Last updated: March 8, 2026
What is NDC 63304-0924?
NDC 63304-0924 refers to a specific drug product listed in the National Drug Code (NDC) database. It is a cardiac medication belonging to the class of antiarrhythmics. Based on available data, it is identified as Amiodarone hydrochloride infusion, commonly used for severe arrhythmias.
Market Size and Demand
Current Market Overview
- Therapeutic use: Treatment of ventricular arrhythmias, atrial fibrillation, and embolic conditions.
- Market size: Estimated global antiarrhythmic drug market valued at approximately USD 3.8 billion in 2022.
- Key regions: North America accounts for around 45% of total sales, Europe 30%, Asia-Pacific 15%, and rest of the world 10%.
Market Drivers
- Rising incidences of atrial fibrillation and ventricular arrhythmias due to aging populations.
- Increased adoption of implantable cardioverter defibrillators (ICDs), complemented by pharmacological management.
- Growing awareness and better screening of cardiac arrhythmias.
Market Challenges
- Side effects associated with amiodarone (e.g., pulmonary toxicity, thyroid issues).
- Competition from newer antiarrhythmic agents and ablation therapies.
- Strict regulatory standards affecting drug approval and post-market surveillance.
Competitive Landscape
Top competitors include:
| Company |
Product Name |
Market Share |
Price Range (USD per unit) |
| Pfizer |
Cordarone (brand) |
35% |
30-50 per vial |
| Mylan (now part of Viatris) |
Generic Amiodarone |
25% |
10-25 per vial |
| Teva Pharmaceuticals |
Generic Amiodarone |
20% |
12-20 per vial |
| Others |
Various generics |
20% |
8-15 per vial |
Pricing Trends and Projections
Historic Price Trends (2018-2022)
- The average wholesale acquisition cost (WAC) for amiodarone 150 mg/3 mL vials has decreased from USD 40 in 2018 to USD 20 in 2022, reflecting increased generic competition.
- Contract prices (e.g., Medicaid and hospital procurement) are approximately 10-50% lower than WAC, varying by provider.
Future Price Projections (2023-2027)
- Short-term (next 1-2 years): Prices are expected to stabilize around USD 15-25 per vial due to ongoing generic competition.
- Medium-term (3-5 years): Slight downward pressure anticipated owing to increased manufacturing efficiencies and potential biosimilar entry. Prices could decline to USD 12-20 per vial.
- Potential upward pressures: Supply chain disruptions, regulatory changes, or shortages could temporarily increase prices.
Pricing Influences
- Regulatory environment: FDA approvals for biosimilars or new formulations can alter price dynamics.
- Manufacturing costs: Patent expirations reduce exclusivity, lowering prices.
- Market penetration: Entry of low-cost generics increases competition, putting downward pressure on prices.
Regulatory Status and Implications
- The drug is marked as approved by the FDA under NDA approval date of May 2019.
- No current generic exclusivity blocks the market; multiple generics are available.
- Any new formulation approval or label updates could influence pricing.
Investment and Business Considerations
- Entry of biosimilars or new delivery methods (e.g., sustained-release formulations) could disrupt pricing.
- Companies emphasizing manufacturing cost reduction could gain competitive advantage.
- Contracting and procurement strategies significantly influence net pricing for healthcare providers.
Summary Table: Price Projections Summary
| Year |
Expected Price Range (USD per vial) |
Major Influences |
| 2023 |
15-25 |
Competitive generics, stable regulatory environment |
| 2024 |
15-23 |
Market saturation, potential supply chain issues |
| 2025 |
12-20 |
Increased biosimilar competition, efficiency gains |
| 2026 |
12-20 |
Market consolidations, policy influences |
| 2027 |
12-20 |
Market maturity, steady patent expiry effects |
Key Takeaways
- The current market for NDC 63304-0924 (amiodarone infusion) is mature, with prices declining due to generic competition.
- Prices are expected to stabilize in the USD 12-20 range over the next five years absent significant market disruptions.
- Market growth is driven by increasing cardiac arrhythmia prevalence, but constrained by side effect risks and therapy alternatives.
- Future pricing will depend on regulatory decisions, supply chain stability, and new competitor entries.
- Investment strategies should focus on manufacturing efficiencies and potential biosimilar developments.
FAQs
Q1: How does the entry of biosimilars influence amiodarone prices?
A: Biosimilar entry generally reduces prices through increased competition, especially if they demonstrate similar efficacy and safety profiles.
Q2: Are there significant regional price differences?
A: Yes. The US market tends to have higher prices due to brand dominance and reimbursement policies, while generic prices are lower elsewhere.
Q3: What are the regulatory risks impacting pricing?
A: Regulatory delays or restrictions on generic approvals, or new safety warnings, can influence market availability and pricing.
Q4: How does supply chain stability affect prices?
A: Disruptions can lead to shortages, temporarily increasing prices, especially if production capacities are limited.
Q5: What alternative therapies could impact the market?
A: Catheter ablation, advanced implantable devices, and novel antiarrhythmic agents could limit the long-term growth and influence pricing strategies.
References
- MarketWatch. (2023). Antiarrhythmic drug market data and forecasts.
- FDA. (2019). NDA approval details for amiodarone hydrochloride.
- IQVIA. (2022). Healthcare market analysis and drug pricing trends.
- Pharma Intelligence. (2022). Generic drug market competition analysis.
- World Health Organization. (2022). Cardiac arrhythmias prevalence and management data.
