Last updated: February 26, 2026
What is NDC 78206-0112?
NDC 78206-0112 corresponds to Liposomal Amphotericin B (AmBisome), produced by Gilead Sciences. It is an antifungal agent used to treat invasive fungal infections, including aspergillosis, cryptococcosis, candidiasis, and visceral leishmaniasis.
Market Size and Demand Dynamics
Current Utilization
- Estimated global sales: approximately $600 million in 2022.
- Primary markets: United States, European Union, Japan.
- Usage driven by transplant centers, oncology units, and infectious disease specialists.
Key Market Drivers
- Increasing prevalence of invasive fungal infections among immunocompromised populations.
- Rising transplant and oncology procedures expanding patient base.
- Limited alternatives due to resistance development and drug-specific efficacy profiles.
Competitive Landscape
| Product |
Manufacturer |
Approval Year |
Formulation |
Market Share (2022) |
| AmBisome (Liposomal Amphotericin B) |
Gilead Sciences |
1990 |
Liposomal |
80% |
| Amphotericin B deoxycholate |
Various |
1955 |
Conventional |
15% |
| Other Liposomal formulations |
Various |
2000s |
Liposomal |
5% |
Gilead’s AmBisome dominates due to superior safety profile, especially reduced nephrotoxicity, compared to conventional formulations.
Price Structure and Cost Analysis
Current Listing Prices (United States)
- Per vial (50 mg): $1,200 – $1,500.
- Typical therapy course: 200-400 mg/day for 14-21 days.
Sample cost estimate:
| Dose |
Cost per Course |
| 200 mg/day x 14 days |
~$33,600 - $42,000 |
| 400 mg/day x 14 days |
~$67,200 - $84,000 |
Insurance and Reimbursement
- Reimbursement rates generally align with Medicare/Medicaid standards.
- High therapy costs influence hospital formularies and budget planning.
Pricing Trends
- Slight decrease (~2-3%) observed in volume-based discounts since 2018.
- New formulations or biosimilars could pressure prices further in upcoming years.
Market Growth and Future Price Projections
Expected Market Growth
- CAGR of approximately 4-5% from 2023 to 2028.
- Growth driven by expanded indications like leishmaniasis and novel combinations.
Price Projections (2023–2028)
| Year |
Estimated Price Range (per vial) |
Key Drivers |
| 2023 |
$1,200 – $1,500 |
Stable demand, limited competition |
| 2024 |
$1,150 – $1,450 |
Price negotiations, potential biosimilar entry |
| 2025 |
$1,100 – $1,400 |
Increased biosimilar market, price pressures |
| 2026 |
$1,050 – $1,350 |
Market saturation, economies of scale |
| 2027 |
$1,000 – $1,300 |
Rising biosimilar competitiveness |
| 2028 |
$950 – $1,250 |
Cost reductions, generic proliferation possible |
Impact of Biosimilars and Generics
- Biosimilars are emerging, with tentative approval in Europe.
- U.S. FDA pathways for biosimilars show approval timelines of 3–5 years.
- Introduction could reduce prices by 20-30% in the long term.
Regulatory and Policy Influences
- Orphan drug designation reduces development costs and extends exclusivity.
- Pricing regulations in Europe and negotiations by government payers influence list prices.
- Price caps or negotiations in Medicare/Medicaid could affect U.S. pricing strategies.
Key Considerations for Stakeholders
- Manufacturers: supply chain stability and patent management are critical.
- Investors: valuation hinges on biosimilar pipeline success and market penetration.
- Healthcare providers: balancing cost, efficacy, and safety considerations.
Key Takeaways
- The global market for liposomal amphotericin B is expected to grow at a slow but steady rate.
- Prices are currently high but face pressure from biosimilar development.
- The drug’s dominance remains due to its efficacy and safety profile.
- Future price reductions are likely as biosimilars gain approval and market share.
- Regulatory and policy environments will shape the pricing landscape, especially in the U.S. and Europe.
FAQs
1. What is the primary indication for NDC 78206-0112?
Invasive fungal infections in immunocompromised patients.
2. How does the price of AmBisome compare to conventional amphotericin B?
Liposomal formulations cost approximately 8-10 times more per dose, reflecting reduced toxicity and better tolerability.
3. What are the prospects for biosimilar competition?
Biosimilars are in development, with potential approval in the next 2-4 years; they are expected to reduce prices by 20-30%.
4. How might policy changes impact prices?
Price negotiations, especially in the U.S. and Europe, could lower list prices; drug reimbursement policies may also influence sales.
5. What factors could limit further price declines?
Brand loyalty, patent protections, and limited biosimilar supply initially restrict price decreases.
References
[1] Gilead Sciences. (2022). AmBisome product profile. Retrieved from https://www.gilead.com
[2] IQVIA. (2022). US Pharmaceutical Market Data.
[3] FDA. (2022). Biosimilar Development and Approval. Retrieved from https://www.fda.gov
[4] EvaluatePharma. (2022). 2022 World Revenue Forecasts.
