Drug Price Trends for NDC 51407-0646

Average Pharmacy Cost for 51407-0646

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 51407-0646

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
BISOPROLOL FUMARATE 10MG TAB	Golden State Medical Supply, Inc.	51407-0646-01	100	14.75	0.14750	2023-06-15 - 2028-06-14	FSS
BISOPROLOL FUMARATE 10MG TAB	Golden State Medical Supply, Inc.	51407-0646-30	30	4.43	0.14767	2023-06-15 - 2028-06-14	FSS

Nexletol (Bempedoic Acid) Market Analysis and Price Projections

Last updated: February 18, 2026

Nexletol, the brand name for bempedoic acid, is a cholesterol-lowering medication approved for adults with established atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of LDL-C. This analysis examines the current market landscape, competitive environment, and projects future pricing trends for bempedoic acid based on patent exclusivity, market penetration, and reimbursement policies.

What is the Current Market Penetration of Bempedoic Acid?

Bempedoic acid (Nexletol) was approved by the U.S. Food and Drug Administration (FDA) in February 2020. Its market penetration is influenced by its efficacy in reducing LDL cholesterol, its safety profile, and its position relative to existing lipid-lowering therapies.

• Target Population: The drug is indicated for patients with established atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who have not achieved sufficient LDL-C reduction with maximally tolerated statin therapy, or for whom statins are contraindicated. This represents a significant patient pool.
• Efficacy: Clinical trials, such as the CLEAR Outcomes trial, demonstrated that bempedoic acid reduced the risk of major adverse cardiovascular events (MACE) by 13% compared to placebo in patients with high cardiovascular risk and statin intolerance or contraindication [1]. This finding is crucial for its adoption beyond just LDL-C lowering.
• Market Share: As of the latest available data, Nexletol has secured a modest but growing share of the dyslipidemia market. While specific market share figures fluctuate and are proprietary, industry reports indicate a gradual increase in prescription volumes since its launch. Estimates suggest that by early 2024, Nexletol held a low single-digit percentage of the overall non-statin LDL-C lowering market [2].
• Competition: The dyslipidemia market is highly competitive. Nexletol competes with established statins (e.g., atorvastatin, rosuvastatin), ezetimibe, PCSK9 inhibitors (e.g., evolocumab, alirocumab), and bempedoic acid/ezetimibe combination therapy (Nexlizet). The latter, Nexlizet (bempedoic acid and ezetimibe), launched in June 2020, offers a dual mechanism of action and is often prescribed to patients needing further LDL-C reduction [3].

What is the Patent Landscape for Bempedoic Acid?

The patent landscape is a critical determinant of pricing and market exclusivity for Nexletol. Patents protect the active pharmaceutical ingredient (API), manufacturing processes, and specific uses of the drug.

• Composition of Matter Patents: The primary patents covering bempedoic acid as a novel chemical entity are expected to expire in the coming years. The earliest foundational patents for bempedoic acid are reported to have expiration dates around 2031-2032 [4].
• Method of Use Patents: Additional patents may cover specific therapeutic indications, such as the use of bempedoic acid for cardiovascular risk reduction. The CLEAR Outcomes trial data supporting MACE reduction could be linked to patents protecting this specific use, potentially extending market exclusivity beyond the composition of matter patents.
• Exclusivity Periods: U.S. regulatory exclusivities (e.g., New Chemical Entity - NCE exclusivity) also play a role. The NCE exclusivity for bempedoic acid is typically five years from the date of approval, which would extend to February 2025 [5]. This means no generic versions of bempedoic acid can be approved for at least this period, regardless of patent expiration.
• Data Exclusivity: The significant clinical trial data, particularly the CLEAR Outcomes trial, can confer its own form of market protection. Regulatory agencies often grant data exclusivity periods based on the submission of new clinical trial data demonstrating significant new benefits.
• Patent Litigation: As patent expiry approaches, litigation between the innovator company (Esperion Therapeutics) and potential generic manufacturers is common. This can involve challenges to patent validity or alleged infringement. The outcome of such litigation can significantly alter the timeline for generic entry. As of early 2024, no major patent litigation actions have resulted in an imminent generic threat for bempedoic acid's core patents.

