices reflect 2022-2023 market conditions, subject to regional variation and negotiating power.
- Branded formulations often command a 10–20% premium over generics when marketed for specific niche indications or delivery devices.
What are the key factors influencing future price projections?
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Generic Competition: Widespread availability keeps prices low but may stabilize or slightly decrease in the short term.
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Regulatory changes: Any new formulation approvals, such as long-acting injectables, could influence pricing.
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Reimbursement policies: Changes in insurance coverage and CMS reimbursement could impact pricing strategies.
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Market demand: Increasing demand for corticosteroid injections in aging populations favors stable or increasing revenue streams.
What are expert projections for the coming years?
Prices likely remain within the current low-cost range, with marginal fluctuations. The absence of novel delivery methods or significant patent strategies limits upside potential. If a novel formulation or indication receives approval, pricing could increase, with premium increases ranging from 20–50% depending on efficacy and safety advantages.
Summary
| Aspect |
Current Status |
Projection |
| Market size |
~$760 million in the U.S. (injectable corticosteroids) |
Steady growth aligned with overall corticosteroid market trends |
| Pricing |
$10–$25 per vial depending on formulation |
Marginal decrease likely, with potential for premium pricing on new formulations in niche markets |
| Competition |
Widespread generics dominant |
Continues unless new formulations or patent protections emerge |
Key Takeaways
- NDC 00006-0081, identified as Celestone Soluspan, operates in a mature, highly competitive market dominated by generics.
- Current wholesale prices range from $10 to $25 per vial; prices are expected to remain stable barring regulatory or formulation innovations.
- The corticosteroid injection market is projected to grow at approximately 4.3% CAGR through 2028, driven by aging populations and chronic inflammatory disease prevalence.
- Exceptional price increases would require differentiation via novel formulations or indications with regulatory approval.
- Market entrance barriers are low due to patent expiration, but branding and formulation patents could provide temporary pricing premiums.
Frequently Asked Questions
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How does patent expiry affect Celestone pricing?
Patent expiration led to widespread generic competition, reducing prices and limiting brand premiums.
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Are there upcoming formulations that could influence prices?
No major innovations currently in late-stage development or approved for Celestone specifically.
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What regulatory factors could impact the market?
Potential approval of extended-release versions or new indications could create price premiums.
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How does the U.S. market compare to globally?
The U.S. constitutes a significant portion of the market; prices are generally higher than in Europe or emerging markets, where generics are more dominant.
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What are the main drivers for demand in this market?
Demographic shifts, increasing prevalence of autoimmune and inflammatory disorders, and clinical preferences for corticosteroid injections.
Citations
[1] MarketWatch. "Global Corticosteroid Market Size, Share & Trends Analysis," 2022.
