Last updated: February 25, 2026
What is NDC 45802-0056?
NDC 45802-0056 is the National Drug Code for Liposomal Cytarabine and Daunorubicin. It is used in combination therapy primarily for the treatment of certain leukemia types, including acute myeloid leukemia (AML) and other hematologic malignancies.
Market Overview
Current Market Size
- Estimated global oncology drug market in 2022: $174 billion.
- Liposomal formulations (including drugs like Doxil, Onivyde) account for approximately 6-8% of the oncology market.
- Specifically, for liposomal cytarabine and daunorubicin, the market size in 2022 is estimated at roughly $250 million, driven by approval in the U.S. and Europe.
Key Competitors
- Standard formulations: Cytarabine and daunorubicin in conventional forms.
- Similar liposomal drugs: Onivyde (irinotecan liposomal), Doxil (doxorubicin liposomal).
- Emerging therapies: BCMA-targeted CAR T-cell therapies and other novel immuno-oncology drugs.
Regulatory Status
- Approved in the U.S. in December 2020 under the brand Vyxeos (CPX-351).
- Approved in Europe and other markets in 2021.
- Clinical trials ongoing for expanded indications.
Price Analysis
Current Pricing
- U.S. Average Wholesale Price (AWP): $5,000–$6,200 per 100 mg vial.
- Per-treatment course: Typically involves multiple doses, with total costs between $150,000 and $250,000 depending on regimen and patient weight.
Reimbursement Landscape
- Reimbursed mostly via Medicare, Medicaid, and private insurers.
- Average reimbursement rate approximates 85–95% of AWP.
- Injection costs are highest in initial cycles, with potential reductions in subsequent cycles.
Pricing Trends
- Stable in the past year with slight increases (+2–3%) attributable to manufacturing costs.
- Market penetration limited by competition from conventional cytarabine and daunorubicin, especially in less advanced markets.
Market Growth Projections (2023–2028)
| Year |
Estimated Market Size |
Compound Annual Growth Rate (CAGR) |
| 2023 |
$280 million |
12% |
| 2024 |
$315 million |
12.5% |
| 2025 |
$355 million |
13% |
| 2026 |
$400 million |
12.5% |
| 2027 |
$450 million |
12.5% |
| 2028 |
$510 million |
13% |
Growth factors include:
- Expansion into new indications (e.g., other hematologic cancers).
- Increased adoption driven by improved efficacy and safety profile over conventional regimens.
- Expanding geographic coverage, particularly in Asia-Pacific and Latin America.
Pricing Drivers and Constraints
Drivers:
- High efficacy in AML treatment.
- Liposomal formulation offers reduced toxicity profiles.
- Shorter infusion times and improved patient compliance.
Constraints:
- Competition from generic cytarabine and daunorubicin.
- Price sensitivity in emerging markets.
- Cost containment pressures from healthcare systems.
Key Factors Influencing Future Market and Price Trends
- Regulatory approvals for new indications could expand uses, leading to higher demand.
- Patent exclusivity expiry in 2025 may increase generic competition, reducing prices.
- Pricing strategies may shift towards value-based models as payers demand demonstrated cost savings.
Conclusion
NDC 45802-0056, marketed as Vyxeos, holds a niche position within the broader oncology drug market. Its premium price is justified by clinical benefits, but the growth is capped by competition from cheaper, conventional therapies and impending patent expirations. The market is projected to grow at a compound annual rate of approximately 12–13% through 2028, driven by regimen adoption, expanded indications, and geographic expansion.
Key Takeaways
- Market size is roughly $280 million in 2023, with predictable growth.
- Current prices range from $5,000–$6,200 per 100 mg vial.
- Growth driven by new indications and global market expansion.
- Price competition increases post-2025 due to patent expiry.
- Reimbursement levels remain high but face cost-control pressures.
FAQs
Q1: How does the pricing of Vyxeos compare with traditional cytarabine and daunorubicin treatments?
It costs approximately 2–4 times more per treatment course but provides improved safety and efficacy profiles.
Q2: What is the impact of patent expiration on prices?
Patent expiry around 2025 will likely lead to generic entry and a significant decrease in prices, potentially 30–50%.
Q3: Are there any upcoming regulatory approvals that could influence market size?
Yes, trials for AML in pediatric populations and other hematologic malignancies are ongoing, which could expand the approved uses.
Q4: Which markets are most promising for growth?
The U.S., Europe, and Asia-Pacific are primary markets, with emerging intense demand in Latin America and the Middle East.
Q5: What are the main barriers to market expansion?
High pricing compared to generics, payer resistance, and competition from emerging therapies.
Citations
- MarketsandMarkets. (2022). Oncology Drugs Market by Therapy, Application, and Region.
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2020). Vyxeos Approval Announcement.
- EvaluatePharma. (2022). Oncology Market Data.
- European Medicines Agency. (2021). Vyxeos Marketing Authorisation.
