Last updated: February 15, 2026
Overview of the Drug
NDC 62135-0528 corresponds to Gvoke Pre-Filled Syringe (glucagon injection, for subcutaneous use). Gvoke is a glucagon analog used in hypoglycemia management, marketed by Xeris Pharmaceuticals. It was approved by the FDA in 2019 for treating severe hypoglycemia in diabetic patients. It offers an alternative to traditional glucagon kits, which require reconstitution before administration.
Market Dynamics
Gvoke operates within the emergency hypoglycemia treatment market, which is estimated at approximately $350 million in the U.S. as of 2022, with projections reaching $500 million by 2027[1]. This segment is driven by the rising prevalence of diabetes (estimated at 37.3 million Americans, or 11.3% of the population, in 2020) and increased awareness of hypoglycemia management[2].
Key Competitors
- Glucagon Emergency Kits (e.g., Lilly’s GlucaGen hypoKit).
- Nasal Glucagon (e.g., Baqsimi by Eli Lilly).
- Other pre-measured glucagon injectables (e.g., Xeris’s Gvoke) and emerging formulations.
Price points are influenced by formulation ease, safety profile, and insurance reimbursement. Gvoke’s pre-filled syringe is priced higher than traditional kits but may command a premium due to convenience.
Pricing Trends and Projections
| Market Year |
Projected Sales (USD millions) |
Key Price Drivers |
Notes |
| 2022 |
50 |
Competitive pricing, insurance coverage |
Estimated based on current market penetration |
| 2023-2024 |
70-100 |
Increased adoption, wider insurance coverage |
Growth driven by formulary inclusion |
| 2025-2027 |
120-200 |
Price increases, expanded indications |
Price per unit projected around $125-150, reflecting inflation and payer negotiations[3] |
Price Per Unit
In 2022, Gvoke’s retail price ranged around $150-$180 per syringe. Market speculation suggests that with increased adoption, average wholesale prices (AWP) may rise modestly, reaching approximately $160-$180 in 2023, with potential for slight increases to $200 by 2027 due to inflation and value-based pricing models.
Pricing Considerations
- Insurance coverage reduces out-of-pocket costs, potentially stabilizing prices.
- Drug accessibility programs may influence net prices, especially for uninsured patients.
- Competition from nasal glucagon formulations, priced at approximately $200 per dose, influences Gvoke’s pricing strategy[4].
Regulatory and Reimbursement Environment
- The Centers for Medicare & Medicaid Services (CMS) and private payers are increasingly favoring formulary inclusion for simplified administration products.
- Medicare Part D rebates and negotiations significantly impact net pricing.
- Value-based care initiatives could pressure price adjustments downward if cost-effectiveness can be demonstrated.
Market Expansion Potential
- Expansion into pediatric populations remains pending regulatory approval.
- Hospital emergency departments could serve as distribution channels, expanding market reach.
- Global markets remain largely untapped; European approval could diversify revenue streams.
Conclusion
Gvoke’s market position is shaped by its convenience relative to traditional glucagon kits and nasal formulations. Pricing is expected to stabilize around $150-$200 per dose, with sales growth driven primarily by increased adoption, payer coverage, and competitive positioning within the hypoglycemia treatment landscape.
Key Takeaways
- NDC 62135-0528 (Gvoke) is a pre-filled glucagon syringe, launched in 2019.
- U.S. hypoglycemia treatment market projected to grow to $500 million by 2027.
- Current average price per syringe: $150-$180; expected to trend upward modestly.
- Growth driven by increased diabetes prevalence, formulary expansion, and product convenience.
- Competitive pressures from nasal glucagon influence pricing strategies.
FAQs
1. How does Gvoke's pricing compare to traditional glucagon kits?
Gvoke costs significantly more, typically around $150-$180 per dose, whereas traditional kits cost approximately $25-$40. The higher price reflects its convenience, pre-measured dosing, and ease of use.
2. What are the main factors influencing Gvoke's market penetration?
Insurance reimbursement, physician prescribing habits, patient acceptance, and formulary inclusion are key factors. The convenience advantage over reconstitution kits is also critical.
3. How will competition affect future pricing?
Nasal glucagon formulations priced around $200 per dose introduce competition, which may limit price increases for Gvoke. Market dynamics may lead to modest price stabilization or slight reductions.
4. What is the outlook for expanding Gvoke's indications?
Regulatory approval for pediatric use or hospital settings could broaden the market. Current growth prospects rely on increased adoption within existing indications.
5. What are the key regulatory risks for Gvoke?
Potential approval delays, safety concerns, or rejection of new indications could impact sales. Regulatory agencies may also require post-marketing studies impacting pricing and reimbursement.
References
[1] EvaluatePharma, 2022. Market size estimates for emergency hypoglycemia treatments.
[2] CDC, 2020. National Diabetes Statistics Report.
[3] MarketResearch.com, 2023. Future pricing analysis for glucagon products.
[4] Statista, 2022. Nasal glucagon pricing and market comparison.
