Last updated: February 23, 2026
What Is the Drug Associated with NDC 47918-0898?
NDC 47918-0898 is assigned to Levoleucovorin injection. Levoleucovorin is a folate analog used as an adjunct in chemotherapy, particularly with methotrexate, and as a rescue agent to reduce toxicity from high-dose methotrexate therapy. It is the purified enantiomer of leucovorin (folinic acid), offering potentially improved pharmacokinetics and efficacy.
Current Market Landscape
Market Size and Demand
- The U.S. oncology drug market exceeds $20 billion annually, with folate analogs representing a niche but vital segment.
- Levoleucovorin injections primarily serve oncology centers and hospitals, with limited outpatient use.
- Usage is driven by high-dose methotrexate protocols for central nervous system cancers (e.g., osteosarcoma, certain leukemias).
Competition and Market Share
| Product |
Manufacturer |
Price (per vial) |
Market Notes |
| Levoleucovorin injection (NDC 47918-0898) |
Fresenius Kabi |
~$70–$120 |
Available generically or via branded sources; recent market entry reduces price |
| Leucovorin calcium injection |
Teva, Amneal, others |
~$50–$100 |
Widely used, more established |
Note: Pricing varies by supplier, procurement volume, and contractual agreements.
Regulatory Status
- FDA approved; indication limited to adjunct in chemotherapy and toxicity mitigation.
- No generic exclusivity, but market entry by generics has driven prices downward over the past five years.
Price Trends and Projections
Historical Pricing Data (Last 5 Years)
- 2018: Approximate price per 10 mg vial was $100–$130.
- 2020: Prices declined to $80–$110 with increased generic competition.
- 2022–2023: Prices stabilized around $70–$100, with some suppliers offering lower prices for bulk purchases.
Factors Influencing Future Pricing
- Generic Competition: Increased penetration lowers prices; expected to continue in the next 2–3 years.
- Manufacturing Costs: Stable due to established biosynthetic processes; no significant upward pressure.
- Market Demand: Stable, but niche; growth limited by the prevalence of indications.
- Regulatory Changes: No imminent changes expected that impact pricing or availability.
Price Projection (Next 3 Years)
| Year |
Estimated Price Range (per vial, 10 mg) |
Notes |
| 2024 |
$65–$95 |
Increased generic market share; price stability |
| 2025 |
$60–$90 |
Continued generic competition and large-volume contracts |
| 2026 |
$60–$85 |
Market saturation; minor price reductions |
Price reductions may be offset by inflation in manufacturing costs or supply chain disruptions but are unlikely to rise without new indications or formulations.
Market Drivers and Barriers
Drivers
- Use in high-dose methotrexate therapy for cancers.
- Hospital procurement agreements favoring volume discounts.
- Non-availability of multiple branded options limits price competition.
Barriers
- Limited outpatient use reduces overall volume.
- Rarity of indications constrains market expansion.
- Potential biosimilar or novel agents could introduce pricing pressure.
Conclusion
Levoleucovorin injection (NDC 47918-0898) operates within a constrained market. Prices have trended downward due to generic competition, with an anticipated stable or slightly declining trajectory over the next three years. Market growth remains limited to existing high-dose chemotherapy protocols, preventing significant revenue expansion.
Key Takeaways
- Levoleucovorin is primarily used in oncology protocols, with a niche but stable demand.
- Prices declined from approximately $100–$130 per 10 mg vial in 2018 to about $70–$100 in 2023.
- Competitive pressures and generic entry are the main factors driving prices lower.
- Future prices are projected to remain in the $60–$90 range, with minimal upward pressure.
- Market growth is limited; pricing mainly influenced by hospital procurement practices and generic competition.
FAQs
1. What factors most influence the price of levoleucovorin injection?
Market competition, especially generics, demand volume, hospital procurement contracts, and manufacturing costs.
2. Are there any upcoming patent expirations or exclusivity periods?
Levoleucovorin's patent has expired; multiple generics are available, maintaining price pressure.
3. How does levoleucovorin compare to leucovorin calcium?
Levoleucovorin is a purer enantiomer with potentially better pharmacological properties, but cost differences are minimal in the injectable form.
4. What is the primary market for this drug?
Hospitals and infusion centers administering high-dose chemotherapy for cancers such as osteosarcoma and certain leukemias.
5. Are biosimilars or new formulations expected to alter the market?
No large-scale biosimilar development is currently announced; improvements are primarily through existing generics and volume-based pricing.
References
- IQVIA. (2022). U.S. Oncology Market Data.
- FDA. (2022). Levoleucovorin Injection Approval and Labeling.
- GoodRx. (2023). Leucovorin Injection Prices.
- FDA. (2021). Generic Drug Approvals and Market Entry.
- Statista. (2023). Pharmaceuticals Market Overview.
