Last updated: March 13, 2026
What is NDC 00536-1217?
NDC 00536-1217 refers to Amphotericin B Liposomal (brand: AmBisome). It is an antifungal medication used primarily for invasive fungal infections, including cryptococcal meningitis, visceral leishmaniasis, and Aspergillus infections. It is administered intravenously and has a high price point due to manufacturing complexity.
Market Overview
Market Size and Demand Drivers
- Global growth of invasive fungal infections: Increasing immunocompromised populations (HIV/AIDS, transplant recipients, leukemia) drive demand.
- Treatments approved in multiple regions: U.S., Europe, Asia.
- Availability of generic formulations: Limited, with primary patents held until 2030.
- Annual global sales estimates: Approximate $250-$350 million (2022), with upward potential due to rising infection rates [1].
Competitive Landscape
| Product Name |
Manufacturer |
Formulation |
Patent Status |
Market Share (Est.) |
Remarks |
| AmBisome |
Gilead Sciences |
Liposomal Amphotericin B |
Patent until 2030 |
~80% |
Most prescribed liposomal formulation |
| Amphotec |
Teva |
Amphotericin B Cholesterol Complex |
Off-patent |
15% |
Lower cost alternative |
| Fungizone |
Bristol Myers Squibb |
Amphotericin B deoxycholate |
Off-patent |
5% |
Older, less favored formulation |
Regulatory and Pricing Trends
- U.S.: AmBisome priced around $3,000–$4,000 per vial; institutional prices vary.
- Europe: Slightly lower pricing but similar high-cost structure.
- Emerging markets: Cost-effective, generic formulations dominate.
- Market pressures: Biosimilar entries expected post-2030 patent expiration could challenge market share.
Price Projections (2023–2030)
| Year |
Estimated Average Price per Vial |
Key Drivers |
Notes |
| 2023 |
$3,200 |
Stable market demand; limited generics |
Slight discounts in bulk purchasing |
| 2024 |
$3,150 |
Competitive pressure rising |
Patent exclusivity continues |
| 2025 |
$3,000 |
Patent holding firm, some biosimilars emerging |
Entry of biosimilars may begin late 2025 |
| 2026 |
$2,850 |
Increased biosimilar activity |
Price discounts intensify |
| 2027 |
$2,700 |
Market saturation for biosimilars |
Competition drives down prices |
| 2028 |
$2,500 |
Intensified biosimilar competition |
Price reductions driven by payers |
| 2029 |
$2,300 |
Growing generics market |
Price stabilization, patent expiry approaches |
| 2030 |
$2,200 |
Patent expiry, biosimilars fully introduced |
Expected significant generic penetration |
Note: Pricing assumes continued market stability, no extraordinary supply disruptions, and ongoing demand. Actual prices may vary by region and contract.
Factors Influencing Future Market and Prices
- Patent expiration in 2030: Likely to open market for biosimilar versions, leading to potential price drops of 30-50%.
- Regulatory changes: Accelerated approval pathways for generics/biosimilars, especially in Asia, could alter price dynamics.
- Treatment protocols: New formulations or combination therapies could impact demand.
- Pricing policies: Cost containment efforts in healthcare systems may exert downward pressure.
Conclusion
NDC 00536-1217 (AmBisome) maintains a dominant position in invasive fungal infection treatment, supported by its specialized liposomal formulation. Market revenues are projected to remain stable through 2025, with prices gradually declining as biosimilar options emerge post-2030. Manufacturers and investors should watch patent expirations, biosimilar developments, and regional pricing policies for strategic planning.
Key Takeaways
- The current market for AmBisome is approximately $250-$350 million annually.
- Prices per vial are around $3,000–$4,000 in major markets, with potential decline after 2030.
- Patent expiry in 2030 opens avenues for biosimilar competition, likely reducing prices.
- Demand remains driven by increasing immunocompromised patient populations.
- Regulatory and policy changes could accelerate price adjustments.
FAQs
1. When will biosimilars for Amphotericin B Liposomal become available?
Biosimilars are anticipated after 2030, following patent expiration, depending on regulatory approvals.
2. How much could prices drop post-2030?
Biosimilar competition could reduce prices by 30-50%, potentially bringing vial costs below $1,500.
3. Are there alternatives to AmBisome for invasive fungal infections?
Yes. Amphotericin B deoxycholate (older) and amphotericin B cholesterol complex (less common) are less expensive options but have higher toxicity.
4. How does regional regulation impact prices?
Region-specific policies, such as price caps in Europe and emerging markets, influence pricing strategies and profit margins.
5. What regulatory hurdles exist for biosimilar approval?
Biosimilar approval requires demonstrating comparable efficacy, safety, and manufacturing quality, which can be complex for complex molecules like liposomal formulations.
References
[1] MarketsandMarkets. (2022). Global antifungal drugs market. https://www.marketsandmarkets.com
[2] FDA. (2021). Approved drugs database. https://www.fda.gov
[3] IQVIA. (2022). Pharmaceutical Price Reports. https://www.iqvia.com
