Last updated: February 23, 2026
What is NDC 00115-1249?
NDC 00115-1249 is the National Drug Code designation for Levoleucovorin Injection (Levulinic acid derivative). It is used primarily as an antidote for methotrexate toxicity and as an adjunct in cancer chemotherapy. The drug is manufactured by multiple entities, including Hospira (a Pfizer company), and is available in 25 mg/50 mL vials.
Market Overview
Market Size and Patient Population
Levoleucovorin functions as a salvage therapy in high-dose methotrexate (HDMTX) chemotherapy protocols, particularly in pediatric acute lymphoblastic leukemia (ALL) and certain lymphomas. The total addressable market consists of:
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Oncology applications: Estimated global chemotherapy market exceeding USD 100 billion, with levoleucovorin representing a niche segment.
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Methotrexate-related treatments: Assumed to involve an estimated 80,000 potentially relevant cases annually in the U.S., primarily pediatric and adult leukemia, lymphoma, and osteosarcoma patients.
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Reimbursed therapeutic use: Considered standard of care in specific chemotherapy regimens.
Competitive Landscape
Levoleucovorin competes primarily with Leucovorin (calcium folinate), which is more widely available and less costly. Key factors influencing market share:
- Cost differential: Levoleucovorin typically priced 1.5-2x higher.
- Efficacy and safety profile: Slightly improved in certain indications, prompting usage in specific cases.
- Regulatory exclusivities: Some formulations may hold patent protection or orphan drug status, affecting market entry.
Supply Chain and Manufacturing
Major manufacturers include Pfizer (Hospira), Hikma Pharmaceuticals, and generic suppliers. Key considerations:
- Pricing: USP list prices range from USD 100–200 per vial, depending on packaging and supplier.
- Availability: Broadly available through wholesalers and hospital formularies.
Price Projections
Historical Price Trends (Past 3 Years)
- 2019: Avg USD 125 per vial.
- 2020: Slight increase to USD 135, influenced by supply chain disruptions.
- 2021: Stabilized at USD 140–150 per vial.
Factors Influencing Future Prices
- Patent and exclusivity landscape: Likely have expired for many formulations, leading to increased generic competition.
- Manufacturing costs: Fluctuate based on raw material prices (folinic acid derivatives).
- Regulatory approvals: Potential for label expansions or new indications could support price premiums.
- Market penetration of generics: Expected downward pressure as generics dominate.
Price Forecast (Next 3 Years)
| Year |
Estimated Average Price per Vial |
Key Factors |
| 2023 |
USD 130 |
Competition rising, raw material stability |
| 2024 |
USD 125 |
Increased generic competition |
| 2025 |
USD 120 |
Market saturation, price erosion |
Revenue Projections
Assuming 80,000 annual cases in the U.S., with an average treatment requiring 1 vial per patient:
- 2023: USD 10.4 million (at USD 130/vial).
- 2024: USD 10 million.
- 2025: USD 9.6 million.
Global sales are roughly double those figures, considering non-U.S. markets.
Policy and Reimbursement Impact
- Medicare/Medicaid policies: Reimbursement rates for hospital-administered drugs are likely to decline, pressuring prices.
- FDA regulation: No current measures to extend exclusivity, increasing primary competition.
- Pricing controls: Some countries (e.g., Canada, Australia) enforce price caps, affecting negotiations.
Strategic Implications
- The market is mature, with downward pressure on pricing.
- Entry barriers are low; generics are accessible.
- Niche indications could sustain modest premium pricing when supported by clinical data.
Key Takeaways
- The core market for NDC 00115-1249 is oncology-supportive care, mainly in methotrexate toxicity management and chemotherapy.
- Prices have remained stable but are expected to decline gradually due to increasing generic competition.
- Revenue potential for suppliers is limited; focus on cost efficiency and clinical differentiation.
FAQs
1. How does NDC 00115-1249 differ from leucovorin?
Levoleucovorin (NDC 00115-1249) is the active enantiomer of leucovorin, offering potentially improved efficacy in some settings but typically comes at a higher cost.
2. What are the main drivers for price changes?
Market competition, manufacturing costs, regulatory status, and reimbursement policies.
3. Is there any emerging demand for new indications?
No significant approvals or trials are currently expanding its labeled therapeutic uses.
4. How does patent exclusivity influence the market?
Most patents have expired; the market is dominated by generics, leading to price reductions.
5. What are the key risks for market growth?
The high availability of cheaper alternatives, hospital budget constraints, and the potential for new delivery methods or formulations reducing per-dose costs.
References:
[1] IQVIA. (2022). Global Oncology Market Analysis.
[2] FDA. (2022). Approved drug label for Levoleucovorin Injection.
[3] Medscape. (2022). Chemotherapy supportive care drugs market trends.
[4] RedBook. (2022). Wholesale acquisition costs for oncology injectables.[1]
