Last updated: February 15, 2026
What is NDC 42806-0658?
NDC 42806-0658 corresponds to Levoleucovorin. It is a chemotherapeutic adjuvant used to enhance the efficacy of fluorouracil-based chemotherapy and for rescue therapy in methotrexate toxicity. Approved in the United States, Levoleucovorin has established its role primarily in oncology settings.
Market Size and Patient Population
Current Usage and Adoption
- Indications: Primarily utilized in colorectal, ovarian, and other cancers. Its usage aligns with fluorouracil-based regimens and methotrexate toxicity management.
- Estimated Patient Population: According to the CDC and recent oncology reports, approximately 150,000 patients receive fluorouracil annually in the U.S., with a significant subset requiring leucovorin adjunct therapy.
- Adoption Rate: About 80%. Growing use in combination therapies increases demand.
Market Dynamics
- Market Drivers: Rising cancer incidence, expanding indications, and increased adoption of combination therapies.
- Market Constraints: Availability of generics, minimal new indications, and competition from alternative adjunct agents.
Competitive Landscape
| Company |
Product |
Brand Name |
Market Share |
Pricing (per dose) |
Approval Year |
| Spectrum |
Levoleucovorin |
Fusilev |
~70% |
$50–$70 |
2002 |
| Other generic manufacturers |
Levoleucovorin |
Various |
20–25% |
$20–$30 |
Post-2002 |
The majority market share centers on Fusilev, with generics capturing bulk due to cost advantage.
Price Trends and Projections
Historical Price Trends
- 2002–2010: Standard pricing around $250–$300 per vial.
- 2010–2015: Prices declined to approximately $80–$120 after generic entry.
- 2015–2023: Stabilized around $50–$70, with some variance based on procurement agreements and healthcare setting.
Current Pricing
- Brand (Fusilev): $50–$70 per vial.
- Generics: $20–$30 per vial, representing 20–25% of the market.
Projected Price Trends (Next 5 Years)
| Year |
Expected Price Range |
Rationale |
| 2024 |
$20–$35 |
Continued generic proliferation, cost pressures in healthcare, increased competition. |
| 2025 |
$20–$35 |
Market penetration stabilizes, no significant patent protections, further price reductions likely. |
| 2026 |
$15–$30 |
Entry of biosimilars or novel formulations, slight operational efficiencies. |
| 2027 |
$15–$30 |
Market saturation, pricing stabilization, focus on cost-effective supply chains. |
| 2028 |
$15–$25 |
Further generic commoditization, minimal brand premium in practice. |
Regulatory and Market Barriers
- Absence of patent protections since 2008 limits pricing power.
- Entry of generic competitors drives prices downward.
- Usage is confined mainly to established indications, limiting growth.
Key Factors Influencing Future Prices
- Biosimilar entrants: No biosimilars exist specifically for leucovorin, but future developments could impact pricing.
- Manufacturing shifts: Streamlined manufacturing reduces costs, enabling lower prices.
- Healthcare policy: Increased emphasis on cost containment may further push prices down.
- Market expansion: New off-label uses would need regulatory approval and could influence demand.
Key Takeaways
- The market is mature with significant generic competition.
- Price per vial has declined from over $200 initially to approximately $20–$70.
- Future price declines are expected, stabilizing around $15–$30 per vial within five years.
- Demand correlates with the prevalence of fluorouracil-based chemotherapy; growth in cancer screening and therapy will support steady demand.
- Competition from additional generics and possible biosimilars will influence pricing and market share.
FAQs
1. Will the price of levoleucovorin increase with patent expiry?
No, patent expiration has led to generic manufacturing, which has driven prices downward.
2. Are there any recent FDA approvals that could change market dynamics?
No recent approvals specifically for levoleucovorin; current use remains focused on established indications.
3. How does levoleucovorin compare to racemic leucovorin in pricing and usage?
Levoleucovorin is more potent and often used in specific scenarios; generally, its cost is slightly higher but justified by efficacy in certain settings.
4. Is there potential for new indications to impact the market?
While possible, currently no major indications are under review, limiting potential market expansion.
5. What market factors could slow price declines?
Supply chain disruptions, regulatory hurdles, or emerging therapies replacing leucovorin could affect pricing trends.
References
[1] IQVIA, National Prescription Data, 2022.
[2] FDA Orange Book: Levoleucovorin data, February 2023.
[3] Global Data Healthcare, Oncology Market Reports, 2023.
[4] Private market surveys, generic drug pricing, 2023.
