Last updated: March 2, 2026
What is the Drug Corresponding to NDC 00002-8400?
The National Drug Code (NDC) 00002-8400 refers to Humulin R U-500 (insulin human injection, U-500), manufactured by Eli Lilly and Company. It is a concentrated insulin used to manage blood glucose in patients with severe insulin resistance.
Market Overview
Indication and Usage
Humulin R U-500 is prescribed for patients requiring high doses of insulin, often in cases of severe insulin resistance caused by obesity, type 2 diabetes, or other metabolic conditions. Its concentrated formulation reduces injection volume, improving adherence for patients with large insulin requirements.
Market Size and Drivers
The global insulin market was valued at approximately $23 billion in 2022 and is expected to reach $30 billion by 2027, with a compound annual growth rate (CAGR) of 5.2%.[1] U-500 insulin accounts for about 10% of insulin prescriptions in the United States, primarily driven by:
- Growing prevalence of type 2 diabetes
- Increasing recognition of insulin resistance
- Off-label use for atypical diabetes management
Competitive Landscape
Humulin R U-500 faces competition from other concentrated insulins like:
- Toujeo U-300 (insulin glargine) by Sanofi
- Tresiba U-200 (insulin degludec) by Novo Nordisk
- Insulin regular (U-100 and U-500 formulations) from multiple manufacturers
While U-500 formulations are less common than U-100 insulins, their niche remaining is patients with high insulin demand needing reduced injection frequency.
Price Analysis
Historical Pricing Data
| Year |
AWP Price per 10 mL Vial |
Wholesale Acquisition Cost (WAC) |
Estimated Retail Price |
| 2020 |
$600 |
$560 |
$650 |
| 2021 |
$620 |
$580 |
$680 |
| 2022 |
$640 |
$600 |
$700 |
Note: These prices are approximate and can vary by pharmacy and health insurer.
Pricing Trends and Factors
- Price increases have averaged 3-4% annually, aligning with inflation and manufacturing costs.
- Rebate programs and insurance negotiations reduce net prices for payers.
- The U.S. Inflation Reduction Act and price transparency initiatives could influence future pricing dynamics.
Future Price Projections (2023-2027)
| Year |
Projected WAC Price per 10 mL Vial |
Assumptions |
| 2023 |
$620 |
Moderate inflation, competitive pressures remain stable |
| 2024 |
$640 |
Slight price increases, potential policy impacts |
| 2025 |
$660 |
Market consolidation, inflation, and patent status |
| 2026 |
$680 |
Continued inflation, increased manufacturing costs |
| 2027 |
$700 |
Potential price stabilization if generics or biosimilars enter |
Projected annual growth rate: approximately 2-3%, considering competitive pressures, regulatory factors, and inflation.
Regulatory and Policy Influences
- Patent expirations: While U-500 insulin's primary patents extend into 2025, biosimilar entrants are unlikely before 2024.[2]
- Biosimilar landscape: Entry of biosimilar concentrated insulins could drive prices down, but current market barriers restrict rapid entry.
- Pricing legislation: Federal and state initiatives targeting drug price transparency and Medicare negotiations could result in downward pressure.
Key Takeaways
- The U.S. insulin market is growing, with U-500 insulin capturing a niche segment for high-dose therapy.
- Prices are projected to increase gradually, with a compounded annual growth rate of 2-3% over the next five years.
- Competitive pressure from biosimilars and legislative reforms could influence future prices.
FAQs
Q1: What are the primary factors affecting the price of Humulin R U-500?
A1: Manufacturing costs, inflation, patent status, insurance negotiations, and potential biosimilar competition.
Q2: How does U-500 insulin differ from U-100 insulin?
A2: U-500 has five times the insulin in the same volume, reducing injection volume for patients requiring high doses.
Q3: Are biosimilars expected to enter the U-500 insulin market soon?
A3: Biosimilar entry is unlikely before 2024 due to patent protections and regulatory hurdles.
Q4: How does the pricing of Humulin R U-500 compare globally?
A4: Prices are generally lower outside the U.S., affected by healthcare policies, patent laws, and market competition.
Q5: What impact could legislation have on U-500 insulin prices?
A5: Legislation targeting drug price transparency and Medicare negotiations could suppress prices over time.
Citations
[1] Allied Market Research. (2023). Insulin Market by Product Type.
[2] U.S. Patent and Trademark Office. (2022). Patent expiration timelines for insulin products.
