Last updated: February 27, 2026
What is NDC 31722-0934?
NDC 31722-0934 registers a drug marketed under the US National Drug Code system. Based on available data, this code corresponds to Nexletol (bempedoic acid), developed by Esperion Therapeutics. Nexletol is approved for reducing LDL cholesterol in adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who need additional lowering of LDL cholesterol.
Market Overview
Indications and Competitive Landscape
- Indications: Hypercholesterolemia in specific patient populations.
- Market size: The global cholesterol-lowering drugs market was valued at approximately $14 billion in 2022.
- Competitors:
- Statins (e.g., atorvastatin, rosuvastatin)
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Other non-statin agents (e.g., ezetimibe, inclisiran)
Adoption and Reimbursement
- Nexletol’s adoption depends on prescriber awareness and insurance coverage.
- Reimbursement policies typically align with cholesterol management guidelines, impacting patient access.
- As of 2023, the drug's reimbursement has improved gradually, reflecting positive clinician feedback and favorable insurance policy updates.
Sales Performance
- Estimated US sales in 2022: approximately $300 million.
- Sales are projected to increase in the next five years, driven by expanded indications, increased prescribing, and competitive positioning.
Price Analysis and Projections
Current Pricing Data
- Wholesale Acquisition Cost (WAC): Approximate monthly WAC for Nexletol ranges from $595 to $620 per 30-tablet supply (per month).
- Average wholesale price (AWP): Typically 20-30% higher than WAC.
Price Trends
| Year |
Estimated Price Range (Monthly) |
Notes |
| 2022 |
$595 – $620 |
Launch year, initial pricing. |
| 2023 |
Slight increase (~2-3%) |
Due to inflation, supply chain, and market dynamics. |
| 2024 – 2025 |
$620 – $640 |
Potential stability, barring significant patent or regulatory shifts. |
Market Pricing Influences
- Introduction of generic bempedoic acid or biosimilar entrants could reduce prices.
- Reimbursement negotiations may further affect net prices.
- Market competition from PCSK9 inhibitors or emerging therapies may pressure pricing.
Price Projection Model
Based on current growth, market adoption, and industry trends, the following projections reflect potential average monthly prices:
| Year |
Projected Prices |
Rationale |
| 2026 |
$640 – $660 |
Moderate increase, stable patent protection. |
| 2027 |
$660 – $680 |
Continued inflation adjustments, no generic entry. |
| 2028 |
$680 – $700 |
Possible slight drop if biosimilar or generic versions enter market, or new competitors gain market share. |
Revenue Impact Forecast
- As the drug’s market share grows to cover 20-25% of the cholesterol-lowering segment (from 10% in 2022), sales could reach approximately $600 million annually by 2025.
- Price decreases could moderate growth; however, volume expansion offsets potential price drops.
Key Market and Pricing Risks
- Patent expiration: No patent expiry until 2030, offering pricing stability.
- Regulatory changes: Favorable with continued indication expansion.
- Competition: Generics or biosimilars could reduce prices by 20-30%.
- Market penetration: Slower adoption due to clinician or payer hesitancy could limit sales growth.
Summary
Nexletol (NDC 31722-0934) maintains a stable pricing environment driven by current market demand, minimal competition, and ongoing approval for expanded indications. Prices are expected to rise modestly through 2027, with potential stabilization or decline if biosimilars or generics enter the market. Sales growth will hinge on adoption rates and reimbursement policies.
Key Takeaways
- Nexletol is positioned as an adjunct therapy for hypercholesterolemia with annual sales forecasted to surpass $600 million by 2025.
- Current monthly WAC for the drug ranges from $595 to $620.
- Price stability is expected through 2025, with potential declines if biosimilars or generics disrupt the market.
- Competition from PCSK9 inhibitors and other lipid-lowering drugs influences pricing strategy.
- Market growth depends heavily on clinician adoption and payer reimbursement policies.
FAQs
Q1. What factors most influence Nexletol’s future pricing?
Patent protection status, competition from generics, reimbursement policies, and market penetration levels.
Q2. How does Nexletol compare in price with PCSK9 inhibitors?
Nexletol’s monthly WAC is approximately $595–$620, whereas PCSK9 inhibitors like evolocumab can cost over $1,600 monthly, positioning Nexletol as a more affordable option.
Q3. What is the likelihood of generic entry impacting Nexletol’s prices?
Generic bempedoic acid is not yet available, with patent expiry expected around 2030. Entry before that is unlikely without patent challenges.
Q4. What are the key risks to sales growth?
Delayed adoption by physicians, restrictive reimbursement policies, or shifts in treatment guidelines favoring alternative drugs.
Q5. How might new lipid-lowering therapies affect Nexletol’s market?
New therapies with superior efficacy or lower costs could reduce Nexletol’s market share and exert downward pressure on its price.
References
- FDA. (2022). Nexletol (bempedoic acid) approval information. Retrieved from https://www.fda.gov/
- IQVIA. (2023). National Prescription Audit. US pharmaceutical sales data.
- Esperion. (2022). Nexletol product information.
- MarketWatch. (2022). Global cholesterol management drugs market report.
- CMS. (2023). Reimbursement policies for lipid-lowering medications.
