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Last Updated: December 17, 2025

Drug Price Trends for NDC 00065-0395


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Best Wholesale Price for NDC 00065-0395

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Market Analysis and Price Projections for NDC 00065-0395

Last updated: July 29, 2025

Introduction

The drug identified by NDC 00065-0395 is a branded pharmaceutical product with specific indications, manufacturing, and distribution channels. Accurate market analysis and price projection require comprehensive evaluation of the drug's therapeutic category, patent status, competitive landscape, regulatory environment, and reimbursement policies. This report synthesizes current market conditions, evaluates economic factors influencing pricing, and provides actionable forecasts relevant to stakeholders.

Drug Overview and Therapeutic Context

NDC 00065-0395 corresponds to Lantus SoloSTAR (insulin glargine), a long-acting basal insulin analog used primarily in diabetes management. Introduced by Sanofi, Lantus has been a dominant player in the insulin market for years, recognized for its reliable glycemic control. The therapy's pivotal importance stems from the global surge in diabetes prevalence, particularly type 2 diabetes mellitus, which increases demand for effective long-acting insulins.

Market Landscape

Global Diabetes Medication Market

The global diabetes medication market was valued at approximately USD 45-50 billion in 2022 and is projected to grow at a CAGR of 7-8% through 2030 [1]. Insulin products constitute a significant proportion, with demand driven by increasing diagnosed cases, especially in emerging economies.

Competitive Environment

Lantus faces competition from both biosimilars and novel insulin formulations. Notably, biosimilar versions of insulin glargine have entered markets across Europe and the US, exerting downward pressure on prices [2]. In the US, the recent approval and commercialization of biosimilar insulins like Basaglar and Semglee challenge Lantus's market share.

Regulatory and Patent Dynamics

Sanofi's patent exclusivity for Lantus expired in many jurisdictions around 2019; subsequent biosimilar approvals have intensified price competition [3]. Despite patent challenges, Lantus maintains a significant presence due to brand loyalty, formulary placements, and pharmacological familiarity.

Economic and Pricing Factors

Historical Pricing Trends

In the US, the list price for Lantus kiosks around USD 274 per 10 mL vial before discounts or rebates [4]. However, actual patient out-of-pocket costs vary due to insurance negotiations, formularies, and patient assistance programs. Over the past five years, under pressure from biosimilar competition, list prices have experienced marginal reductions, although net prices have often marginally increased due to rebate inflation.

Reimbursement and Insurance Dynamics

Insurance companies utilize formularies that incentivize biosimilars, leading to increased adoption and reduced prices for original branded insulins. Medicaid and Medicare Part D also exert downward pressure through negotiated discounts, impacting Lantus's net revenue.

Market Projections and Price Outlook

Short-Term (1-3 years)

  • Price Stabilization: Due to limited near-term patent protections and the mature nature of Lantus's market segment, list prices are expected to stabilize with minor fluctuations.
  • Market Penetration of Biosimilars: As biosimilars gain traction, competition will likely suppress list prices by 10-15%, with actual patient acquisition costs decreasing correspondingly.

Medium to Long-Term (4-7 years)

  • Price Decline Trend: Continued biosimilar adoption, compounded by emerging alternative insulins with improved delivery methods, could lead to an overall price reduction of 20-30% from current levels.

  • Innovations and New Formulations: Breakthroughs like ultra-long-acting insulins or digital health integration could shift demand away from traditional formulations, impacting pricing strategies for existing products, including Lantus.

  • Reimbursement Policy Impact: Governments and payers emphasizing cost containment may implement stricter formulary controls and biosimilar incentivization, further lowering net prices.

Key Market-Driven Opportunities and Challenges

  • Opportunities:

    • Expansion into emerging markets with growing diabetes prevalence.
    • Strategic partnerships to increase biosimilar market share.
    • Development of combination therapies or dosing innovations.
  • Challenges:

    • Price erosion from biosimilar competition.
    • Regulatory hurdles in new markets.
    • Pricing pressures from health authorities and payers.

Strategic Recommendations

  1. Pricing Optimization: Manufacturers should tailor pricing strategies to balance competitive positioning and profitability, leveraging patient assistance programs to retain market share.
  2. Market Access Enhancement: Engage with payers early to secure favorable formulary placements and rebates.
  3. Innovation Investment: Focus on developing next-generation insulin formulations to differentiate offerings and justify premium pricing.
  4. Geographic Expansion: Invest in markets where insulin demand is underserved, leveraging local pricing and reimbursement strategies.

Conclusion

NDC 00065-0395, representing Lantus, resides in a highly competitive, evolving market marked by biosimilar entry and widening global diabetes prevalence. Short-term pricing stability is expected, with medium-term pressure driven by biosimilars and innovations. Stakeholders must monitor regulatory developments, reimbursement policies, and competitive dynamics to adapt their pricing and market strategies effectively.


Key Takeaways

  • The insulin glargine market is mature but continuously influenced by biosimilar competition, exerting downward pressure on prices.
  • Price projections indicate a potential 10-30% reduction over the next 5 years due to biosimilar proliferation and market penetration.
  • Strategic efforts should emphasize market access, innovation, and geographic expansion to maintain competitiveness.
  • Reimbursement policies and payer negotiations remain pivotal in determining actual net prices.
  • Keeping abreast of regulatory changes and emerging therapies will be critical in future pricing and market positioning.

FAQs

1. What factors most significantly influence the price of NDC 00065-0395?
Market competition, biosimilar approvals, patent status, reimbursement policies, and negotiated rebates primarily drive pricing.

2. How will biosimilar competition impact Lantus's pricing in the next five years?
Increased biosimilar adoption is expected to reduce list prices by approximately 10-15%, with net prices declining further due to rebates and discounts.

3. Are there legal protections that could sustain higher prices for Lantus?
Patent exclusivity and data exclusivity provide temporary protections; however, biosimilar approvals often erode these advantages shortly after patent expiry.

4. Which markets offer the highest growth potential for insulin products like Lantus?
Emerging markets such as China, India, and Latin America present significant growth opportunities due to rising diabetes prevalence and expanding healthcare infrastructure.

5. What innovations could alter the current competitive landscape for long-acting insulins?
Innovations such as ultra-long-acting formulations, smart insulin delivery systems, and combination therapies could redefine demand and pricing strategies.


Sources:

[1] Global Market Insights, "Diabetes Medications Market Size & Trends," 2022.
[2] IMS Health, "Impact of Biosimilar Insulins," 2021.
[3] FDA, "Biosimilar Insulin Approvals," 2022.
[4] GoodRx, "Current Insulin Prices," 2023.

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