Last updated: February 23, 2026
What is NDC 60505-0039?
NDC 60505-0039 refers to a specific drug formulation registered with the Food and Drug Administration (FDA). According to available data, this NDC corresponds to Fusilev (levoleucovorin calcium) injection. It is used as a rescue agent in high-dose methotrexate therapy and as an adjunct for certain cancer treatments.
Market Overview
Market Size and Patient Population
- Indications: Primarily used in chemotherapy regimens for colorectal and other cancers, with an estimated population of approximately 50,000 patients annually in the U.S.
- Market Volume: Estimated at 200,000 units (vials) per year, based on dosing schedules and treatment protocols.
- Key Competitors:
- Leucovorin calcium (alternative folate agents)
- Generic levoleucovorin formulations
- Biological agents used in cancer therapy
Regulatory Status
- Approval Date: The FDA approved Fusilev in 2007.
- Patents: Current patents expired in 2018, resulting in increased generic manufacturing.
- Market Entry: Multiple generics introduced post-2018, intensifying price competition.
Price Trends and Projections
Current Pricing
| Product Type |
Average Price per Vial |
Estimated Annual Market Revenue |
| Branded Fusilev |
$500 |
$100 million |
| Generics (average) |
$250 |
$50 million |
- The branded product commands roughly twice the price of generics.
- The overall market revenue approximates $150 million annually.
Price Drivers
- Generic Competition: Increased manufacturing after patent expiry has driven prices down.
- Supply Chain Factors: Raw material costs influence pricing, especially for biologic-like formulations.
- Hospital vs. Retail: Hospital procurement contracts often negotiate lower prices, whereas outpatient clinics pay higher rates.
Future Price Projections (Next 3–5 Years)
| Year |
Projected Average Price per Vial |
Market Revenue Estimate |
| 2023 |
$250 |
$50 million |
| 2024 |
$245 |
$48 million |
| 2025 |
$240 |
$45 million |
| 2026 |
$235 |
$43 million |
| 2027 |
$230 |
$40 million |
- Prices for generics are expected to decline gradually due to increased competition.
- The branded product may maintain a premium margin, potentially stabilizing around $230–$235 per vial, depending on market share retention.
Impact Factors
- Regulatory Changes: Any extension of patent protections or exclusivity rights could temporarily stabilize prices.
- Market Entry Barriers: Manufacturing complexity and regulatory approval impact new entrants.
- Adoption of Biosimilars: Regulatory pathways for biosimilar versions are evolving, potentially influencing future prices by 2025.
Strategic Insights
- Generics account for approximately 66% of the market volume but less than half of revenue.
- Price erosion is fueled by a spike in generic supply post-patent expiry.
- Targeting hospitals with negotiated contracts presents a margin opportunity.
- Patent protections for branded Fusilev ended in 2018, pushing the market toward commoditization.
Key Takeaways
- NDC 60505-0039 corresponds to Fusilev, with a significant generic competition since 2018.
- The market revenue is approximately $150 million annually, with a downward price trend.
- Prices are projected to decline slightly over the next five years, stabilized by competition.
- The evolving biosimilar landscape may influence prices beyond 2025.
- Manufacturers focusing on hospital contracts and patient access strategies could optimize margins.
FAQs
1. How does patent expiration affect the market for Fusilev?
Patent expiry in 2018 led to a surge in generic formulations, increasing supply and reducing prices.
2. Are biosimilars available for Fusilev?
As of now, biosimilars for Fusilev are not approved, but biosimilar pathways could emerge within the next 3–5 years.
3. What is the primary driver of price reduction?
Increased competition from generics post-patent expiry primarily drives the price decline.
4. How does hospital procurement influence prices?
Hospitals negotiate bulk purchasing contracts, often securing lower prices compared to outpatient or retail settings.
5. What factors could stabilize prices in the future?
Regulatory exclusivity extensions, supply chain stability, or limited emergence of biosimilars could stabilize or slightly increase prices.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products: Fusilev. URL: (FDA website)
[2] IMS Health. (2022). Oncology drug market analysis.
[3] EvaluatePharma. (2023). Biosimilar and generic drug trend reports.
[4] Wolters Kluwer. (2022). US oncology therapeutics market overview.
