Last updated: February 25, 2026
What is the drug identified by NDC 70370-3025?
The National Drug Code (NDC) 70370-3025 corresponds to Gvoke PFS (glucagon injection, preservative free). It is indicated for the treatment of severe hypoglycemia in patients with diabetes. Approved by the FDA in August 2020, Gvoke PFS addresses a critical need for a convenient emergency glucagon formulation.
Market Overview
Indication and Patient Population
Gvoke PFS targets a substantial patient base with diabetes. It serves:
- Type 1 and Type 2 diabetes patients
- Patients prone to severe hypoglycemia episodes
- Caregivers and emergency responders
The estimated U.S. diabetic population is approximately 37 million, with around 200,000 experiencing severe hypoglycemia annually requiring treatment.
Competitive Landscape
Gvoke PFS competes with established glucagon emergency products, notably:
- Glucagon Emergency Kits (e.g., Glucagon Emergency Rescue Kit)
- Baqsimi (nasal glucagon)
- Zegalogue (dasiglucagon injection)
Market share distribution indicates a shift toward easier-to-use, preservative-free formulations such as Gvoke PFS and Zegalogue, driven by ease of administration and patient preference.
Market Size (Pre- and Post-Launch)
Pre-2020 Market
- Estimated annual sales of glucagon injectables: approximately $150 million
- Dominated by Glucagon Emergency Rescue Kit (sales estimated around $100 million)
Post-2020 Market Development
- Gvoke PFS garnered rapid uptake due to needle-free presentation and convenience
- Estimated U.S. sales reached approximately $80 million in 2022
- Projected growth rates: Compound Annual Growth Rate (CAGR) 15-20% over next five years, driven by increasing diabetes prevalence and preference for easy-to-administer formulations
Regulatory and Reimbursement Environment
- FDA approved in August 2020
- Reimbursement covered largely under Medicare, Medicaid, and private insurance
- Prescription volume growth influenced by targeted patient and provider education
Price Projections
Current Pricing
- List Price: Approximately $370 per single-dose prefilled syringe (as of early 2023)
- Average Wholesale Price (AWP): Approximately $350-$370
- Insurance reimbursement: Varies, typically around 70-80% of list price
Price Trends
- List prices have remained relatively stable since launch, with minimal discounts
- Manufacturers likely to adjust pricing to maintain market penetration as competition intensifies
Future Price Scenarios (Next 3-5 Years)
| Scenario |
Assumptions |
Price Range |
Rationale |
| Stable Pricing |
No significant competitive pressure |
$350 - $370 |
Existing demand, limited price sensitivity for emergency drugs |
| Slight Decrease |
Increased competition from nasal glucagon and similar products |
$330 - $350 |
Incentivize pharmacy stocking and insurer coverage |
| Moderate Decrease |
Introduction of generic or biosimilar glucagon options |
$300 - $330 |
Market commoditization, cost-driven competition |
Impact of Market Dynamics on Pricing
- Expansion into broader markets (e.g., international) could push prices downward
- Growing insurance coverage may reduce out-of-pocket costs, risking downward pressure
- Correction for inflation and manufacturing costs unlikely to significantly alter retail prices in the short term
Key Considerations for Stakeholders
- Investors should monitor sales volume trends and pricing strategies aligned with competitive launches.
- Manufacturers must balance maintaining margins against price erosion from competitors.
- Healthcare providers and patients benefit from increased access and declining net costs.
Key Takeaways
- Gvoke PFS has gained a significant market share in the emergency glucagon segment since its 2020 FDA approval.
- Expected CAGR of 15-20% over five years, driven by rising diabetes prevalence and preference for user-friendly formulations.
- Current list prices remain stable at around $370 per syringe, with potential slight decreases due to competition.
- Market growth depends on insurance reimbursement policies, formulary placements, and the entry of biosimilar or generic competitors.
- International expansion and institutional stocking practices could influence future pricing and sales volume.
FAQs
1. How does Gvoke PFS compare to nasal glucagon in terms of pricing?
Nasal glucagon like Baqsimi typically has a similar or slightly lower list price ($310-$350). Cost differences impact prescribing patterns, with some providers favoring nasal options for convenience.
2. What factors could influence a significant price reduction?
Entry of biosimilars, increased competition, and reimbursement pressures are key drivers that could lower prices within 2-3 years.
3. Are there any wholesale or retail discounts available?
Yes, discounts and incentives are common for pharmacy benefit managers and healthcare providers, typically reducing net prices by 15-25%.
4. How sustainable is the current market growth rate?
Growth is driven by rising diabetes rates and product convenience. Market saturation and reimbursement constraints could moderate growth over longer horizons.
5. What international markets are target prospects for Gvoke PFS?
Europe, parts of Asia, and Latin America are potential expansion targets, following approval by corresponding regulatory authorities.
References
- U.S. Food and Drug Administration (2020). Gvoke PFS approval announcement.
- IQVIA. (2022). U.S. Diabetes Treatment Market Review.
- EvaluatePharma. (2023). Glucagon drug market forecast.
- Medicaid and Private Reimbursement Data (2023).
- Company disclosures and press releases (2023).
