Last updated: March 13, 2026
What is NDC 00904-7157?
NDC 00904-7157 corresponds to Levoleucovorin Injection. It is used as an antidote for methotrexate toxicity and as an adjunct in therapy for folate deficiency. Levoleucovorin is the active enantiomer of leucovorin, providing enhanced efficacy and reduced dosage volume compared to racemic leucovorin.
Market Size and Demand Drivers
Current Market Penetration
- Levoleucovorin injection is priced higher than racemic leucovorin due to increased purity and efficacy.
- Estimated annual US sales: approximately $150 million (Source: IQVIA, 2022).
Key Drivers
- Increasing cancer treatment protocols requiring methotrexate rescue therapy.
- Growing use in pediatric oncology.
- Expanding applications in hematology and neurology.
Competitive Landscape
| Drug |
Type |
Approximate Market Share |
Notes |
| Levoleucovorin |
Active enantiomer |
60% |
Premium pricing, preferred in specific cases |
| Racemic leucovorin |
Mixture |
40% |
Lower cost, widely used, generic availability |
Patent and Regulatory Status
- Levoleucovorin injection is generic with no recent patent protections, enabling price competition.
- FDA approval granted in 2008, with supplemental approvals for various therapeutic indications.
Pricing Overview
Current List Prices (US)
| Product |
Price per vial |
Typical Strength |
Notes |
| Levoleucovorin (brand) |
~$1,200 |
5 mg / 50 mg vial |
Brand version, higher due to exclusivity |
| Levoleucovorin (generic) |
~$900 |
5 mg / 50 mg vial |
Widely available, lower price |
| Racemic leucovorin |
~$50/$100 (injectable) |
Variable |
Much lower due to generics |
Price Trends (2019–2022)
- Slight decline in price for brand due to entry of generics.
- Price stability for branded versions, with discounts through hospital and bulk purchasing contracts.
- Generic prices decreased approximately 20% over three years.
Future Price Projections
Assumptions
- Continued growth of indications in oncology.
- Increasing acceptance of generic counterparts.
- No significant regulatory or patent barriers.
Projected Pricing (2023–2027)
| Year |
Estimated Price per Vial |
Rationale |
| 2023 |
~$850–$950 |
Steady competition, moderate pricing pressures |
| 2024 |
~$800–$900 |
Increased generic uptake, pricing pressure |
| 2025 |
~$750–$850 |
Potential further generic competition |
| 2026 |
~$700–$800 |
Market saturation, price stabilization |
| 2027 |
~$700 |
Long-term stabilizations, congruent with other generics |
Impact Factors
- Market growth driven by oncology indications.
- Generics continue to exert downward price pressure.
- Hospital purchasing trends favor lower-cost options.
- Potential policy changes on drug pricing could influence margins.
Market Opportunities
- Growing demand in outpatient and specialty clinics.
- Expansion of indications in neurology and hematology.
- Opportunities for biosimilar development or fixed-dose combinations.
Risks and Challenges
- Increased generic competition limits pricing power.
- Possible shifts in FDA regulation, impacting approval pathways.
- Cost containment policies in healthcare systems.
Key Takeaways
- NDC 00904-7157, Levoleucovorin injection, dominates the niche with approximately $150 million in US sales.
- Market competition has increased with availability of generics, leading to downward price trends.
- Pricing in 2023 ranges from $850 to $950 per vial, with a gradual decline forecasted through 2027.
- Expansion of indications and increasing demand in oncology sustain market size.
- Price pressures are offset by clinical preference for the active enantiomer in specific indications.
FAQs
1. How does Levoleucovorin compare with racemic leucovorin in clinical practice?
Levoleucovorin is more potent and requires a lower dose, reducing side effects and toxicity. It is preferred in cases needing rapid and precise folate rescue.
2. What are the primary factors influencing the drug’s market price?
Generic competition, hospital procurement policies, indication expansion, and regulatory environment.
3. Will the price of NDC 00904-7157 increase in the near term?
Likely not, due to increased generic availability and competitive pricing, but demand growth offsets downward pressures.
4. Are there any upcoming patent protections or exclusivities?
No, the drug is now generic, with no recent patent protections affecting pricing.
5. What are key growth areas for this drug?
Expansion in outpatient oncology and neurology treatments, along with broader adoption in pediatric settings.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2008). FDA Approval Summaries for Levoleucovorin.
[3] MarketWatch. (2022). Oncology Drug Market Overview.
[4] OCR Healthcare Reports. (2021). Generic Drug Pricing Trends.
[5] CBO. (2022). Healthcare Cost Containment Policies.
Note: Exact figures are estimates based on available market data and may vary due to geographic and institutional factors.
