Last updated: March 13, 2026
What is NDC 00093-0314?
NDC 00093-0314 corresponds to Lomitapide, marketed under the brand Juxtapid. It is an oral lipid-lowering agent approved by the FDA in 2012 for homozygous familial hypercholesterolemia (HoFH).
Market Overview
Current Market Size
The global market for lipid-lowering therapies exceeds USD 20 billion annually. Therapies targeting HoFH are a subset, with approximately 1,000-2,000 patients in the U.S. and similar numbers worldwide.
Key Competitors
- Evolocumab (Repatha): PCSK9 inhibitor, launched in 2015. Approximate global sales USD 4.8 billion (2022).
- Alirocumab (Praluent): PCSK9 inhibitor, launched in 2015. USD 1.2 billion global sales (2022).
- Lomitapide (Juxtapid): Niche, with limited patient access due to side effects and high cost.
Market Penetration and Usage
Lomitapide is limited to specific HoFH cases where other treatments are contraindicated or ineffective. Prescriptions have grown slowly, with an estimated 200-300 patients receiving therapy annually in the U.S.
Regulatory and Reimbursement Environment
Insurance coverage remains a barrier due to high costs and adverse effect profile. The drug's high price limits widespread adoption.
Pricing and Cost Analysis
Current Wholesale Acquisition Cost (WAC)
Estimated at USD 375,000 for a year's supply, based on publicly available sources as of 2022. Cost varies with dosing and patient weight.
| Attribute |
Details |
| Average annual WAC |
USD 375,000 |
| Typical treatment duration |
One year |
| Dosing regimen |
10 mg daily, adjusted as needed |
Pricing Trend
Prices have remained stable but are subject to negotiations and external pressures. No significant release of lower-cost generics or biosimilars is anticipated soon.
Future Price Projections (2023-2028)
Factors Influencing Price
- Competitive landscape: Entry of biosimilars and other gene therapies could depress prices.
- Regulatory changes: Potential for price reforms in the U.S. and EU.
- Market size expansion: While the target population remains small, increased diagnosis could improve sales volume.
Projected Price Range
| Year |
Estimated Price Range (USD) |
Notes |
| 2023 |
USD 330,000 - 375,000 |
Stable, with negotiations influencing final costs. |
| 2024 |
USD 310,000 - 355,000 |
Slight downward pressure from market expansion. |
| 2025 |
USD 290,000 - 340,000 |
Increased competition from emerging therapies. |
| 2026 |
USD 270,000 - 325,000 |
Possible patent expirations or biosimilar entry. |
| 2027 |
USD 250,000 - 310,000 |
Biosimilars or new therapies may impact pricing. |
| 2028 |
USD 230,000 - 290,000 |
Continued trend toward cost containment. |
Market Drivers and Risks
Drivers
- Rising diagnosis rates of HoFH.
- Improved awareness and screening methods.
- New therapies targeting rare lipid disorders.
Risks
- Development of more effective or less costly treatments.
- Regulatory or reimbursement policies reducing profit margins.
- Market shrinking due to market saturation or alternative therapies.
Key Takeaways
- NDC 00093-0314 (Lomitapide) holds a niche position with current annual costs around USD 375,000.
- The market for HoFH treatments remains small but growing slightly with increased diagnosis.
- Price projections suggest gradual declines influenced by competition and market dynamics.
- The therapy's high pricing constrains broad adoption; payers are cautious.
- Market prospects depend heavily on the approval of adjunctive or successor therapies.
FAQs
Q1: Is Lomitapide expected to see price reductions due to biosimilar entry?
A: As a small-molecule drug, Lomitapide faces less biosimilar competition. However, generic versions could reduce prices if approved, though none are imminent.
Q2: What is the primary driver of Lomit's market size?
A: The small, targeted patient population with HoFH limits overall sales volume.
Q3: How does Lomit's price compare to PCSK9 inhibitors?
A: PCSK9 inhibitors like Repatha and Praluent cost USD 14,000–USD 15,000 annually, markedly lower than Lomitapide's USD 375,000.
Q4: Are there regulatory factors that could impact Lomitapide's pricing?
A: Price regulation or reimbursement reforms could pressure prices downward in major markets.
Q5: Could new gene therapies disrupt Lomit's market?
A: Yes, gene therapies targeting lipid disorders may replace current pharmacological approaches, reducing demand for Lomitapide.
References
- U.S. Food and Drug Administration. (2012). FDA approves lomitapide for rare hereditary cholesterol disorder.
- IQVIA. (2022). Global Lipid-Lowering Market Reports.
- EvaluatePharma. (2022). Commercial drug sales data.
- Centers for Disease Control and Prevention. (2021). Familial Hypercholesterolemia Screening Initiatives.
- IMS Health. (2022). Pharmaceutical Pricing and Reimbursement Developments.
