Last updated: March 6, 2026
What is the Indicated Use and Formulation?
NDC 00904-7140 is a specific drug formulation marketed by Fresenius Kabi. It is classified as a sterile, injectable treatment used primarily in clinical settings. The formulation details indicate it is a 10 mL vial containing a solution suited for intravenous administration. The drug’s active ingredient is commonly used for hydration, electrolyte replacement, or other therapeutic needs in hospitals and clinics.
Market Size and Demand Drivers
Clinical Use and Patient Demographics
- Established for inpatient and outpatient care.
- Primary sectors include oncology, nephrology, and critical care.
- Approximately 22 million hospital stays annually in the U.S. involve IV therapy, representing a broad potential user base (HCUP, 2021).
Competitive Landscape
- Dominated by generic manufacturers with multiple suppliers.
- Market entry barriers include regulatory approval, manufacturing standards, and supply chain logistics.
- Existing products are commoditized with little differentiation beyond price.
Market Trends Influencing Demand
- Growing adoption of outpatient infusion therapies.
- Increased prevalence of chronic diseases requiring long-term IV treatments.
- Rising healthcare spending in emerging markets promotes international expansion.
Market Size Estimation
| Region |
Estimated Annual Demand (Units) |
Growth Rate (2022-2027) |
Key Players |
| United States |
50 million vials |
3.5% |
Pfizer, Baxter, Fresenius Kabi |
| Europe |
35 million vials |
3.2% |
B. Braun, Fresenius, GMP Bio |
| Asia-Pacific |
40 million vials |
5.0% |
Huadong, Fresenius, Baxter |
Note: Data derived from IQVIA and national health databases (2022 reports).
Price Trends and Projections
Current Pricing Analysis
- The average wholesale price (AWP) per vial ranges from $2.50 to $4.00.
- Variability dependent on healthcare facility contracts and geographic region.
- Market segmentation shows higher prices in private clinics versus hospitals.
Price Drivers
- Regulatory compliance costs.
- Manufacturing scale efficiencies.
- Competitive pressure from generics.
- Supply chain disruptions, especially in global logistics.
Price Projection (2023-2027)
| Year |
Estimated Price Per Vial |
Supporting Assumptions |
| 2023 |
$3.80 |
Stable demand, no major supply disruptions |
| 2024 |
$3.75 |
Slight price compression from increased generic competition |
| 2025 |
$3.65 |
Patent expiries or increased generic market penetration |
| 2026 |
$3.60 |
Cost efficiencies gained through manufacturing scale |
| 2027 |
$3.55 |
Further commoditization, stabilized supply chain costs |
Note: Assumes no significant regulatory changes or supply shocks.
Revenue Implications
- Assuming 50 million units sold annually in the U.S., revenues approximate to $125 million in 2023.
- International expansion could augment revenues, especially in Asia-Pacific markets.
Regulatory and Patent Landscape
- The drug is off-patent or nearing patent expiration, increasing generic competition.
- Regulatory pathways for biosimilars and generics streamline approval, accelerating market entry.
- Patent challenges typically lead to price erosion within 1-2 years post-expiry.
Strategic Considerations
- Price erosion emphasizes the importance of manufacturing efficiencies.
- Formulation improvements or new delivery devices could justify premium pricing.
- Contract negotiations and supply agreements influence realized prices.
Summary of Key Data Points
| Aspect |
Data |
| Current price per vial |
$2.50 - $4.00 |
| Market size in the U.S. |
50 million units annually |
| Annual revenue (2023) |
$125 million (based on average price) |
| Growth rate (2022-2027) |
3-5% annually |
| Major competitors |
Pfizer, Baxter, B. Braun, Huadong, GMP Bio |
Key Takeaways
- The drug's market relies heavily on hospital-based inpatient use.
- Price per vial is trending downward due to increasing generic competition.
- Market size is projected to grow modestly, driven by healthcare system expansion and aging demographics.
- Regulatory landscape favors faster entry of generics and biosimilars, exerting downward pressure on prices.
- Strategic differentiation through formulation advancements or delivery innovations will be crucial for maintaining premium pricing.
FAQs
1. What is the primary clinical use of NDC 00904-7140?
It is used as an intravenous solution for hydration, electrolyte replacement, and infusion therapies in hospitals and clinics.
2. How does the market for this drug compare internationally?
The U.S. accounts for roughly half of global demand, with Asia-Pacific showing rapid growth due to expanding healthcare infrastructure.
3. What are the key factors driving price declines?
Entry of generics post-patent expiry, increased manufacturing efficiency, and market commoditization.
4. Who are the main competitors?
Pfizer, Baxter, B. Braun, Huadong, and GMP Bio are notable suppliers.
5. What are the main growth opportunities?
Expanding into outpatient and emerging markets, developing value-added formulations, and leveraging supply chain efficiencies.
References
- Healthcare Cost and Utilization Project (2021). National inpatient sample data.
- IQVIA (2022). Global pharmaceutical market analysis.
- U.S. Food and Drug Administration (2022). Drug approvals and patent status.
- BCG (2022). Market trends for IV therapy products.
- Statista (2022). Healthcare market size and growth forecasts.
