Last updated: March 2, 2026
What is NDC 00065-0345?
NDC 00065-0345 is the code assigned to a specific pharmaceutical product. It corresponds to Amphotericin B Liposomal, a formulation used primarily for systemic fungal infections and cryptococcal meningitis, especially in immunocompromised patients.
Market Overview
Product Classification
- Drug Name: Amphotericin B Liposomal
- Therapeutic Area: Antifungal agent
- Formulation: Liposomal encapsulation improves toxicity profile over conventional Amphotericin B
- Route of Administration: Intravenous
Current Market Size
The global antifungal market was valued at approximately $4.2 billion in 2022, with the liposomal Amphotericin B segment representing an estimated 30-35%. The growth rate (CAGR) projected at around 4.8% from 2023 to 2028.
Leading Competitors
- Gilead Sciences (brand: AmBisome)
- Menarini (brand: AmBisome, licensed from Gilead)
- Others: generic manufacturers escalating in emerging markets
Prescription Trends
- Increased use in transplant and AIDS-related cryptococcal infections
- Growing adoption driven by better safety profile over conventional Amphotericin B
- COVID-19 pandemic and associated immunosuppression have temporarily intensified demand
Regulatory Status
- Approved by the FDA as of 1997
- Marketed in Europe, Asia, and Latin America
- Some markets have approved biosimilars and generics, increasing competition
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 50 mg vial |
Notes |
| 2018 |
$500 |
Price stabilized amid patent protections |
| 2020 |
$530 |
Slight increase, market stability |
| 2022 |
$550 |
Market observed mild inflation |
Current Pricing Dynamics
- Gilead's AmBisome: Approx. $550 per 50 mg vial (USD)
- Biosimilar options in Europe: Approx. $450–$500
- Generic entries in Asia: <$400 in select markets, though quality and regulatory variances exist
Price Drivers
- Manufacturing complexity of liposomal formulation
- Patent protections expiring or expired in some regions
- Competition from biosimilars and generics
- Supply chain factors: raw material costs, manufacturing capacity
- Regulatory environment affecting pricing policies
Future Price Projections (2023–2028)
| Year |
Expected Price Range per 50 mg vial |
Market Influences |
| 2023 |
$550–$585 |
Slight inflation, patent expirations, increased biosimilar market entry |
| 2024 |
$560–$600 |
Growing biosimilar competition, manufacturing efficiencies |
| 2025 |
$565–$610 |
Price stabilization due to increased market access, biosimilar proliferation |
| 2026 |
$570–$620 |
Potential price erosion in competitive markets, patent challenges |
| 2027 |
$580–$630 |
Industry consolidation, new formulations possibly affecting pricing |
| 2028 |
$590–$650 |
Price stabilization, adjusted for inflation and supply chain trends |
Key factors influencing projection accuracy
- Patent expiration dates vary; in the US, Gilead's patent expired in 2017, opening biosimilar pathways.
- New formulations or delivery methods could impact prices.
- Emerging markets may see reduced prices with biosimilar penetration.
- Inflation rates, raw material costs, and manufacturing innovations will shape future costs.
Regulatory and Market Entry Barriers
- Strict quality standards for biosimilars slowing market entry.
- Patent litigation delaying generic penetration in some regions.
- Supply chain complexities influencing cost structures.
- Pricing regulations in heavily regulated markets such as the US and EU.
Key Takeaways
- The antifungal market, particularly for liposomal Amphotericin B, has seen modest growth due to its safety advantage.
- Price stability has persisted over recent years, but patent expirations and biosimilar competition are expected to pressure prices downward over the next five years.
- The current average market price in the US is approximately $550 per 50 mg vial, with regional variations dominated by biosimilar and generic availability.
- Price projections indicate gradual increases driven mainly by inflation and supply chain factors, but potential market entry of biosimilars could offset this trend.
FAQs
1. When did patent protection for Gilead’s AmBisome expire?
Patent protections in the US expired in 2017, opening pathways for biosimilar development.
2. What factors influence Amphotericin B Liposomal prices?
Manufacturing complexity, patent status, biosimilar competition, regulation, and raw material costs.
3. How does biosimilar competition impact pricing?
Increased biosimilar availability typically reduces prices by 10-20% over established brand prices.
4. Are biosimilars approved globally for Amphotericin B Liposomal?
Biosimilar approvals vary; in Europe, several have been approved, whereas in the US, biosimilars are still under review or pending.
5. What future market trends are expected for Amphotericin B Liposomal?
Growing adoption in fungal infection treatment, further biosimilar market entry, and potential price erosion in competitive markets.
References
- MarketWatch. (2023). "Antifungal Drugs Market Size, Share & Trends Analysis." [Online] Available at: https://www.marketwatch.com/
- Gilead Sciences. (2022). "Product Information for AmBisome." [Online] Available at: https://www.gilead.com/
- IQVIA. (2022). "Global Pharmaceutical Market Data Report." [Online] Available at: https://www.iqvia.com/
- U.S. Food and Drug Administration. (2022). "Biosimilar Development and Approval." [Online] Available at: https://www.fda.gov/
- European Medicines Agency. (2022). "Biosimilars Guideline." [Online] Available at: https://www.ema.europa.eu/
