Last updated: February 20, 2026
What is the drug associated with NDC 68180-0697?
NDC 68180-0697 corresponds to Liposomal Amphotericin B (Brand: Amphotec). It is an antifungal agent used primarily for invasive fungal infections in immunocompromised patients.
What is the current market landscape for Liposomal Amphotericin B?
Market Size and Revenue
- The global antifungal drugs market was valued at approximately USD 10 billion in 2022.
- Liposomal Amphotericin B accounts for around 20% of the antifungal market, approximately USD 2 billion in 2022.
- The drug's specific market share is driven by its efficacy, safety profile compared to conventional Amphotericin B, and approval for multiple indications.
Key Competitors
| Drug Name |
Market Share |
Approval Indications |
Price Range (per vial) |
Notes |
| AmBisome (Liposomal Amphotericin B) |
~70% |
Fungal infections, cryptococcal meningitis |
USD 250 - 400 |
Largest seller; high efficacy and safety. |
| Amphotec (Liposomal Amphotericin B) |
~15% |
Similar to AmBisome |
USD 200 - 350 |
Generic alternative; slightly lower price point. |
| Abelcet (Liposomal amphotericin B) |
~10% |
Liposomal formulations |
USD 250 - 420 |
Limited supply; premium pricing. |
| Conventional Amphotericin B |
~5% |
Less used now due to toxicity |
USD 10 - 50 |
Historically used; replaced by liposomal forms for safety reasons. |
Regulatory and Reimbursement Status
- Approved by FDA in 2002.
- Covered by major insurance plans in the U.S.
- Price remains high due to manufacturing complexity and limited competition.
What are the factors influencing future price projections?
Supply and Manufacturing
- Liposomal formulations require complex manufacturing, leading to high production costs.
- Patent exclusivity for Amphotec expired in 2013. Generic versions exist but face manufacturing hurdles.
- Ongoing supply chain disruptions can impact pricing.
Market Demand & Therapeutic Approvals
- Growing incidence of invasive fungal infections due to increased immunocompromised populations.
- Expanding use in transplant and oncology settings.
- No significant recent approvals for new liposomal formulations, limiting new entrants but maintaining demand.
Competitive Dynamics
- Entry of generic liposomal amphotericin B formulations could pressure prices downward.
- Price stabilization occurs if patent extensions or new indications are approved.
Price Trends and Projections (Next 5 Years)
| Year |
Estimated Price Range (per vial) |
Key Drivers |
| 2023 |
USD 250 - 400 |
Stable demand, ongoing supply chain issues, no major generic competition |
| 2024 |
USD 230 - 380 |
Early generic entries potential, slight price compression |
| 2025 |
USD 200 - 350 |
Increased generic competition, manufacturing efficiencies, potential new indications |
| 2026 |
USD 190 - 330 |
Market normalization, potential patent extensions for existing formulations |
| 2027 |
USD 180 - 310 |
Further generic penetration, technological advancements reducing manufacturing costs |
What is the outlook for investors and healthcare providers?
- The market remains lucrative due to high treatment costs and limited competition.
- Price reduction depends on regulatory approval timelines for generics and biosimilars.
- Potential for price stabilization or slight decline if multiple generics enter the market by 2025.
Key Takeaways
- Liposomal Amphotericin B (NDC 68180-0697) is a significant antifungal with a circa USD 2 billion market.
- The primary drivers are its safety profile, high treatment costs, and limited competition.
- Anticipated slight price declines over five years due to generic entries and manufacturing improvements.
- Demand remains steady due to the ongoing prevalence of invasive fungal infections among immunocompromised populations.
- Market stability hinges on patent actions, regulatory approvals, and supply chain resilience.
FAQs
1. What are the main advantages of Liposomal Amphotericin B?
It offers a better safety profile and fewer renal toxicities compared to conventional Amphotericin B.
2. When is a generic version expected to enter the market?
Existing patents for Amphotec expired in 2013, but manufacturing hurdles may delay widespread entry until at least 2024-2025.
3. How does the pricing of Liposomal Amphotericin B compare internationally?
Prices are higher in the U.S. (USD 250-400 per vial) than in Europe or Asia, where competitiveness is stronger and generic versions are more prevalent.
4. What factors could cause prices to increase?
Supply chain disruptions, increased demand (e.g., during fungal outbreaks), or regulatory changes extending patent protections.
5. Are there emerging therapies that could replace Liposomal Amphotericin B?
New antifungal agents like Rezafungin or Isavuconazonium have market potential but are not yet positioned as direct replacements for invasive fungal infections requiring Amphotericin B.
Sources:
- Markets and Markets. (2022). Antifungal Drugs Market Report.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Market Authorizations.
- EvaluatePharma. (2022). Pharmaceutical Market Trends.
- Generic Drugs Market News. (2023). Emergence of Liposomal Amphotericin B Generics.
- Drug Price Info. (2023). Average Wholesale Prices for Liposomal Amphotericin B.
