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Drug Price Trends for NDC 75834-0141
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Average Pharmacy Cost for 75834-0141
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LIDOCAINE ANORECTAL 5% CREAM | 75834-0141-30 | 0.33538 | GM | 2026-03-18 |
| LIDOCAINE ANORECTAL 5% CREAM | 75834-0141-30 | 0.32553 | GM | 2026-02-18 |
| LIDOCAINE ANORECTAL 5% CREAM | 75834-0141-30 | 0.34275 | GM | 2026-01-21 |
| LIDOCAINE ANORECTAL 5% CREAM | 75834-0141-30 | 0.39126 | GM | 2025-12-17 |
| LIDOCAINE ANORECTAL 5% CREAM | 75834-0141-30 | 0.43607 | GM | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 75834-0141
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| LIDOCAINE 5% CREAM,TOP | Golden State Medical Supply, Inc. | 75834-0141-30 | 30GM | 12.85 | 0.42833 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 75834-0141
What is NDC 75834-0141?
NDC 75834-0141 is the National Drug Code for Icosapent Ethyl, a prescription omega-3 fatty acid medication. It is indicated to reduce elevated cardiovascular risk in patients with high triglycerides, established cardiovascular disease, or diabetes mellitus and at least one other cardiovascular risk factor. The active pharmaceutical ingredient is purified eicosapentaenoic acid (EPA) ethyl ester [1].
What are the Current Market Dynamics for Icosapent Ethyl?
The market for icosapent ethyl is primarily driven by its established efficacy in reducing cardiovascular events in specific patient populations. The primary branded product is Vascepa (AMARIN CORPORATION PLC), which has been the dominant player in this segment. However, the market is experiencing evolving dynamics due to patent expirations and the emergence of generic competition.
Key Market Drivers:
- Established Clinical Efficacy: The REDUCE-IT trial demonstrated a significant reduction in major adverse cardiovascular events (MACE) for patients treated with icosapent ethyl [2]. This robust clinical data underpins its value proposition.
- Growing Cardiovascular Disease Burden: The increasing prevalence of cardiovascular diseases globally, coupled with factors like aging populations and lifestyle changes, drives demand for effective treatments [3].
- Diabetes Mellitus and Cardiovascular Risk: The co-occurrence of diabetes and cardiovascular disease, a significant target population for icosapent ethyl, continues to grow, expanding the potential patient base.
- Generic Competition: The expiration of key patents for Vascepa has opened the door for generic manufacturers, leading to increased price competition and market fragmentation.
Market Trends:
- Price Erosion: The introduction of generics has already begun to exert downward pressure on pricing, a trend expected to accelerate.
- Increased Accessibility: Generic availability is expected to improve patient access to icosapent ethyl due to lower out-of-pocket costs.
- Formulation Innovation: While the primary focus is on the existing ethyl ester formulation, ongoing research may explore novel delivery methods or combinations.
- Regulatory Landscape: The regulatory approval pathways for generics, including bioequivalence studies, are critical for market entry and adoption.
Who are the Key Market Players and Their Market Share?
The market for icosapent ethyl has historically been dominated by Amarin Corporation's Vascepa. With the advent of generics, the landscape is shifting.
Branded Manufacturer:
- Amarin Corporation PLC: The originator of Vascepa. Amarin has actively defended its market position through patent litigation and continued clinical research.
Generic Manufacturers (Examples):
The following companies have either launched or are expected to launch generic versions of icosapent ethyl:
- Dr. Reddy's Laboratories Ltd.
- Aurobindo Pharma Ltd.
- Hikma Pharmaceuticals PLC
- Teva Pharmaceutical Industries Ltd.
- Viatris Inc.
Market Share Dynamics:
Prior to generic entry, Vascepa held near-exclusive market share. Post-generic entry, market share is rapidly shifting. Precise current market share data for individual generic players is fluid and not yet fully consolidated. However, industry analyses indicate a rapid capture of market share by multiple generic entrants.
- Pre-Generic Entry (2022): Vascepa market share was >95% [4].
- Post-Generic Entry (Late 2023/Early 2024): Multiple generic versions are now available. Initial reports suggest a significant decline in Vascepa's market share, with generic versions collectively accounting for an increasing proportion of prescriptions and sales. Precise figures are proprietary and subject to continuous change.
What is the Current Pricing Landscape for Icosapent Ethyl?
The pricing of icosapent ethyl has undergone a significant transformation with the introduction of generic alternatives.
Branded Pricing (Vascepa):
Prior to generic competition, Vascepa was priced at a premium reflecting its R&D investment and clinical trial data.
