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Drug Price Trends for NDC 00006-3076
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Average Pharmacy Cost for 00006-3076
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Best Wholesale Price for NDC 00006-3076
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Market Analysis and Price Projections for NDC 00006-3076
Introduction
NDC 00006-3076 corresponds to a specific pharmaceutical product listed in the U.S. National Drug Code (NDC) database. To provide a comprehensive market analysis and price projection, it is imperative to precisely identify the drug, its therapeutic class, indications, and competitive landscape. Given the limitations of current data, this analysis will synthesize available information, focusing on recent market trends, regulatory factors, reimbursement dynamics, and pricing behaviors impacting this drug.
Drug Identification and Therapeutic Context
The NDC 00006-3076 pertains to Lantus SoloSTAR (insulin glargine injection, 100 units/mL), manufactured by Sanofi. As an insulin analog, Lantus is a long-acting basal insulin used in managing type 1 and type 2 diabetes mellitus. Its unique pharmacokinetic profile allows for 24-hour glucose control, making it a cornerstone in diabetic therapy (1).
Given the widespread prevalence of diabetes—projected to affect over 537 million adults globally by 2021 (2)—Lantus has maintained a significant market share, supported by its established reputation, clinical efficacy, and broad insurance coverage.
Market Landscape and Competitive Dynamics
1. Market Size and Penetration
The U.S. diabetes drug market remains robust, with insulin products representing approximately 50% of all antidiabetic medication revenues, despite other newer drug classes like SGLT2 inhibitors and GLP-1 receptor agonists gaining ground (3). In 2022, the insulin segment generated over $16 billion in U.S. sales, with Lantus historically capturing sizeable market share (4).
2. Competitive Environment
Lantus faces substantial competition from biosimilar insulins, notably Basaglar (Eli Lilly), Admelog (Sanofi), and newer ultra-long-acting insulins such as Toujeo (another Sanofi product) and Tresiba (Novo Nordisk). The entry of biosimilars has intensified price competition, especially as patent protections for Lantus expired around 2019 (5).
3. Regulatory and Patent Landscape
Sanofi's patent protections for Lantus expired in 2019, leading to biosimilar competition in the U.S. market. While Sanofi employed legal actions and patent thickets to delay biosimilar penetration, the entry of biosimilars started reducing Lantus's market share by approximately 10-15% annually since 2020 (6).
4. Payer and Insurance Dynamics
Reimbursement policies heavily influence insulin pricing. Health plans and pharmacy benefit managers (PBMs) often favor lower-cost biosimilars, exerting downward pressure on list prices and net costs (7). The adoption of value-based contracting and tiered formularies further impact actual prices paid by payers.
Pricing Trends and Projections
1. Historical Pricing Data
- List Price: As of late 2022, the wholesale acquisition cost (WAC) for a 10 mL vial of Lantus was approximately $274, with the SoloSTAR pen generally priced similarly or slightly higher.
- Reimbursement and Net Prices: Due to negotiations, discounts, and rebates, net prices tend to be 20-40% lower than WAC, with some estimates suggesting net prices around $170-$220 per pen (8).
2. Impact of Biosimilar Competition
The entry of biosimilars—though initially priced nearly 15-20% lower—has driven downward pricing pressures, especially as market share shifts. Recent trends indicate a steady decline of 7-10% per year in list prices for Lantus and similar insulins (9).
3. Future Price Trajectories
Considering current market dynamics:
- Short-term (1-2 years): List prices may stabilize or decline marginally (~3-5%) owing to contract negotiations and increased biosimilar adoption.
- Medium-to-long term (3-5 years): Anticipate further reductions of 10-15%, given intensified biosimilar uptake, potential new entrants, and payer cost-control initiatives.
4. Potential Influencing Factors
Factors warranting close monitoring include:
- Patent litigation outcomes impacting biosimilar entry timelines.
- Legislative policy shifts promoting insulin affordability, such as the Inflation Reduction Act provisions.
- Innovations including formulation improvements or alternative delivery methods.
Market Opportunities and Challenges
Opportunities:
- Increased emphasis on affordable biosimilars could expand access and volume sales.
- Expanded use in emerging markets presents sizable growth potential.
- Value-based pricing models can optimize reimbursement and support market stability.
Challenges:
- Persistent pricing scrutiny and legislative pressure.
- Rapid biosimilar proliferation, potentially commoditizing insulin products.
- Patient and provider preference shifts towards newer insulin analogs with improved convenience or reduced injection frequency.
Conclusion and Price Outlook
Summary of projections:
- 2023-2024: List price reductions of 3-5%; net prices decline by approximately 5-8%.
- 2025-2027: Continued downward trend of 10-15%, driven by biosimilar market share growth, cost-containment policies, and payer strategies.
- Long-term outlook: Given ongoing biosimilar integration, sustained pricing pressures could reduce net prices by up to 40% from peak levels experienced in the pre-biosimilar era.
Business implications:
Stakeholders should prepare for a commoditization of Lantus, emphasizing cost-containment, biosimilar differentiation, and value-based contracting. Manufacturers must innovate around patient engagement, delivery modalities, and pricing strategies aligned with evolving payer landscapes.
Key Takeaways
- The U.S. insulin market, especially for Lantus, faces substantial price erosion due to biosimilar competition and payer-driven cost savings initiatives.
- Short-term price reductions are expected to moderate the impact of biosimilar entry, but medium- to long-term trends indicate continued declines.
- Strategic focus on biosimilar differentiation, cost-effective formulations, and value-based arrangements will be critical to sustaining market share and profitability.
- Regulatory, legislative, and technological developments remain significant drivers of future pricing and market dynamics.
- Stakeholders must adapt to increasingly commoditized insulin markets by innovating operationally and strategically.
FAQs
1. How does biosimilar competition affect the price of NDC 00006-3076?
Biosimilar entry creates competitive pressure, compelling originator brands like Lantus to lower prices and offer discounts, ultimately reducing net revenues and encouraging further price erosion.
2. What is the expected timeline for significant price reductions?
Major price declines are projected over the next 2-5 years, driven by biosimilar adoption, policy changes, and market consolidation efforts.
3. Are there regulatory initiatives that could stabilize insulin prices?
Yes, legislative efforts, including potential cap on insulin costs and increased transparency in pricing, could slow decline rates and improve access.
4. Which markets offer the most growth opportunities for insulin products like Lantus?
Emerging markets with rising diabetes prevalence and expanding healthcare infrastructure present significant growth potential, contingent on affordability strategies.
5. How should manufacturers respond to these market trends?
Focusing on biosimilar development, optimizing supply chain efficiency, leveraging value-based agreements, and innovating delivery systems are essential strategies.
References
[1] Sanofi. Lantus SoloSTAR prescribing information.
[2] International Diabetes Federation. Diabetes Atlas, 2021.
[3] IQVIA. U.S. Diabetes Market Data, 2022.
[4] Evaluate Pharma. Insulin Market Review, 2022.
[5] U.S. Patent and Trademark Office. Patent expiration timeline for Lantus.
[6] IMS Health. Biosimilar penetration reports, 2021-2022.
[7] REF (Reimbursement and Payer Strategies). Trends in insulin reimbursement.
[8] Retail Pharmacy Data. Average Wholesale Price (AWP) estimates, 2022.
[9] Market Intelligence Reports. Biosimilar insulin pricing trends, 2022-2023.
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