What are the Current Pricing and Reimbursement Dynamics?

The pricing and reimbursement of Nexletol are influenced by its clinical value proposition, competitor pricing, payer policies, and the U.S. healthcare system’s cost-containment measures.

• List Price: The Wholesale Acquisition Cost (WAC) for Nexletol (180 mg tablet) is approximately \$475 for a 30-day supply [6]. This list price does not reflect actual net prices, which are reduced by rebates and discounts negotiated with payers.
• Net Price: Actual net prices are substantially lower than the WAC. Through payer negotiations, net prices can range from 30% to 50% below the WAC, depending on the payer’s formulary and volume commitments. This puts the effective price in the range of \$237 to \$332 per month.
• Reimbursement Status: Nexletol is covered by most major commercial health insurance plans. However, coverage often involves prior authorization requirements, step-therapy protocols (requiring patients to try lower-cost alternatives like statins first), and co-insurance or co-pay obligations for patients.
• Medicare and Medicaid: Coverage under Medicare Part D and Medicaid programs varies by state and specific plan formulary. Similar to commercial plans, prior authorization and step-therapy are common.
• Value-Based Pricing Considerations: The CLEAR Outcomes trial results, demonstrating a reduction in cardiovascular events, provide a strong basis for value-based arguments to payers. Demonstrating a reduction in costly MACE events can justify a higher price point by offsetting downstream healthcare expenditures.
• Payer Restrictions: Payers often restrict Nexletol use to specific patient populations that align with its FDA-approved indications and demonstrate a clear need beyond first-line therapies. This includes patients with statin intolerance or those who have not met LDL-C goals despite aggressive statin therapy.

What are the Projected Future Market Trends?

Future market trends for bempedoic acid will be shaped by patent expiry, the introduction of generics, evolving clinical guidelines, and the performance of combination therapies.

• Increased Competition Post-Patent Expiry: Upon patent expiry and the loss of NCE exclusivity, generic versions of bempedoic acid are expected to enter the market. This will lead to significant price erosion, similar to trends observed with other branded generics. Generic competition typically drives down prices by 50% to 90% within two years of market entry [7].
• Impact of Generics on Net Prices: The introduction of generics will exert downward pressure on both list and net prices for bempedoic acid. The innovator product may retain some market share due to brand loyalty or payer contracts, but the vast majority of volume will likely shift to lower-cost generic alternatives.
• Growth of Combination Therapies: The bempedoic acid and ezetimibe combination (Nexlizet) is likely to see continued growth, especially if it can be positioned effectively by payers as a cost-effective alternative to injectables like PCSK9 inhibitors for certain patient segments.
• Evolving Clinical Guidelines: Updates to clinical guidelines from organizations like the American College of Cardiology (ACC) and the American Heart Association (AHA) will influence prescribing patterns. If guidelines further endorse bempedoic acid for specific indications or patient groups, market demand could increase, potentially offsetting some of the price erosion from generic competition.
• Market Size Projections: The global dyslipidemia drug market is projected to grow, driven by an aging population, rising prevalence of cardiovascular disease, and increased awareness of lipid management. Bempedoic acid, in both branded and generic forms, is expected to capture a portion of this growth. Market research reports project the non-statin LDL-C lowering market to reach \$15-20 billion by 2028, with bempedoic acid and its generics contributing a significant share within the oral segment [8].
• Geographic Expansion: While the U.S. is the primary market currently, opportunities for bempedoic acid exist in other developed markets in Europe and Asia, contingent on regulatory approvals and local reimbursement policies.

What are the Price Projections for Bempedoic Acid?

Price projections for bempedoic acid are highly dependent on the timing of generic entry and the competitive intensity post-exclusivity.

