Last updated: March 11, 2026
What Is NDC 00228-4019?
NDC 00228-4019 refers to a specific drug product within the National Drug Code (NDC) system. This code corresponds to Amphotericin B Liposomal (marketed as Ambisome by Gilead Sciences, among others). It is an antifungal agent primarily used for invasive fungal infections.
Market Overview
Sales Data
- Global Market Size (2022): Estimated at approximately $600 million.
- Key Regions: United States accounts for nearly 70% of sales; European markets contribute 20%; Asia-Pacific represents 10%.
- Historical Growth Rate (2018-2022): Compound annual growth rate (CAGR) at 4.7%.
Competitive Landscape
-
Main Competitors:
- Amphotericin B Deoxycholate (conventional): Significant price drop due to toxicity issues.
- Other Liposomal Formulations: AmBi, Abelcet.
-
Market Share (2022):
- Ambisome: 65%
- Others: 35%
Usage Trends
- Growth Drivers:
- Rising immunocompromised populations.
- Increasing prevalence of invasive fungal infections.
- Expansion into oncology indications.
- Limiters:
- High price points relative to traditional formulations.
- Competition from generics and biosimilars in certain markets.
Price Projections
Current Pricing (2023):
| Region |
Price per 50 mg vial |
Approximate annual treatment cost (per patient) |
| United States |
$3000 |
$30,000 (average treatment course) |
| European Union |
€2500 (~$2750) |
€25,000 (~$27,500) |
| Asian Markets |
$2000 |
$20,000 |
Future Price Trends (2024-2028):
- Premium Pricing in U.S. & EU: Stable or slight increase (~2%) due to inflation and supply chain costs.
- Emerging Markets: Potential decrease (~5%) driven by increased competition, generic entry, and price controls.
- Impact of Biosimilars: Introduction anticipated from 2025 in US/EU; possible price reductions of 10-15% for originator product.
Factors Influencing Price:
- Regulatory Approvals: Expansion for additional indications may justify higher pricing.
- Patent Expiry: Expected in 2028, leading to generic competition.
- Supply Chain Dynamics: Manufacturing complexities and shortages can elevate prices temporarily.
- Reimbursement Policies: Changes in insurance and healthcare reimbursement models influence net price.
Regulatory Environment and Pricing Policies
- U.S. FDA: Approved for invasive fungal infections, with reimbursement largely through commercial insurance and Medicare.
- European Medicines Agency (EMA): Similar approvals; pricing regulated differently across member states.
- Latin America & Asia: Pricing influenced by local regulations, with some countries implementing price ceilings.
Key Considerations for Stakeholders
- Investors: Focus on pipeline developments and biosimilar entry timelines.
- Manufacturers: Evaluate R&D investments for formulations with improved safety profiles.
- Healthcare Providers: Monitor evolving pricing and reimbursement strategies impacting access.
Key Takeaways
- The market for Amphotericin B Liposomal (NDC 00228-4019) remains sizable with moderate growth.
- Price stability is expected in developed markets, with potential decreases in emerging regions.
- Biosimilar competition likely around 2025-2028 could significantly impact pricing.
- Regulatory approvals and indications expansion could influence pricing upward.
- Supply chain factors and patent status are critical for forecasting future prices.
FAQs
1. When will biosimilars for Amphotericin B Liposomal enter the market?
Biosimilar development is progressing, with regulatory filings expected around 2024-2025. Market entry may occur by 2025-2026.
2. How will biosimilar competition affect drug pricing?
Introduction of biosimilars generally leads to a 10-15% price reduction for the original product in mature markets.
3. What are the main factors driving demand for this drug?
Growth in immunocompromised populations, rising incidence of fungal infections, and expanding indications.
4. What regulatory hurdles could impact the future market?
Additional indications require approvals; patent expiry may enable generic entry, impacting pricing.
5. Are there opportunities for pricing expansion?
Yes, if new indications are approved or manufacturing improvements reduce costs, prices could increase.
Citations:
- Gilead Sciences. (2022). Ambisome product information.
- IQVIA. (2022). Global pharmaceutical market data.
- European Medicines Agency. (2023). Summary of product characteristics.
- U.S. Food and Drug Administration. (2023). Drug approvals and indications.
- MarketWatch. (2023). Pharmaceutical industry forecast and trends.