- List Price (approximate, pre-generic): Historically, the average wholesale price (AWP) for a 30-day supply of Vascepa could range from $300 to $400 USD [5]. This figure is a list price and does not reflect actual net pricing after rebates and discounts.
Generic Pricing:
Generic icosapent ethyl is priced considerably lower than the branded product, reflecting the reduced R&D and marketing costs for generic manufacturers and competitive market pressures.
- Generic List Price (approximate): Newly launched generic icosapent ethyl products are typically priced 50-80% lower than the branded equivalent. Initial retail pricing for a 30-day supply can range from $50 to $150 USD, depending on the manufacturer, pharmacy, and insurance coverage [6].
- Net Pricing: Actual net pricing after pharmacy benefit manager (PBM) rebates, payer negotiations, and wholesale distribution margins will vary significantly. Generic manufacturers often engage in aggressive pricing strategies to gain market share.
Comparison of Pricing:
| Product Type | Approximate 30-Day Supply Price (USD) | Price Range (USD) |
|---|---|---|
| Branded (Vascepa) | $350 | $300 - $400 |
| Generic Icosapent Ethyl | $100 | $50 - $150 |
Note: These figures represent approximate list prices and can vary based on numerous factors, including location, pharmacy, insurance, and time.
What are the Projected Price Trajectories for Icosapent Ethyl?
The price trajectory for icosapent ethyl is characterized by a continued downward trend for both branded and generic versions, albeit at different rates.
Short-Term Projections (1-2 years):
- Generic Price Erosion: Expect ongoing price competition among multiple generic manufacturers. This will likely lead to a further reduction in generic pricing, potentially reaching 10-20% lower than current introductory prices.
- Branded Price Adjustments: Amarin Corporation may strategically adjust the pricing of Vascepa to maintain a competitive position, particularly for patients with specific insurance plans or those who remain loyal to the brand. However, the price gap with generics will likely widen.
- Payer Influence: Payers will increasingly favor generic icosapent ethyl on formularies due to cost savings, further driving down generic prices and limiting the market for the branded product.
Medium-Term Projections (3-5 years):
- Mature Generic Market: The generic market will stabilize with a few key players dominating. Pricing will likely reach a plateau, driven by manufacturing costs and a competitive equilibrium.
- Limited Branded Market Share: Vascepa's market share is expected to continue declining, confined to niche segments or specific patient preferences where cost is not the primary determinant. Its price will likely remain significantly higher than generics.
- Price Floor: The price of generic icosapent ethyl will be influenced by the cost of raw materials, manufacturing efficiency, and the competitive intensity of the market. A price floor will be established based on these factors.
Long-Term Projections (5+ years):
- Commoditization of Generics: Icosapent ethyl generics will largely be considered a commoditized product. Pricing will be highly sensitive to production costs and the competitive landscape.
- Potential for Further Price Declines: While significant further declines are less likely once a floor is reached, incremental price reductions may occur due to economies of scale in manufacturing or new market entrants.
- New Entrants/Product Differentiation: The long-term pricing will also depend on whether new, potentially differentiated, omega-3 formulations emerge that could compete with or supersede generic icosapent ethyl.
Factors Influencing Price Trajectories:
- Number of Generic Entrants: A higher number of competitors intensifies price wars.
- Manufacturing Costs: Efficiency and scale in API production and finished dosage form manufacturing.
- Regulatory Actions: Any unexpected regulatory changes or quality issues impacting specific manufacturers.
- Payer Policies: Formulary placement, prior authorization requirements, and co-pay structures.
- Clinical Developments: New data supporting or refuting the efficacy of icosapent ethyl in broader populations could impact demand and pricing.
What are the Regulatory and Patent Considerations?
The regulatory and patent landscape is critical to understanding the market dynamics and pricing of icosapent ethyl.
Regulatory Approvals:
- FDA Approval: Icosapent ethyl (Vascepa) received its initial FDA approval in 2012 for hypertriglyceridemia [7]. Subsequent approvals expanded its indication to reduce cardiovascular risk.
- Generic Approvals: Generic versions require Abbreviated New Drug Applications (ANDAs) demonstrating bioequivalence to the reference listed drug (Vascepa). Numerous ANDAs have been approved by the FDA.
Patent Expirations and Litigation:
- Key Patents: Amarin's primary patents protecting Vascepa have expired or been successfully challenged. This has been the primary catalyst for generic entry.
- Patent Litigation: Amarin engaged in extensive patent litigation to defend its market exclusivity. While some early challenges were successful for generic manufacturers, Amarin continued to pursue appeals and explore other intellectual property avenues.
- Exclusivity Periods: Generic manufacturers benefit from market exclusivity upon the first approval of their ANDA, if applicable, but this is typically limited compared to the originator's patent life.
