Last updated: February 23, 2026
What Is NDC 69292-0584?
NDC 69292-0584 identifies a specific drug product. Based on available data, this code corresponds to Fusilev (levoleucovorin calcium) injection. It is a chemoprotective agent used as an adjunct to chemotherapy, particularly in colorectal cancer to reduce toxicity associated with high-dose methotrexate.
Market Size and Key Drivers
Market Overview
- Indications: Primarily used in oncology for chemotherapy support.
- Prevalence: Colorectal cancer ranks as the third most common cancer worldwide, with an estimated 1.9 million new cases in 2020 (WHO).
- Treatment Trends: Increased adoption of aggressive chemotherapy regimens enhances demand.
Competitive Landscape
- Existing Alternatives: Leucovorin (folinic acid) and leucovorin calcium.
- Market Players: Multiple generic manufacturers; no current branded dominance for levoleucovorin.
- Regulations: FDA approval granted for Fusilev in 2009, expanding its adoption in chemotherapy protocols.
Revenue Estimates
- Global Oncology Supportive Care Market (2022): Valued at approximately USD 10 billion.
- Levoleucovorin's Share: Difficult to specify precisely due to generic status, but estimates place annual sales between USD 100 million and USD 250 million (IQVIA, 2022).
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 180–200 per vial (20 mg/40 mL), varies by distributor.
- Reimbursement Rates: Varies across regions; U.S. Medicare Part B reimburses at approximately 106–112% of AWP.
Price Trends
- Historical Trends: Prices for levoleucovorin have remained relatively stable since FDA approval, with minor fluctuations due to manufacturing efficiencies.
- Market Entry of Generics: Likely to exert downward pressure, reducing prices by 10%–20% over the next 3–5 years.
Future Price Projections (Next 5 Years)
| Year |
Expected Price Range per Vial (USD) |
Rationale |
| 2023 |
180–200 |
Current market stability |
| 2024–2025 |
160–180 |
Entry of additional generic manufacturers |
| 2026–2027 |
140–160 |
Increased generic competition and pricing pressures |
Factors Influencing Future Prices
- Generic Competition: Increased manufacturing capacity lowers prices.
- Regulatory Changes: New approvals can expand indications, potentially stabilizing prices.
- Reimbursement Policies: Changes in insurer policies may impact net prices.
- Supply Chain Dynamics: Manufacturing costs and raw material prices influence pricing.
Market Trends and Opportunities
- Off-Label Uses: Potential expansion into other supportive oncology roles.
- Biotech Innovation: Biologics or biosimilars could disrupt the supportive care segment.
- Regional Variations: Prices are higher in the U.S., with emerging markets offering lower price points.
Risks and Barriers
- Pricing Pressure: Intense competition among generics.
- Regulatory Risks: FDA or international agency changes might impact approval status or prescribing.
- Market Saturation: Large producer presence limits profit margins.
Key Takeaways
- NDC 69292-0584 (Fusilev) operates in a mature, competitive market with stable demand linked to chemotherapy supportive care.
- The current average wholesale price is approximately USD 180–200 per vial, with state-sponsored reimbursement around 106–112%.
- Price declines are expected due to increased generic competition, estimated at 10%–20% over several years.
- Revenue for the drug remains primarily driven by colorectal cancer treatment, with potential growth through expanded indications.
- Significant upside exists in regional markets with lower adoption rates but declining prices similar to U.S. patterns.
FAQs
1. Will generic competition drastically reduce Fusilev's price in the next year?
Price reductions typically become evident within 1–2 years following the entry of additional generic manufacturers, causing a 10%–20% reduction.
2. Are there new formulations or indications that could increase demand?
Current approvals focus on chemotherapy support. Expansion into other supportive treatments or new formulations is unlikely in the short term.
3. How does regional pricing vary compared to the U.S.?
Emerging markets often see prices 50%–70% lower; regulatory and reimbursement differences play roles.
4. What factors could stabilize or increase price levels?
Introduction of new indications, manufacturing quality improvements, or supply chain shortages could stabilize or boost prices.
5. Does patent exclusivity influence current market prices?
Levoleucovorin is a generic shortly after patent expiry, which supports lower prices due to competition.
References
[1] World Health Organization. (2020). Cancer Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/cancer
[2] IQVIA. (2022). Global Oncology Market Report.
[3] Food and Drug Administration. (2009). Fusilev Approval Announcement.
[4] Medicare.gov. (2023). Part B Reimbursement Rates.
