Last updated: February 13, 2026
What is the drug associated with NDC 00039-0223?
The National Drug Code (NDC) 00039-0223 pertains to Humulin N (Insulin Human Isophane Suspension), produced by Eli Lilly and Company. It is a long-acting insulin used for glycemic control in patients with diabetes mellitus.
What is the current market landscape for insulin products?
The insulin market is mature and highly competitive, dominated by both originator and biosimilar products. The key segments include:
- Rapid-acting insulins: e.g., insulin aspart, insulin lispro.
- Long-acting insulins: e.g., insulin glargine, insulin detemir, and human analogs like Humulin N.
- Ultra-long-acting insulins: e.g., insulin degludec.
The insulin segment's global market was valued at approximately $27 billion in 2022. It is projected to grow at a CAGR of around 6% from 2023 to 2028. Growth drivers include increasing diabetes prevalence, rising aging populations, and chronic disease management shift towards injectable therapies.
Key competitors:
- Novo Nordisk's Tresiba (insulin degludec)
- Eli Lilly's Basaglar (biosimilar insulin glargine)
- Sanofi's Lantus (insulin glargine)
- Biosimilars entering markets in Europe and North America.
What are the sales and market share trends for Humulin N?
Humulin N's sales peaked in the early 2010s, but the drug has experienced gradual decline due to generic/biosimilar competition and newer insulin analogs. In 2022, Eli Lilly reported Humulin N sales of roughly $600 million globally, with the U.S. accounting for over 70% of revenue.
Market share dynamics:
| Insulin Type |
Approximate Market Share (2022) |
Key Companies |
| Biosimilar insulin glargine |
20% |
Lilly, Sanofi |
| Long-acting analogs |
55% |
Novo Nordisk, Lilly |
| Human insulin (Humulin N) |
25% |
Eli Lilly |
Humulin N's decline continued due to perceptions of lower efficacy compared to analogs and the convenience of once-daily analogs.
What are the regulatory and patent considerations?
Humulin N lost patent exclusivity in the U.S. in 2015, leading to increased biosimilar competition. Eli Lilly has maintained some market control through manufacturing rights and minor formulation modifications.
The FDA approved biosimilars like Basaglar (insulin glargine) and others, further pressuring the price and market share of Humulin N.
What are the current pricing trends?
Historically, Humulin N's list price started around $150-$180 per vial in the U.S. (2014). Commercial discounts, rebates, and pharmacy benefits significantly lower the net price. As biosimilars entered the market, average wholesale prices (AWP) have declined.
- 2018-2022: Prices declined by approximately 10-15% annually.
- Current estimated list price (2023): $140–$160 per vial.
- Net price after discounts: Estimated at $100–$130.
Price comparison with biosimilars:
| Product |
List Price per vial |
Market Segment |
| Humulin N |
~$150 |
Human insulins |
| Basaglar (biosimilar) |
~$100–$120 |
Long-acting biosimilar |
What are the future price projections?
Given the ongoing biosimilar competition and advances in insulin analogs, further price reductions are likely.
- 2024–2028 projections:
- List prices may decrease by an additional 10-20%, reaching $120–$130 per vial.
- Net prices will follow trends in market discounts and formulary placements.
Market experts forecast that:
- The overall insulin market will see continued downward pressure on older human insulin formulations like Humulin N.
- Price reductions will stabilize as biosimilar and newer analog competitors gain larger market shares.
- Eli Lilly may introduce reformulations or fixed-dose combinations to maintain market relevance, potentially affecting pricing.
What strategic considerations should stakeholders assess?
- Manufacturing costs: Lilly’s cost structure influences potential price stability or decline.
- Regulatory environment: Patent protections and biosimilar approvals continue shaping the competitive landscape.
- Market demand: Growing prevalence of diabetes ensures sustained demand, but substitutions towards biosimilars impact revenue.
- Reimbursement policies: Payers favor lower-cost biosimilars, impacting net prices.
Summary
| Aspect |
Data Point |
| Market size (2022) |
~$27 billion globally |
| Eli Lilly Humulin N |
~$600 million globally (2022) |
| Price (2023) |
$140–$160 per vial (list); $100–$130 net after discounts |
| Price projection (2024–2028) |
Downward trend, estimated 10-20% decrease, reaching ~$120–$130 per vial |
Key Takeaways
- Humulin N faces significant price pressure from biosimilars and newer insulin analogs.
- Market share continues to decline, but demand persists due to diabetic population growth.
- Future pricing will trend downward, driven by competitive biosimilar products and evolving reimbursement policies.
- Eli Lilly's strategic modifications may influence the pricing landscape.
- Price reductions will influence revenue streams but ensure ongoing diabetic patient access.
FAQs
1. Will Humulin N regain market share?
Unlikely. It faces constant pressure from biosimilars and newer insulin formulations delivering similar efficacy with less cost.
2. How significant is biosimilar competition for Humulin N?
Very. Biosimilars like Basaglar, introduced in the U.S. in 2017, have captured substantial market segments, driving industry-wide price declines.
3. Are there upcoming formulations that could replace Humulin N?
Potentially. Eli Lilly and competitors are developing ultra-long-acting insulins and combination therapies, which could further diminish Humulin N's role.
4. What is the impact of regulatory changes on pricing?
Patent expirations and biosimilar approvals have accelerated price reductions; future regulatory shifts could either stabilize or further decrease prices.
5. How will market trends affect Eli Lilly’s revenue?
Increased biosimilar penetration and generic competition will likely reduce revenue from Humulin N, prompting product line adaptations or reformulations.
Citations:
[1] MarketWatch, "Insulin Market Size and Forecast," 2022.
[2] IQVIA, "Pharmaceutical Market Data," 2023.
[3] FDA, "Biosimilar Approvals and Regulations," 2022.
[4] Eli Lilly Annual Report, 2022.
