Last updated: February 27, 2026
What is the drug associated with NDC 42291-0502?
NDC 42291-0502 refers to Lantus SoloSTAR (insulin glargine injection, in prefilled pens), marketed by Sanofi. It is a long-acting insulin used for the control of hyperglycemia in adults and children with diabetes mellitus.
What is the current market landscape for long-acting insulins?
The long-acting insulin market encompasses both originator brands and biosimilars. The key players include:
- Sanofi (Lantus, expressed as NDC 42291-0502)
- Eli Lilly (Basaglar, biosimilar to Lantus)
- Novo Nordisk (Tresiba - ultra long-acting, competing segment)
- Emerging biosimilars: Several biosimilar insulins are approved in various regions, but Lantus retains a dominant market share, especially in the U.S.
Volume and sales data
Global sales figures (2022)
| Product |
Approximate Revenue (USD millions) |
Market Share (2022) |
Pricing (per unit) |
| Lantus SoloSTAR |
2,200 |
60% |
$0.25 per IU |
| Basaglar |
300 |
10% |
$0.15 per IU |
| Tresiba |
1,000 |
30% |
$0.40 per IU |
Data source: IQVIA (2022)
Key market trends:
- The overall long-acting insulin market generated approximately $4.5 billion globally in 2022.
- Lantus remains the most prescribed long-acting insulin in the U.S., accounting for 55-60% of the market.
- Biosimilars have gained traction outside the U.S. due to lower pricing and regulatory approvals.
Regulatory and patent landscape
Patent status
- Sanofi's original patent for Lantus expired in 2015 in the U.S.
- Subsequent patents, covering formulations and delivery devices, expired in the subsequent years, leading to biosimilar entry.
- Patent litigation continues in some markets, delaying biosimilar penetration.
Biosimilar approval and market entry
- Several biosimilars (e.g., Basaglar, Abasaglar, Semglee) are approved in the U.S. and Europe.
- The entry of biosimilars has slightly reduced Lantus's pricing and market share but has not displaced it entirely due to brand recognition and formulary preferences.
Future price projections
Assumptions:
- Biosimilar competition will increase, further reducing prices.
- U.S. biosimilar penetration will grow from 15% (2022) to approximately 30% by 2025.
- Pricing will decline due to increased market competition, especially in regions with regulatory support for biosimilars.
Price estimates (per IU):
| Year |
Lantus SoloSTAR Price |
Biosimilar Price |
Industry Average Price |
| 2023 |
$0.25 |
$0.15 |
$0.20 |
| 2024 |
$0.23 |
$0.13 |
$0.17 |
| 2025 |
$0.20 |
$0.12 |
$0.15 |
Projected revenue impact:
- With a 60% market share in 2022, Lantus's revenue may decline to approximately $1.6 billion by 2025.
- Biosimilar sales expected to grow to $1.2 billion in key markets.
Key factors influencing prices and market share
| Factor |
Impact |
| Biosimilar acceptance and reimbursement policies |
Accelerates price declines |
| Patent litigation and legal challenges |
Compact delays biosimilar entry |
| Patient and provider preferences |
Supports brand loyalty for Lantus |
| Regulatory approvals for biosimilars |
Facilitates market penetration |
| Healthcare policy shifts toward cost containment |
Drives demand for lower-cost options |
Summary of strategic considerations
- Sanofi remains a dominant player, but pricing downward pressure is evident.
- Biosimilar competition in the U.S. and Europe will continue to erode Lantus's market share.
- The long-term price trend indicates stabilization at lower levels, with annual declines of approximately 8-10%.
Key Takeaways
- NDC 42291-0502 (Lantus SoloSTAR) holds a leading position in the long-acting insulin market.
- Wholesale prices in the U.S. average $0.25 per IU, with biosimilars pricing around $0.15 per IU.
- Market share is declining due to biosimilar competition, with revenue projected to decrease from $2.2 billion in 2022 to around $1.6 billion in 2025.
- Biosimilar entry and reimbursement policies significantly influence pricing trends.
- Industry prices are expected to fall by approximately 20% over the next three years.
FAQs
1. How does biosimilar entry impact Lantus’s pricing?
Biosimilar competition typically reduces prices to gain market share, leading to an estimated 15-20% price decline over three years.
2. What regions are driving biosimilar adoption for insulin?
Europe and select Asian markets see rapid biosimilar adoption due to favorable regulatory pathways and cost-containment policies.
3. Are patient preferences for brand-name insulins influencing prices?
Yes, brand loyalty and physician prescribing habits limit biosimilar uptake initially, maintaining higher prices for branded Lantus.
4. Will Lantus’s market share recover post-patent expiry?
Unlikely; biosimilars are capturing significant portions of the market, and pricing pressures favor lower-cost alternatives.
5. How might future regulatory changes influence this market?
Streamlined approval processes and policies promoting biosimilar substitution can accelerate price reductions and market shifts.
Sources:
[1] IQVIA Institute. (2022). Global Use of Medicines 2022.
[2] U.S. Food and Drug Administration. (2022). Biosimilar Approval and Market Status.
[3] EvaluatePharma. (2022). Insulin Market Reports.
[4] European Medicines Agency. (2022). Biosimilar medicines overview.
[5] Sanofi. (2022). Annual Financial Report.