• Pre-Generic Entry (2024-2028): During this period of patent exclusivity and NCE protection, the net price for Nexletol is expected to remain relatively stable, with modest annual increases (2-5%) driven by inflation and payer negotiations. Net prices are projected to stay within the \$230-350 per month range for the branded product.
• Post-Generic Entry (2030 onwards): Following the expiration of key patents and loss of exclusivity, a significant decline in prices is anticipated.
  • Year 1 Post-Generic Entry: Net prices for branded Nexletol are likely to decrease by 30-50% as generics gain traction. Generic bempedoic acid will likely be priced at 60-80% below the original WAC, potentially reaching net prices of \$50-100 per month.
  • Year 2-3 Post-Generic Entry: Further price erosion will occur as multiple generic manufacturers enter the market. Net prices for generics could fall to \$30-70 per month. The branded product might be discontinued or maintain a niche presence at a significantly discounted price.
• Combination Therapy Pricing: The bempedoic acid/ezetimibe combination (Nexlizet) will face similar pricing dynamics. Its price will likely be higher than monotherapy bempedoic acid but will also be subject to significant downward pressure from generic competition for both components once patents expire.
• Factors Influencing Projections:
  • Patent Litigation Outcomes: Earlier-than-expected patent invalidation or successful challenges could accelerate generic entry and price declines.
  • Payer Behavior: Payer formulary placement and prior authorization policies will continue to influence access and net prices, even with generics available.
  • Clinical Utility of Generics: The adoption rate of generic bempedoic acid will depend on physician and patient trust in the bioequivalence and efficacy of generic products.
  • Emergence of Novel Therapies: The development of new classes of lipid-lowering drugs could shift market dynamics and impact the long-term pricing power of bempedoic acid and its generics.

Table 1: Projected Net Monthly Price Range for Bempedoic Acid (USD)

Period	Branded (Nexletol)	Generic Bempedoic Acid
2024-2028 (Pre-Generic)	\$230 - \$350	N/A
2030 (Year 1 Post-Generic)	\$120 - \$200	\$50 - \$100
2031-2032 (Year 2-3 Post-Generic)	\$80 - \$150	\$30 - \$70

Note: These are projected net price ranges and exclude the impact of potential new indications or significant shifts in the competitive landscape.

Key Takeaways

• Bempedoic acid (Nexletol) has secured a growing, albeit modest, market share in the competitive dyslipidemia market, supported by its demonstrated cardiovascular risk reduction benefits.
• Primary composition of matter patents are set to expire around 2031-2032, with U.S. NCE exclusivity extending to February 2025.
• Current net prices for Nexletol are approximately \$230-350 per month, subject to payer negotiations and formulary restrictions.
• Significant price erosion is projected post-generic entry, with generic bempedoic acid potentially priced at \$30-70 per month within two to three years of market launch.
• The CLEAR Outcomes trial data is a key asset for value-based discussions with payers, potentially sustaining some premium for the branded product or enabling favorable formulary placement for generics.

Frequently Asked Questions

• When is the earliest a generic version of Nexletol could become available in the U.S.? Generic entry is anticipated following the expiration of key composition of matter patents around 2031-2032, assuming no successful patent challenges that accelerate this timeline. U.S. New Chemical Entity exclusivity expires in February 2025, which is a prerequisite for generic approval.

• What is the significance of the CLEAR Outcomes trial for Nexletol's market position and pricing? The CLEAR Outcomes trial demonstrated that bempedoic acid reduces major adverse cardiovascular events (MACE) by 13%. This pivotal data strengthens the drug's value proposition for payers, justifying its use beyond simple LDL-C lowering and supporting its position in value-based pricing negotiations.

• How will the introduction of generic bempedoic acid impact the pricing of other LDL-lowering therapies, such as PCSK9 inhibitors? The price reduction of bempedoic acid generics may make them a more accessible alternative to higher-cost injectables like PCSK9 inhibitors for certain patient populations. This could lead to PCSK9 inhibitors being reserved for patients who do not respond to or tolerate oral therapies, potentially influencing their market share and pricing power.

• What are the primary challenges Nexletol faces in increasing its market penetration? Challenges include intense competition from established statins and ezetimibe, the high cost of newer therapies relative to generics, payer restrictions such as prior authorization and step-therapy, and the need for physicians to be educated on its specific place in therapy, particularly in the context of statin intolerance or contraindication.

• Will the bempedoic acid and ezetimibe combination (Nexlizet) face similar patent expirations and generic competition? Yes, Nexlizet is a fixed-dose combination of bempedoic acid and ezetimibe. Its market exclusivity will be governed by the patent and exclusivity periods of both active pharmaceutical ingredients. Generic versions of the combination therapy are expected to emerge after the relevant patents for both components expire.