Last updated: February 25, 2026
What is NDC 00078-0371?
NDC 00078-0371 corresponds to Glucagon for Injection, USP. It is indicated for the treatment of severe hypoglycemia in adults and children with diabetes. Manufactured by Novo Nordisk, this drug is primarily used in emergency settings.
Current Market Landscape
Market Size
The global diabetes treatment market was valued at approximately USD 76 billion in 2022. The insulin and emergency glucagon segments account for significant portions. Glucagon, specifically, is a niche but essential product, with estimated annual US sales in the range of USD 200–300 million.
Key Competitors
- Novo Nordisk: Supply of Glucagon for Injection, USP.
- Eli Lilly: Developing alternative formulations.
- Generic manufacturers: Entering with biosimilar versions.
Regulatory Status
The product has received FDA approval, with recent updates including a new intranasal form. The injectable form maintains patent protection until 2029, restricting biosimilar entry.
Market Drivers
- Rising prevalence of diabetes globally, projected to reach 700 million adults by 2045.
- Increased awareness of emergency management protocols.
- Expansion of healthcare access in emerging markets.
Market Challenges
- High procurement costs in hospital and emergency settings.
- Limited product differentiation—most formulations are similar.
- Potential biosimilar competition post-patent expiry.
Price Trends & Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) per 1 mL |
Notes |
| 2018 |
USD 230 |
Premium for branded injectable. |
| 2020 |
USD 240 |
Slight increase, stable pricing. |
| 2022 |
USD 260 |
Patent-driven stability. |
Current Pricing Basis
- The standard 1 mg/1 mL glucagon injection costs USD 260–280 per unit.
- Hospitals often negotiate lower prices through contracts.
Future Price Projections
- 2023–2025: Expect steady prices, marginal increases (~3% annually), driven by inflation and supply chain factors.
- 2026–2029: Price stability amid patent exclusivity.
- Post-2029: Potential 20–30% decrease if biosimilars enter the market, depending on regulatory approval and competition.
Impact of Biosimilars
Biosimilar development is ongoing. The first biosimilar glucagon product may enter the market after 2029, likely reducing prices by a significant margin. Prices could fall to USD 180–200 per unit, based on trends in biosimilar adoption for similar biologics.
Policy and Reimbursement
- Medicare and Medicaid reimburse at negotiated rates.
- Many private insurers cover glucagon with minimal co-pay.
- Cost-effectiveness analyses favor stockpiling for emergency use, supporting stable demand.
Strategic Considerations
- Manufacturers should prioritize expanding indications.
- Innovating delivery methods (e.g., nasal, auto-injectors) may command premium pricing.
- Contracting strategies with healthcare providers will influence profit margins.
Summary of Pricing Outlook
| Year |
Price Range (USD) |
Key Factor |
| 2023 |
260–280 |
Market stability, inflation |
| 2025 |
268–290 |
Slight price increases |
| 2029 |
260–280 |
Patent expiry, biosimilar entry |
| 2030+ |
180–200 |
Biosimilar competition, price erosion |
Key Takeaways
- NDC 00078-0371 is a critical product in emergency diabetes management with a market valued at hundreds of millions.
- Prices have remained relatively stable through 2022, but biosimilar competition post-2029 is expected to drive downward pressure.
- Market growth correlates with rising diabetes prevalence, but high entry barriers limit new competition before patent expiry.
- Innovation in delivery methods and expanding indications offer avenues for price premiums.
- Payers favor stable pricing, but shifts may occur if biosimilars enter the market.
FAQs
1. When will biosimilars for glucagon likely enter the market?
Post-2029, contingent on regulatory approval, with possible initial entries within 1–2 years thereafter.
2. How do prices of glucagon compare internationally?
US prices are higher than European markets, where negotiated discounts and regulations often lower costs.
3. What factors most influence glucagon injection prices?
Patent protection, manufacturing costs, and market competition.
4. Are there alternative treatments reducing glucagon's market share?
No substantial alternatives for emergency hypoglycemia exist currently; glucagon remains the standard.
5. What opportunities exist for new formulations?
Intranasal and auto-injector forms with improved ease of use may command higher prices and market share.
References
[1] MarketsandMarkets. (2022). Diabetes Care Market.
[2] IQVIA. (2022). US Prescription Market Data.
[3] FDA. (2022). Glucagon Injection Approval and Regulatory Status.
[4] Deloitte. (2021). Biosimilar Market Outlook.
