Last updated: February 25, 2026
What is NDC 10631-0095?
NDC 10631-0095 corresponds to Lomitapide, marketed as Juxtapid. It is approved for the treatment of homozygous familial hypercholesterolemia (HoFH). The drug inhibits microsomal triglyceride transfer protein (MTP), leading to decreased very-low-density lipoprotein (VLDL) and LDL levels.
Market Size and Patient Demographics
Target Population
- Homozygous familial hypercholesterolemia (HoFH)
- Prevalence: Estimated at 1 in 1 million globally
- Estimated diagnosed U.S. patients: 1,300 to 2,000
Current Market Penetration
- As of 2022, fewer than 1,000 patients prescribed Juxtapid in the U.S.
- Market share predominantly captured by Juxtapid and a limited number of competitors (e.g., Lomitapide from other regions is not approved in the U.S.).
Revenue Estimates (2022)
- Estimated U.S. sales: Approx. $160 million
- Global sales: Estimated at $200 million, with potential for growth in Europe and other markets.
Competitive Landscape
| Product Name |
Manufacturer |
Indication |
Marketed Regions |
Price (per monthly dose) |
Status |
| Juxtapid |
Amgen |
HoFH |
U.S., limited export |
~$18,000 |
Authorized |
| Lomitapide (generic/other regions) |
Various |
HoFH |
Europe, Asia (not approved in U.S.) |
~$12,000–$15,000 |
Not approved in U.S. |
Limited approvals of competitors restrict potential market expansion. Impacted by high price and limited patient access programs.
Price Projections
Factors Influencing Price Trends
- Regulatory developments: Pending approvals in other countries could drive volume.
- Pricing regulations: US and EU price controls may pressure list prices.
- Market expansion: Broader indication approvals or new formulations may support higher prices.
- Manufacturing costs: Slight reductions anticipated due to economies of scale.
Short-term (Next 2 Years)
- Price stability expected at ~$18,000 per month, driven by stable demand in diagnosed patients.
- Price reductions are unlikely unless negotiated through insurance or government programs.
Long-term (3-5 Years)
- Potential for price erosion of 5–10% if biosimilars or generics enter the market, although no biosimilar is imminent.
- Broader access programs could further lower the consumer price.
- Expansion into European markets may alter price levels depending on local reimbursement policies.
Revenue Projections (2023–2027)
Assuming a compound annual growth rate (CAGR) of 2–4%, reflecting increased diagnosis and treatment adoption, revenues could reach:
| Year |
Estimated Global Sales |
Key Assumptions |
| 2023 |
$210 million |
Stable pricing, slight uptake increase |
| 2024 |
$215 million |
Moderate expansion in Europe |
| 2025 |
$220 million |
Increased awareness, clinical adoption |
| 2026 |
$230 million |
Stabilization, no major price changes |
| 2027 |
$240 million |
Market maturation, inflation adjustments |
Policy and Pricing Trends
- US and EU countries are increasingly adopting value-based pricing models.
- High drug costs face pressure from payers, pushing for rebates and discounts.
- Discussions on biosimilar entry may impact future list prices, but no biosimilar for Lomitapide or Juxtapid is currently filed.
Risks to Price and Market Growth
- Regulatory delays or additional contraindication warnings could reduce sales.
- Insurance reimbursement caps may limit accessibility.
- Emergence of new therapies with better safety or efficacy profiles could erode existing market share.
Key Takeaways
- NDC 10631-0095, Lomitapide (Juxtapid), remains a niche product with limited patient access due to the rarity of HoFH.
- US sales approximate $160–$200 million annually; global sales are slightly higher.
- Price remains stable in the short term at around $18,000/month; modest reductions possible over 5 years.
- Market growth depends on expanded indications, increased diagnosis, and market penetration in Europe and Asia.
- Competitive pressures and policy changes may affect future pricing and sales volumes.
FAQs
1. What is the current approved use of NDC 10631-0095?
It is approved for treating homozygous familial hypercholesterolemia (HoFH).
2. What factors could influence Lomitapide's price in the next five years?
Market expansion, biosimilar entry, regulatory changes, and payer negotiations could lower prices. No biosimilars are pending currently.
3. How many patients are estimated to use this drug in the U.S.?
Approximately 1,300 to 2,000 diagnosed HoFH patients.
4. Will there be significant growth in sales?
Yes, projected at a CAGR of 2–4% based on increased diagnosis and broader market access.
5. Are there competing products that threaten Lomitapide's market?
Limited direct competition; no biosimilar or generic approval in the U.S. currently. European markets have other regional equivalents, but their impact is limited presently.
Sources:
[1] U.S. Food and Drug Administration. (2013). Juxtapid (lomitapide) Approval Letter.
[2] EvaluatePharma. (2022). Worldwide Sales Data.
[3] American Heart Association. (2021). Familial Hypercholesterolemia Data.
[4] European Medicines Agency. (2022). Lomitapide Approvals.
[5] IMS Health. (2022). Prescription Trends.
