Last updated: February 15, 2026
Overview
NDC 60505-2677 is marketed as Gvoke, a prefilled syringe containing glucagon for adult and pediatric emergency treatment of severe hypoglycemia. The drug is manufactured byXeris Pharmaceuticals. It became available in the U.S. market in 2020 after FDA approval in 2019.
Market Size and Demand Drivers
Gvoke primarily targets healthcare providers, emergency medical services, and diabetes patients with high risk of severe hypoglycemia. Its market size depends on the prevalence of diabetes, hypoglycemia episodes, and adoption of non-injectable formulations.
- Diabetes Prevalence: Estimated at 34 million Americans as of 2022[1].
- Severe Hypoglycemia Incidence: Approximately 1-2% of diabetics experience severe episodes annually[2].
- Market Penetration: Gvoke aims at expanding emergency treatment options, competing with existing products like Glucagon Emergency Kit (by Eli Lilly) and Glucagon injection (by Novo Nordisk).
Competitive Landscape
The key competitors include:
- Eli Lilly’s Glucagon Emergency Kit: Market leader with established distribution.
- Novo Nordisk’s Glucagon: Used in non-prescription and hospital settings.
- Other formulations: Including nasal sprays and concentrated injectable options.
Gvoke differentiates via ease of administration, prefilled syringes, and user-friendly design.
Market Penetration and Growth Trends
- Initial Launch (2020-2021): Gvoke captured limited market share due to brand recognition of incumbents and distribution challenges.
- Expansion (2022-2023): Efforts to increase awareness, especially among emergency services, and adoption by pharmacies increased sales.
- Projected CAGR: 10-15% over the next five years, driven by rising diabetes prevalence and demand for user-friendly emergency treatments.
Price Analysis
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2022 Average Wholesale Price (AWP): Approximately $300-$350 per unit in the hospital and pharmacy channels.
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List Price: Current list price hovers around $310 per unit.
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Reimbursement: Medicare and private insurers coverage varies; reimbursement rates influence actual prices paid by providers and patients.
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Price Trends:
- Slight increases projected annually, aligned with inflation and dosage improvements.
- Competitive pressure from off-label and alternative delivery methods may limit sharp price hikes.
Price Projection 2023-2028
| Year |
Estimated Price per Unit |
Key Factors |
Notes |
| 2023 |
$310 - $330 |
Market mature, minor inflation |
Price stabilization with slight upward trend due to inflation |
| 2024 |
$320 - $340 |
Increased adoption, wider usage |
Competitive dynamics may temper rapid price increases |
| 2025 |
$330 - $350 |
Product differentiation persists |
Further uptake in emergency services |
| 2026 |
$340 - $360 |
Potential introduction of generic options |
Price may plateau if generics or biosimilars enter the market |
| 2027 |
$350 - $370 |
Market expansion into new settings |
Reimbursement rates may influence actual prices |
Regulatory and Policy Impact
Recent FDA approvals and patent protections support market exclusivity until approximately 2030. Policy initiatives promoting emergency drug access could influence pricing and distribution strategies.
Key Considerations
- Patent landscape solidifies Gvoke’s position until at least 2028.
- Distribution channels and insurance reimbursement policies impact net revenue.
- Competition from alternative delivery formats or biosimilars could pressure prices.
- Market expansion relies on healthcare provider acceptance and emergency preparedness protocols.
Key Takeaways
- Gvoke’s market is driven by diabetes prevalence and the need for convenient hypoglycemia treatment.
- Current average wholesale prices range from $300 to $350.
- Growth projections suggest a 10-15% CAGR in sales volume, with prices increasing slowly.
- Market share remains sensitive to reimbursement policies and competitive developments.
- Price stability is expected in the near term, with potential for increases as adoption expands.
FAQs
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When is Gvoke expected to face generic competition?
Patent protections extend until roughly 2030, minimizing immediate generic threats.
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What factors most influence Gvoke’s pricing?
Insurance reimbursement policies, competitive pressures, and manufacturing costs.
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How does Gvoke’s use case affect its market stability?
Its role as an emergency drug provides consistent demand among high-risk populations.
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Are there upcoming regulatory changes that could impact pricing?
New policies promoting emergency drug access or incentives for biosimilars could affect prices.
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What geographic markets are most promising for Gvoke expansion?
U.S. market remains dominant; international expansion depends on regulatory approvals and healthcare infrastructure.
Citations
[1] CDC. National Diabetes Statistics Report, 2022.
[2] Miller, B. et al. "Epidemiology of Severe Hypoglycemia," Diabetes Care, 2020.
