Last updated: March 13, 2026
What is NDC 00115-9941?
NDC 00115-9941 refers to a specific drug product registered under the National Drug Code (NDC) system. It corresponds to Levoleucovorin (generic name), used as a chemoprotective agent, adjutant in chemotherapy, and in treating folate deficiency. Levoleucovorin is the active enantiomer of leucovorin and often marketed as a more targeted alternative.
This analysis evaluates the current market landscape, competitive positioning, pricing strategies, and future price projections for Levoleucovorin.
Market Overview
Market Size and Revenue Estimates
The global chemotherapy adjuncts market, which includes folate derivatives like Levoleucovorin, is valued at approximately $2.8 billion in 2022. The segment specific to leucovorin products is estimated at $200 million, with Levoleucovorin representing a growing subset due to favorable efficacy and safety profile.
Key Therapeutic Uses
- Cancer chemotherapy: As a rescue agent for methotrexate toxicity.
- Folate deficiency treatment.
- Adjunct in hypercalcemia of malignancy.
Major Market Players
- Fresenius Kabi: Offers a branded Levoleucovorin product.
- Horizon Pharma: Markets a branded version under the name Fusilev.
- Sandoz and other generics manufacturers.
The top four players hold over 75% of the market share. Established distribution networks and hospital contracts heavily influence pricing and market penetration.
Regulatory Environment
- FDA approval: Levoleucovorin (Fusilev) received approval in 2008.
- Market exclusivity: Sandoz’s generic versions face patent expiry, opening the market to biosimilars and generics.
- Pricing policies: Government and insurance pricing negotiations impact net prices.
Price Landscape
Current Pricing Dynamics
| Product |
Formulation |
List Price (per vial) |
Number of Vials per Treatment |
Remarks |
| Fusilev (Horizon Pharma) |
50 mg/mL, 5 mL vial |
~$980 |
1 vial for typical dose |
Premium brand, higher net price after negotiations |
| Generic Levoleucovorin |
50 mg/mL, 5 mL vial |
~$560–700 |
1 vial for typical dose |
Widely available, more price competitive |
Price Comparison with Leucovorin
Levoleucovorin's price is approximately 20-40% higher than racemic leucovorin, justified by increased potency and targeted activity.
Reimbursement and Insurance Impact
Coverage varies by payer, with private insurers reimbursing close to list prices, while Medicaid and Medicare negotiate discounts. Reimbursement often limits hospital procurement costs.
Market Dynamics and Future Projections
Key Drivers
- Growing cancer incidence: Oncology drugs represent 65% of the growth.
- Shift towards targeted therapies: Increased use of Levoleucovorin as an adjunct.
- Patent expirations: Brands like Fusilev face biosimilar competition post-2024.
- Pricing pressures: Payers push for lower prices, incentivizing generics.
Price Projections (2023–2030)
| Year |
Estimated Price Range (per vial) |
Factors Influencing Prices |
| 2023 |
$540–$700 |
Patent expiry, biosimilar emergence, negotiated discounts |
| 2025 |
$520–$670 |
Increased biosimilar competition, hospital procurement negotiations |
| 2030 |
$480–$620 |
Market saturation, expanding biosimilar options, cost containment policies |
Trends
- Gradual decline in list prices expected due to biosimilar competition.
- Price stabilization expected by 2028 when biosimilar market share plateaus.
- Volume growth driven by expanded indications and increased cancer treatment prevalence.
Conclusion
NDC 00115-9941, representing Levoleucovorin, faces significant pricing pressure from biosimilars and generic competition. While current prices reflect brand premium and efficacy, future prices are projected to decline moderately, stabilizing around 10-15% below current levels by 2030, depending on biosimilar market trajectory.
Key Takeaways
- The Levoleucovorin market is valued at approximately $200 million, with growth driven by oncology and folate deficiency indications.
- The current average price per vial ranges from $560 to $980, with generics pricing significantly lower than branded options.
- Biosimilar entrants post-2024 are expected to push prices downward, with stable prices established by 2028.
- Market penetration remains high in hospital settings, where negotiated discounts influence net prices.
- Expansion into new indications and increased cancer prevalence support volume growth but not necessarily higher prices.
FAQs
1. What factors most influence Levoleucovorin's price?
Patent status, biosimilar competition, hospital procurement negotiations, and payer reimbursement policies.
2. How do biosimilars impact the market?
They increase competition, reduce list and net prices, and expand access by lowering costs.
3. Is Levoleucovorin more cost-effective than leucovorin?
Yes, due to greater potency and targeted action, leading to potentially lower required doses.
4. What are the primary channels for market access?
Hospital and oncology infusion centers through direct procurement and negotiated discounts.
5. What is the forecast for Levoleucovorin market growth?
A compound annual growth rate (CAGR) of 3–5% through 2030, driven by increased cancer treatment prevalence.
Citations
- MarketsandMarkets. (2022). Oncology drugs market size, share & trends analysis.
- U.S. Food and Drug Administration. (2008). FDA approval documents for Fusilev.
- IQVIA. (2022). National Prescription Audit Data.
- Future Market Insights. (2023). Biosimilar market forecasts.
- FDA. (2022). Biosimilar and interchangeable products guidance.
[1] MarketsandMarkets. (2022). Oncology drugs market size, share & trends analysis.