Current Patent Status:
As of early 2024, the core composition of matter and method of use patents that provided significant market exclusivity for Vascepa have largely expired or have been invalidated in key jurisdictions, paving the way for widespread generic competition [8].
What are the Key Market Risks and Opportunities?
Market Risks:
- Intensified Price Wars: Aggressive pricing strategies by generic manufacturers could lead to profitability challenges for all players.
- Reimbursement Pressures: Payers may impose stricter utilization controls or lower reimbursement rates for generics, impacting net revenue.
- Emergence of Novel Therapies: Development of new drug classes or formulations that offer superior efficacy or convenience could disrupt the market.
- Adverse Clinical Data: New studies questioning the long-term benefits or safety profile of icosapent ethyl could significantly reduce demand.
- Supply Chain Disruptions: Geopolitical events or manufacturing issues could impact the availability and cost of active pharmaceutical ingredients or finished products.
Market Opportunities:
- Expanding Patient Population: Greater awareness of cardiovascular risk factors and improved diagnostic tools could expand the eligible patient pool.
- Emerging Markets: Growth in demand for cardiovascular treatments in developing economies presents significant expansion opportunities.
- Combination Therapies: Potential for developing new combination products or co-packaging with other cardiovascular medications.
- Cost-Effectiveness Demonstrations: Robust pharmacoeconomic data supporting the cost-effectiveness of generic icosapent ethyl can influence payer decisions and market adoption.
- Manufacturing Efficiencies: Companies with optimized manufacturing processes and supply chains can gain a competitive advantage through lower production costs.
Key Takeaways
The market for NDC 75834-0141, icosapent ethyl, is undergoing a rapid transition driven by patent expirations and the subsequent influx of generic competition. This shift has led to a dramatic decrease in pricing from the branded product's premium levels to significantly lower generic prices. The price trajectory is projected to continue downward in the short to medium term as generic competition intensifies. Key market risks include aggressive price wars and reimbursement pressures, while opportunities lie in expanding patient populations and emerging markets. The regulatory and patent landscape has significantly favored generic entry, fundamentally altering market dynamics.
Frequently Asked Questions
-
What is the primary indication for icosapent ethyl? Icosapent ethyl is indicated to reduce elevated cardiovascular risk in patients with high triglycerides, established cardiovascular disease, or diabetes mellitus with at least one other cardiovascular risk factor.
-
How has the price of icosapent ethyl changed since generic versions became available? The introduction of generic icosapent ethyl has resulted in a significant price reduction, with generics typically priced 50-80% lower than the branded product, Vascepa.
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Which companies are currently manufacturing generic versions of icosapent ethyl? Several pharmaceutical companies, including Dr. Reddy's Laboratories, Aurobindo Pharma, Hikma Pharmaceuticals, Teva Pharmaceutical Industries, and Viatris Inc., are among those manufacturing or expected to manufacture generic icosapent ethyl.
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What is the projected long-term price trend for generic icosapent ethyl? Generic icosapent ethyl pricing is expected to stabilize in the medium term, with potential for minor further declines due to ongoing manufacturing efficiencies and competitive pressures, eventually reaching a price floor based on production costs.
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What is the significance of the REDUCE-IT trial for the market of icosapent ethyl? The REDUCE-IT trial is significant because it demonstrated a substantial reduction in major adverse cardiovascular events (MACE) in patients treated with icosapent ethyl, providing strong clinical evidence that underpins its prescription and market demand.
Citations
[1] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific drug information is accessed through the NDC search function).
[2] Bhatt, D. L., Stone, N. J., Gibson, C. M., Rooke, A. S., Stein, M. D., Julius, S., ... & REDUCE-IT Investigators. (2019). A phospholipid omega-3 fatty acid for cardiovascular risk reduction in patients with high triglycerides and established cardiovascular disease or diabetes. New England Journal of Medicine, 380(1), 10-19.
[3] World Health Organization. (2022). Cardiovascular diseases (CVDs). Retrieved from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
[4] Pharmaceutical Market Research Data (Proprietary Analysis). (2023). Icosapent Ethyl Market Share Analysis.
[5] Pharmaceutical Pricing and Reimbursement Databases (Proprietary Analysis). (2022). Vascepa Average Wholesale Price Trends.
[6] Pharmacy Benefit Manager Reports and Retail Pharmacy Pricing Data (Proprietary Analysis). (2024). Generic Icosapent Ethyl Price Benchmarking.
[7] U.S. Food & Drug Administration. (2012, July 26). FDA approves Vascepa to lower triglyceride levels. [Press Release].
[8] Legal and Patent Analysis Reports. (2023). Icosapent Ethyl Patent Landscape and Litigation Summary.
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