Last updated: February 13, 2026
What Is the Drug?
NDC 00597-0385 is identified as Amiodarone Hydrochloride Injectable, primarily used for managing life-threatening ventricular arrhythmias. It is a generic formulation, commonly available for hospital and clinical use.
Market Overview
Therapeutic Area and Demand Drivers
Amiodarone is a first-line antiarrhythmic for both inpatient and outpatient settings, especially for refractory ventricular arrhythmias and atrial fibrillation conversion. Its market demand reflects the prevalence of these conditions.
- Prevalence of atrial fibrillation: Estimated over 37 million globally, with increasing incidence among aging populations.
- Ventricular arrhythmias: Often linked to cardiac ischemia and heart failure, which collectively affect millions worldwide.
Market Size (2022-2023)
- The global antiarrhythmic drugs market valuation stands at approximately $3.2 billion in 2022.
- The injectable segment accounts for roughly 35%, driven by hospital use.
Competitive Landscape
- Several brand-name and generic manufacturers, including Teva, Sandoz, and Hikma.
- Patent status: Amiodarone's patent expired long ago, facilitating generic entry.
- Key differentiators: Formulation stability, delivery system, and price.
Pricing Dynamics
Historical Pricing Trends
- The average wholesale price (AWP) for a 150 mg/3 mL vial has ranged from $75 to $150.
- Institutional procurement prices are approximately 20-30% lower than AWP.
- Price variability relates to supplier, purchasing volume, and formulary negotiations.
Current Price Points
| Specification |
Average Price (USD) |
Notes |
| 150 mg/3 mL vial |
$90 - $120 |
Widely available |
| 300 mg/6 mL vial |
$150 - $200 |
Less common, higher dose |
Pricing Compared to Competitors
- Amiodarone injection remains competitively priced within the antiarrhythmic injectable market.
- No significant price inflation observed in recent years, mainly due to generic competition.
Price Projections (2024-2028)
Market Drivers Impacting Price
- Increased adoption for atrial fibrillation in outpatient and ambulatory settings under evolving guidelines.
- Hospital budgets tightening, pressuring suppliers to lower prices.
- Potential regulatory changes affecting drug dispensing and reimbursement.
Projection Assumptions
- Continued generic competition maintains stability or slight decrease in prices.
- No major supply disruptions or regulatory restrictions.
- Demand grows at 2-3% annually due to rising cardiovascular disease rates.
Forecasted Price Range
| Year |
Expected Price Range (USD) per 150 mg/3 mL vial |
Commentary |
| 2024 |
$85 - $115 |
Slight decrease as supply stabilizes |
| 2025 |
$80 - $110 |
Competitive pressure persists |
| 2026 |
$80 - $105 |
Market stabilization persists |
| 2027 |
$75 - $105 |
Marginal decline possible |
| 2028 |
$75 - $100 |
Prices plateau barring new market entrants |
Market Entrants and Impact
- Entry of biosimilars or alternative formulations could further compress prices.
- Hospitals adopting home infusion models may influence purchasing patterns.
Revenue Projections
- For a typical hospital dispensing approximately 10,000 units annually, revenue from NDC 00597-0385 could be roughly $900,000 to $1.2 million annually, assuming stable prices.
- If demand increases due to expanded use, revenues could rise proportionally.
Final Summary
The market for NDC 00597-0385 (Amiodarone Hydrochloride Injection) is mature, with stable generic competition keeping prices relatively low. Prices are projected to decline marginally over the coming five years, driven by ongoing competition and market saturation. Any significant shifts—regulatory, clinical, or competitive—could alter this outlook.
Key Takeaways
- NDC 00597-0385 is a generic Amiodarone injectable with stable demand in arrhythmia treatment.
- Current prices range from approximately $75 to $120 per 150 mg/3 mL vial.
- Market growth is modest, with demand increase driven by cardiovascular disease prevalence.
- Price projections suggest a slight decline, stabilizing between $75 and $100 over five years.
- Competitive pressures and regulatory changes could accelerate price adjustments.
FAQs
1. What factors influence amiodarone injectable prices?
Pricing is mainly affected by generic competition, hospital procurement contracts, supply chain dynamics, and regulatory policies.
2. How does NDC 00597-0385 compare price-wise to similar antiarrhythmic drugs?
It is generally more affordable due to multiple manufacturers competing in the injectable segment, maintaining prices below brand counterparts.
3. Are there upcoming regulatory changes that could impact this drug?
Possible changes include hospital formulary policies, reimbursement adjustments, or safety monitoring updates, but none are imminent.
4. What is the impact of new oral formulations on the injectable market?
Oral formulations mainly serve outpatient needs and do not significantly impact the hospital injectable segment but could influence overall demand.
5. How does supply chain stability affect prices?
Disruptions can lead to price increases; currently, supply is stable with multiple suppliers ensuring competitive pricing.
Citations:
[1] Global antiarrhythmic drugs market report, 2022.
[2] IQVIA. "Hospital Purchases of Injectable Antiarrhythmics," 2022.
[3] FDA. "Amiodarone Approved Uses and Label," 2023.
