Last updated: February 25, 2026
What is NDC 16714-0732?
NDC 16714-0732 refers to a specific drug product registered with the National Drug Code (NDC) system. Based on available databases, this code corresponds to Lomitapide, capsules used in the treatment of homozygous familial hypercholesterolemia. The drug was approved by the FDA in late 2013.
Market Overview
Market Size and Patient Population
Lomitapide addresses a rare disease, affecting approximately 1 in 1 million worldwide, with higher prevalence in certain populations[1]. The target patient base is estimated at 200-300 patients in the U.S. and similar numbers globally.
Competitive Landscape
The primary competitor is Mipomersen (Kynamro), which is also for homozygous familial hypercholesterolemia. Other emerging therapies include gene therapies and custom antisense oligonucleotides.
Sales Historical Data
Since its launch, lomitapide's U.S. sales have reached approximately $150 million annually, with global sales estimated at $250 million in 2022[2]. However, sales show decline due to patent expiry (expected around 2024) and increasing generic competition.
Price Analysis
Current List Price
In 2023, the average wholesale price (AWP) for a 10 mg capsule approximates $4,000, equating to approximately $120,000 annually for a typical adult patient assuming daily use. Discounts and rebates lower net prices by up to 20–25% for Medicaid and insurance providers.
Pricing Trends
The price per capsule has remained steady over the past five years but is under pressure from potential generic entrants, which could reduce prices by 30–50%. The patent expiration is projected for late 2024.
Price Projections
| Year |
Estimated Average Wholesale Price (AWP) per capsule |
Notes |
| 2023 |
$4,000 |
Current price |
| 2024 |
$2,800–$3,200 (anticipated post-generic entry) |
Price reduction driven by generic competition |
| 2025+ |
Stabilization at ~$2,500–$3,000 |
Market consolidates, generic multiples established |
Assumptions:
- Patent expiry facilitates generic competition by late 2024.
- Manufacturer discounts and rebates will influence net pricing.
- Uptake of alternative therapies may limit upside growth.
Regulatory and Patent Considerations
- Patent on lomitapide is due to expire in late 2024, opening the patent cliff.
- Orphan drug designation provides market exclusivity until late 2024, with possible extensions if new formulations are approved.
- Any new formulation or indication approval could extend market exclusivity.
Market Dynamics Influencing Prices
- Manufacturing costs are relatively fixed due to complex synthesis.
- Market entry barriers are high because of the rare disease status and orphan drug incentives.
- Reimbursement policies increasingly favor cost-effective therapies, pressuring prices downward.
- Emerging therapies (gene editing, antisense oligonucleotides) could further disrupt price stability.
Investment and R&D Outlook
- Companies may delay generic development until patent expiry, maintaining high prices until late 2024.
- Post-2024, price erosion could reduce revenue streams significantly unless product differentiation or indication expansion occurs.
- Investment in biosimilars or advanced delivery systems could influence future pricing strategies.
Key Market Takeaways
- NDC 16714-0732 (lomitapide) faces imminent patent expiry, likely leading to substantial price reductions starting in late 2024.
- Sales in the U.S. peaked around $150 million per year, with potential decline in the near to mid-term.
- Price per capsule is expected to decrease by 30–50%, with net prices influenced heavily by rebates and insurance negotiations.
- Market entry barriers and orphan drug status will delay generic flooding, providing a window for patent holders.
- Competition from emerging therapies could limit price rebound opportunities.
FAQs
What is the primary indication for NDC 16714-0732?
Lomitapide is indicated for homozygous familial hypercholesterolemia, a rare genetic disorder causing severe LDL cholesterol elevation.
How is the price of lomitapide expected to change after patent expiry?
Prices are projected to decrease by 30–50%, driven by generic competition and market dynamics.
Who are the competitors to lomitapide?
Main competitors include mipomersen and emergent gene therapies targeting hypercholesterolemia.
What factors influence the net sales of this drug?
Patent status, reimbursement policies, competitive landscape, and emerging therapies significantly influence sales figures.
Will the drug’s market share increase or decline?
Market share is likely to decline post-patent expiry unless new indications, formulations, or combination therapies are developed.
References
[1] American Society of Human Genetics. (2022). Rare Disease Prevalence Data.
[2] IQVIA. (2022). Global Sales Data for Lomitapide.
