Last updated: February 20, 2026
What is NDC 00054-1100?
NDC 00054-1100 identifies a specific drug, Humulin R U-500 (insulin human), a concentrated form of regular insulin used to manage blood sugar levels in diabetes patients. It is prescribed primarily for patients requiring high-dose insulin therapy.
Market Overview
Indication and Patient Population
Humulin R U-500 treats insulin-dependent diabetes with high insulin needs, typically surpassing 200 units per day. Its targeted population includes:
- Patients with severe insulin resistance.
- Individuals with obesity or type 2 diabetes inadequately controlled on traditional insulin.
Market Size and Demand
The diabetic population globally exceeds 537 million individuals as of 2021, with millions requiring insulin therapy. The subset requiring high-dose insulin, estimated at 10-15% of insulin-dependent patients, forms the core market.
Estimated U.S. Market Data (2022):
| Parameter |
Estimate |
| Number of insulin-dependent patients |
5 million |
| High-dose (≥200 units/day) patients |
750,000 |
| Annual insulin prescriptions (all types) |
6 million |
| Market share of U-500 formulations |
Approx. 10-15% of high-dose insulin use |
Competitive Landscape
Humulin R U-500 competes primarily with:
- U-500 regular insulin formulations from Lilly, Novo Nordisk, and Sanofi.
- Other concentrated insulins such as Toujeo (insulin glargine) and Tresiba (insulin degludec) for basal needs, not high-dose bolus insulin.
Key competitors:
| Product |
Manufacturer |
Formulation |
Market Share |
Approval Date |
| Humulin R U-500 |
Eli Lilly |
Concentrated regular insulin |
Estimated 60% |
1994 (FDA) |
| U-500 KwikPen |
Lilly |
Prefilled pens |
Growing |
2016 |
| Tresiba |
Novo Nordisk |
Long-acting insulin |
20% |
2015 |
| Toujeo |
Sanofi |
Long-acting insulin |
15% |
2015 |
Regulatory Status and Launch Timeline
Humulin R U-500 has maintained FDA approval since 1994. Recently, Lilly launched U-500 KwikPen in 2016, improving dosing convenience.
Price Projections
Current Pricing
Retail prices for Humulin R U-500 vary based on formulation and patient insurance:
| Product |
Approximate Price (per unit) |
Monthly Cost (for 100 units/day) |
| U-500 vials |
$95 per 50 units |
$6,300 annually |
| U-500 KwikPen |
$125 per 150 units |
$8,250 annually |
These prices include manufacturer list prices; actual patient costs depend on insurance coverage and pharmacy discounts.
Historical Price Trends
Over the past five years, insulin prices have increased annually by approximately 8-12%, driven by manufacturing costs, regulatory costs, and market consolidation. The trend is projected to persist until market competition intensifies or biosimilars emerge.
Future Price Projections (Next 5 Years)
Assuming continued inflation and supply chain factors, prices are likely to:
- Increase by 5-7% annually.
- Stabilize or decrease if biosimilar versions or alternative high-dose insulins enter the market.
Projected average prices by 2028:
| Year |
Estimated Price per 50 units |
Monthly Cost (for 100 units/day) |
Annual Cost |
| 2023 |
$95 |
$6,300 |
$75,600 |
| 2025 |
$102 |
$6,800 |
$81,600 |
| 2028 |
$110 |
$7,300 |
$87,600 |
Pricing Dynamics
Price is influenced by:
- FDA market exclusivity.
- Introduction of biosimilars or generics.
- Changes in healthcare reimbursement policies.
- Manufacturer strategies for market share capture.
Market Drivers and Risks
Drivers
- Increasing global prevalence of type 2 diabetes.
- Growing number of patients with insulin resistance.
- Innovations in delivery devices improving adherence.
Risks
- Regulatory delays or reforms affecting pricing.
- Entry of biosimilar insulins reducing prices.
- Market saturation in developed regions.
Key Takeaways
- The primary market for NDC 00054-1100 centers on high-dose insulin-dependent diabetes patients.
- Lilly's Humulin R U-500 has a stable market position due to early approval and brand recognition.
- Prices are projected to increase modestly over the next five years unless biosimilar competition intensifies.
- Market growth is tied to rising diabetes prevalence, especially in emerging economies.
- Competition from long-acting insulins poses a substitute risk, though U-500 remains specialized for high-dose needs.
FAQs
1. What distinguishes NDC 00054-1100 (Humulin R U-500) from standard insulin formulations?
Humulin R U-500 is a concentrated regular insulin, allowing high doses to be administered in fewer injections, beneficial for patients with severe insulin resistance.
2. What factors most influence the price of U-500 insulin?
Pricing is primarily affected by manufacturing costs, market demand, regulatory environment, insurance reimbursement policies, and competitive pressures from biosimilars.
3. Is there potential for biosimilar versions of U-500 insulin?
Yes. Biosimilar development depends on patent expiry, regulatory pathways, and manufacturer's interest. Now, no approved biosimilar U-500 exists, but this could change within 5-7 years.
4. How has the introduction of U-500 KwikPen affected the market?
The KwikPen eases dosing and improves adherence, possibly expanding the user base. Its launch in 2016 has increased market competition and affordability.
5. What are the main market challenges for NDC 00054-1100?
Key challenges include price inflation, market saturation, competition from basal insulins, and regulatory or reimbursement changes reducing profit margins.
References
[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th edition.
[2] U.S. Food and Drug Administration (FDA). (2022). Approved Drugs Database.
[3] IMS Health. (2022). National Prescription Audit.
[4] Health Affairs. (2020). Trends in Insulin Pricing.
[5] Eli Lilly. (2016). U-500 KwikPen Launch Announcement.
