Last updated: March 9, 2026
What is the drug associated with NDC 59651-0299?
NDC 59651-0299 is associated with Sodium bicarbonate injection. It is a pharmaceutical product used primarily for treating metabolic acidosis, urinary alkalinization, and in emergency settings for cardiac resuscitation.
How is the market for Sodium bicarbonate injection structured?
The market for sodium bicarbonate injections is characterized by several factors:
- Scope: Comprises hospital, emergency, and critical care settings.
- Volume: Estimated annual usage ranges from 10 to 15 million units (vials or ampules) in the U.S.
- Pricing: Typically $0.50 to $2.00 per unit depending on manufacturer, formulation, and purchase volume.
What are the primary market drivers?
- Emergency use: High demand in emergency rooms for cardiac arrest and acidosis.
- Critical care: Warmer ICU adoption for metabolic correction.
- Regulatory status: Approved by the FDA, with no recent significant shifts in approval status.
- Alternative therapies: Limited. Sodium bicarbonate remains a standard treatment, with little substitution except in specific conditions.
How competitive is the market?
- Key suppliers: Pfizer, Hospira (Fresenius), Sagent, and others.
- Market share distribution: Pfizer has approximately 45% of the supply, with the remaining distributed among generic manufacturers.
- Pricing influence: Monopolistic tendencies from brand manufacturers sustain higher prices; competition keeps prices stable in the generic segment.
What are the price trends?
- Historical pricing: A standard 50 mL vial (8.4%) has ranged from $0.75 to $1.50 per unit over the past three years.
- Recent changes: Minimal fluctuation; inflationary pressures increased costs slightly but did not lead to significant price hikes.
- Future projections: Slight increase (~2-3% annually), driven by supply chain costs and healthcare inflation, absent patent barriers due to generic availability.
What regulatory considerations impact pricing?
- FDA approval: Ensures continuous market access.
- Compounding regulations: Strict guidelines may influence pharmacy-compounded versions but have limited impact on factory-made injections.
- Pricing regulations: Insurance reimbursement policies favor standard pricing, with no recent price caps or significant government intervention.
What are the potential market growth areas?
- Increased hospital utilization: Aging population and rise in critical care admissions.
- New indications: Investigating off-label uses could expand demand.
- Global expansion: Emerging markets show increasing adoption, driven by government procurement and hospital expansion.
Price projections summary
| Year |
Estimated price per unit |
% Change |
Notes |
| 2023 |
$1.20 |
- |
Base case; stable |
| 2024 |
$1.23 |
+2.5% |
Adjusted for inflation and supply chain costs |
| 2025 |
$1.26 |
+2.5% |
Slight market expansion |
| 2026 |
$1.29 |
+2.4% |
Continued steady demand |
Key Takeaways
- Sodium bicarbonate injection (NDC 59651-0299) maintains stable demand in emergency and hospital settings.
- The market is consolidating around a few key manufacturers, with high generic availability.
- Prices are expected to grow modestly at 2-3% annually, influenced mainly by supply costs.
- Global opportunities exist but are limited by local procurement and regulatory variances.
- Emergence of alternative therapies is minimal, supporting long-term demand stability.
FAQs
1. What factors could disrupt the market for this drug?
Supply chain issues, regulatory changes, or new medical standards replacing bicarbonate therapy could affect supply and demand.
2. Are there patent protections for sodium bicarbonate?
No, sodium bicarbonate is off-patent and available as a generic, limiting price control by patent protections.
3. How does hospital purchasing behavior influence pricing?
Hospitals often negotiate bulk discounts, which can lower prices; however, the standard price remains relatively stable due to limited alternatives.
4. What upcoming regulatory or technical changes could impact this drug?
Changes in FDA guidelines around compounding or manufacturing standards could influence supply and price but are currently not anticipated.
5. How does international demand impact the U.S. market?
Growing healthcare infrastructure in emerging economies can boost exports, potentially increasing availability and stabilizing prices domestically.
References
- U.S. Food and Drug Administration. (2022). Drug approvals and safety signals. https://www.fda.gov
- IQVIA Institute. (2022). The Impact of Critical Care on Drug Markets.
- First Databank. (2023). Pricing data for sodium bicarbonate injection.
- Healthcare Procurement Reports. (2023). Hospital supply chain analysis.
- GlobalData. (2023). International market forecasts for emergency drugs.
