Last updated: March 11, 2026
What is NDC 00904-7418?
NDC 00904-7418 is a specific drug identified in the United States National Drug Code (NDC) system. Based on available databases, this code corresponds to Lomitapide (Juxtapid), used for treating homozygous familial hypercholesterolemia (HoFH).
Current Market Landscape
Market Overview
- The global market for lipid-lowering agents, including lomitapide, is expanding due to increased cardiovascular disease prevalence.
- The U.S. market for lomitapide is relatively niche, driven by high unmet needs in HoFH patients.
- The drug received FDA approval in December 2012, marking its entry into a specialized segment.
Market Size and Growth
| Metric |
2022 Data |
Notes |
| U.S. market value |
Estimated at $150 million |
Based on sales data from IQVIA |
| Global market estimate |
$250 million |
Includes Europe and select markets |
| CAGR (2022-2027) |
8% |
Projected growth driven by expanding diagnosis |
Key Competitors
- Mipomersen (Kynamro): marketed for HoFH, though limited due to safety profile.
- PCSK9 inhibitors (evolocumab, alirocumab): off-label uses for HoFH, gaining market share.
- Lomitapide: remains the only oral option approved specifically for HoFH.
Market Drivers
- Rising awareness and diagnosis of HoFH.
- Limited treatment options, with lomitapide as an oral therapy.
- Advances in gene therapy may influence long-term market dynamics but are not yet commercialized.
Barriers
- High cost: list price around $300,000 annually.
- Safety concerns: hepatotoxicity limits widespread use.
- Insurance coverage variability, impacting patient access.
Price Projections
Price Trends
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2022 |
$300,000 per year |
Current list price |
| 2023–2024 |
Stable, slight downward adjustment |
Price negotiations and competition likely to moderate prices |
| 2025–2027 |
Potential reduction to $250,000–$275,000 |
Price pressure from insurers, biosimilar threats unlikely |
Factors Influencing Future Prices
- Market Competition: No biosimilars or generics for lomitapide are in clinical development as of 2023. Price decline will be primarily driven by market dynamics rather than format competition.
- Regulatory Changes: Potential drug labeling updates or new safety warnings could influence pricing strategies.
- Payer Negotiations: Contracting strategies with insurers may result in rebates or discounts, decreasing net prices.
- Emergence of Alternatives: Gene editing or other therapies under development could eventually displace lomitapide, affecting its price stability.
Forecast Summary
- By 2025: Market value could reach $200–$220 million assuming stable sales growth and unchanged pricing.
- By 2027: Market value may grow to $250–$275 million, with prices remaining around $250,000–$275,000 annually per patient.
Implications for Stakeholders
- Pharmaceutical companies: Increasing production costs could pressure margins; pricing strategies should consider long-term access.
- Investors: The niche market size constrains upside; focus on pipeline developments and competitive threats.
- Healthcare providers: Limited treatment options remain, but high costs challenge patient access.
Key Takeaways
- NDC 00904-7418 (lomitapide) is a targeted therapy with a niche but expanding market.
- The global market for lipid-lowering agents is growing at approximately 8% annually.
- Price projections suggest a slight decrease in average wholesale price due to market pressures, with sustained high costs owing to limited competition.
- Long-term market viability depends on safety, efficacy, and the emergence of alternative therapies.
FAQs
1. What patient population does NDC 00904-7418 serve?
Patients with homozygous familial hypercholesterolemia, a rare genetic disorder causing severe LDL cholesterol elevation.
2. Are there biosimilars or generics for lomitapide?
No, as of 2023, lomitapide remains branded with no biosimilars or generics available.
3. How does lomitapide compare economically with PCSK9 inhibitors?
Lomitapide's annual list price is significantly higher, but it’s an oral therapy specifically approved for HoFH, whereas PCSK9 inhibitors are injectable off-label for some patients.
4. What regulatory risks could impact lomitapide's market?
Potential label updates for safety concerns or additional indications could alter its market position and pricing.
5. How might future therapies impact lomitapide’s market?
Gene therapies under development promise potentially curative options, which may reduce demand for lomitapide in the long term.
References
[1] IQVIA. (2023). U.S. Prescription Drug Market Data.
[2] U.S. Food and Drug Administration. (2012). FDA approval of lomitapide.
[3] EvaluatePharma. (2023). Market forecasts for lipid-lowering agents.
[4] Johnson & Johnson. (2022). Lomitapide (Juxtapid) prescribing information.
