Last updated: February 14, 2026
What is NDC 00641-6063?
NDC 00641-6063 is the National Drug Code for Insulin Glargine (U-100), a long-acting insulin used to improve blood sugar control in adults and children with diabetes mellitus. It is marketed under brand names such as Lantus by Sanofi.
Market Size and Volume
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The global insulin market totaled approximately USD 25.72 billion in 2022 [1].
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Insulin Glargine (U-100) accounts for roughly 70% of basal insulin sales, with estimated sales exceeding USD 15 billion annually globally [2].
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Use is concentrated in the U.S., where over 34 million Americans have diabetes, with 24 million diagnosed [3].
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Annual prescriptions for basal insulins, including insulins like Glargine, are estimated at around 150 million units globally [4].
Competitive Landscape
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Major competitors include Novo Nordisk's Tresiba (insulin degludec), Lyumjev (insulin lispro), and biosimilar versions of insulin Glargine approved in select markets.
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Patent expiration for original Lantus occurred in 2015 in the EU and 2019 in the U.S., leading to biosimilar entry.
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Biosimilar insulin Glargine products exist in Europe (e.g., Basaglar by Lilly), with limited U.S. approval as of 2022.
Regulatory Considerations
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The FDA approved biosimilar versions of insulin Glargine starting with Basaglar in 2015, with subsequent approvals expanding options.
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Regulatory pathways have become streamlined, increasing biosimilar market penetration.
Price Trends and Projections
Historical Pricing
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Brand-name Lantus: Average wholesale price (AWP) in the U.S. was approximately USD 250–USD 300 per vial (10 mL, 100 units/mL) in 2022.
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Biosimilars: Priced roughly 15%-20% below the brand, around USD 200–USD 250 per vial.
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Generic versions have pressured prices downward; however, prices still remain high compared to manufacturing costs.
Factors Influencing Price Trajectory
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Patent Expirations: The patent expiry of the original formulation fosters increased biosimilar competition, which usually drives prices downward over 3–5 years.
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Market Penetration: Biosimilar adoption is gradual; in the U.S., biosimilars accounted for approximately 20% of insulin prescriptions in 2022.
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Pricing Policies: Insurers and pharmacy benefit managers (PBMs) influence net prices; increased utilization of biosimilars could reduce net prices further.
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Innovation and New Formulations: Advances in insulin analogs with longer durations or concentrated formulations may shift demand and pricing dynamics.
Price Projection (Next 5 Years)
| Year |
Estimated Average Wholesale Price (USD) per 10 mL vial |
| 2022 |
250 – 300 |
| 2023 |
230 – 280 |
| 2024 |
210 – 260 |
| 2025 |
200 – 240 |
| 2026 |
190 – 220 |
Note: These estimates reflect continued biosimilar adoption, policy-driven price pressures, and generic entry.
Investment and R&D Outlook
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Market growth is driven by expanding diabetes prevalence, especially in developing regions.
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R&D efforts focus on ultra-long-acting insulins and insulin delivery systems, potentially impacting demand for traditional formulations like NDC 00641-6063.
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Biosimilar proliferation remains a key factor influencing price declines and market share redistribution.
Key Takeaways
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NDC 00641-6063 (insulin glargine U-100) remains a major component of the basal insulin market, valued at over USD 15 billion annually globally.
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Price erosion is ongoing, driven by biosimilar entry, patent expirations, and policy reforms.
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Wholesale prices are projected to decline modestly over the next five years, aligning with trends observed in biosimilar adoption.
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Market penetration of biosimilars in the U.S. remains limited but is expected to increase, further pressuring prices.
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Potential shifts include new long-acting insulin formulations and innovation in insulin delivery, which could impact market dynamics.
FAQs
1. How does biosimilar entry affect insulin prices?
Biosimilar entry typically reduces prices by 15%–20% initially, with further reductions possible as market competition increases.
2. What factors could accelerate price reductions?
Increased biosimilar adoption, policy reforms promoting biosilver use, and patent challenges.
3. Are there regional differences in insulin pricing?
Yes. U.S. prices are higher due to less regulation, while European countries have tighter price controls, leading to lower overall costs.
4. How significant is the impact of R&D on future prices?
R&D advancements may lead to premium-priced novel insulins, potentially offsetting declines in older formulations.
5. What is the outlook for biosimilar insulin market share?
Expected to reach 30–50% in the U.S. within five years, impacting price dynamics significantly.
References
[1] Grand View Research, "Insulin Market Size, Share & Trends," 2022.
[2] IQVIA, "Worldwide trends in insulin consumption," 2022.
[3] CDC, "National Diabetes Statistics Report," 2022.
[4] EvaluatePharma, "Insulin Market Trends," 2022.
Note: Precise pharmaceutical pricing and sales data are subject to market fluctuations and policy changes.
