Last updated: February 26, 2026
What is NDC 23155-0858?
NDC 23155-0858 corresponds to Lomitapide (brand name Juxtapid), an oral lipid-lowering agent. It is approved by the FDA for the treatment of Homozygous Familial Hypercholesterolemia (HoFH). The drug belongs to the class of microsomal triglyceride transfer protein (MTP) inhibitors.
Market Overview
Indications and Patient Population
- Homozygous Familial Hypercholesterolemia (HoFH) is a rare genetic disorder affecting approximately 1 in 1 million individuals globally.
- Estimated prevalence in the U.S.: 1,300 to 1,500 patients.
- Untreated HoFH patients face a high risk of premature cardiovascular disease, making effective lipid-lowering therapy critical.
Competitive Landscape
- Existing therapies: PCSK9 inhibitors (e.g., evolocumab, alirocumab), lomitapide (same active ingredient), LDL apheresis.
- Market share: Lomitapide holds a niche segment due to severe contraindications and adverse effect profiles associated with its use.
Regulatory Status
- Approved in the U.S. in December 2012.
- Expanded to include pediatric patients aged ≥6 years in 2019.
Revenue Factors
- Market penetration remains limited due to:
- High cost
- Stringent monitoring requirements
- Adverse events (e.g., hepatotoxicity, gastrointestinal effects)
- Estimated annual sales in 2022: approximately $80–120 million (IBISWorld, 2022).
Price and Cost Analysis
Current Pricing
- List price: Approximately $447,500 per year for a typical treatment course (based on the FDA-approved dosage, 10 mg daily).
- Wholesale acquisition cost (WAC): Similar to list price; actual net prices vary due to discounts and rebates.
Cost-Effectiveness and Reimbursement
- Reimbursement: Typically through Medicare, Medicaid, and private insurers.
- Coverage barriers: Constrain accessibility, limiting overall market size.
Price Projections (Next 3–5 Years)
| Year |
Estimated Price Range |
Rationale |
| 2023 |
$440,000 – $460,000 |
Steady pricing with minor adjustments for inflation and rebates |
| 2024 |
$440,000 – $470,000 |
Slight increase reflecting market dynamics and potential new formulations |
| 2025 |
$440,000 – $480,000 |
Anticipated handling of biosimilars or alternative therapies influencing pricing |
Market Growth Drivers
- New formulations or delivery methods could positively impact affordability and adherence.
- Expansion into pediatric populations increases potential patient base.
- Emerging biosimilars or generic MTP inhibitors may exert downward pressure after patent expiration (~2027–2028).
Patent and Regulatory Outlook
- Patent protection expires around 2028, allowing for potential biosimilar or generic competition.
- Regulatory agencies may approve expanded indications, increasing market size.
Key Market Risks
- Safety concerns and side effects limit widespread use.
- Competitive drugs with better tolerated profiles could erode market share.
- Cost containment policies by healthcare systems may restrict reimbursement rates.
Conclusions
- NDC 23155-0858 (Lomitapide) remains a niche drug with annual sales around $80–120 million.
- Pricing is stable, with slight increases projected annually.
- The market faces impending generic competition and biosimilar entry, likely reducing prices over the next 3–5 years.
Key Takeaways
- The drug's high list price limits overall accessibility.
- Market growth depends on expanding indications and formulations.
- Competition from biosimilars will influence pricing post-2028.
- Insurance reimbursement remains a critical factor for market penetration.
- Safety profile considerations restrict widespread adoption.
FAQs
1. How is the price of Lomitapide determined?
Pricing relies primarily on manufacturing costs, market exclusivity, and the value provided in managing such a rare disease. The list price set by the manufacturer aims to reflect the innovation and limited competition but is kept high due to its orphan drug status.
2. Are there factors that could lead to price reduction?
Introduction of biosimilars, regulatory approval for broader indications, or negotiated discounts through insurance providers could lower effective prices.
3. What is the typical reimbursement process for this drug?
Reimbursement varies by payer; insurers evaluate cost-effectiveness, safety profiles, and clinical need before approving coverage and formulary placement.
4. How does Lomitapide compare with other therapies?
It offers unique benefits for HoFH but faces competition from PCSK9 inhibitors and LDL apheresis, especially when considering side effects and cost.
5. What is the future outlook for Lomitapide?
Market growth may be limited without new formulations or expanded indications. Patent expiration around 2028 could introduce biosimilar competition, reducing prices.
References
- IBISWorld. (2022). Market report: Rare disease pharmaceuticals.
- FDA. (2012). Juxtapid prescribing information.
- MedTrack. (2022). Drug patent expiry and biosimilar timelines.
- American Society of Human Genetics. (2021). HoFH prevalence data.
- IQVIA. (2022). U.S. pharmaceutical sales data for orphan drugs.
[Note: Data presented are estimates based on available market research and regulatory filings as of 2023.]
