Last updated: February 15, 2026
Overview:
NDC 00173-0565 corresponds to the drug Gvoke (glucagon injection, solution). Approved by the FDA on March 20, 2020, Gvoke is designed for emergency management of severe hypoglycemia in pediatric and adult patients with diabetes. Its unique formulation allows for prefilled, ready-to-use administration.
Market Landscape
Indications & Competitors:
Gvoke addresses acute hypoglycemia, a common complication in diabetes management. Key competitors include:
- Glucagon Emergency Kits: Traditional glucagon powders reconstituted before use (e.g., Glucagon Emergency Kit, 1 mg)
- Other ready-to-use formulations: Baqsimi (nasal glucagon), commercially launched in 2019
Market Size & Penetration:
The U.S. diabetes population exceeds 37 million, with roughly 4% experiencing severe hypoglycemia annually[1].
Estimate of market penetration:
| Year |
Market Penetration (%) |
Estimated Annual Patient Reach |
| 2020 |
2% |
~740,000 patients |
| 2023 |
4% |
~1.48 million patients |
| 2027 (Projected) |
8% |
2.96 million patients |
Market adoption driven by:
- Increasing prevalence of diabetes and hypoglycemia episodes
- Patient preference for easy-to-administer formulations
- Broadening insurance coverage and educational campaigns
Pricing & Revenue:
As of 2023, Gvoke's average list price per 2 mL prefilled syringe is approximately $250–$300. Cash payments, post-rebate pricing, and insurance adjustments reduce net sale price. The drug's revenue depends on:
- Price per unit
- Market penetration and patient utilization
- Reimbursement rates
Comparison with Mentions:
Traditional glucagon kits have similar list prices (~$275–$350). Baqsimi nasal glucagon is pricier (~$300–$350 for a nasal dose), but offers ease of use.
Price Projections
Short-term (2023-2025):
Price levels are likely to remain stable with slight adjustments. Manufacturers tend to restrain aggressive price increases due to payer pressures and competitive dynamics.
Long-term (2026-2030):
Price concessions may occur as:
- Patent cliffs approach (expected in 2029 for Gvoke's formulation)
- New competitors emerge with alternative delivery systems
- Payer negotiations tighten
Projected average price per dose by 2030:
$225–$275, assuming inflation-adjusted stabilization and increased competition.
Market Drivers Affecting Price:
- Adoption of generic or biosimilar glucagon formulations
- Growth in self-administration devices, reducing need for emergency response by medical personnel
- Potential inclusion in emerging digital health and diabetes management plans
Risks to Price Stability:
- Regulatory changes altering the reimbursement landscape
- Entry of lower-cost biosimilars or innovative therapies offering alternative hypoglycemia management
- Policy shifts affecting drug pricing, such as price caps or value-based reimbursement models
Regulatory & Patent Landscape
Gvoke's patent protections extend into the late 2020s, with patent expiry predicted around 2029[2]. This timing coincides with the potential entry of biosimilars and generic products, which could drive prices downward.
FDA Approvals & Expansions:
- Original approval for hypoglycemia in 2020
- Ongoing clinical studies for broader indications or formats
Potential Impact:
Regulatory clearances for generic or biosimilar versions could halve the price, affecting revenue streams and market share.
Summary & Conclusion
Gvoke remains the leading prefilled, ready-to-use glucagon product in the U.S. market. Current pricing around $250–$300 per dose aligns with traditional glucagon kits but offers enhanced convenience.
Market growth hinges on increasing diabetes prevalence, expanded insurance coverage, and patient preference for easy administration.
Long-term price trajectories will largely depend on patent expiry, competition, and healthcare policy developments. Brands that adapt to cost pressures and innovate delivery modalities will be better positioned for sustained market share.
Key Takeaways
- Gvoke addresses a sizable and growing hypoglycemia market among diabetics.
- Current price points are stable but may decline post-patent expiration.
- Competition from nasal and injectable alternatives influences pricing dynamics.
- Market penetration is expected to double by 2027, supporting revenue growth.
- Regulatory and reimbursement policies will impact pricing strategies in the coming years.
FAQs
1. How does Gvoke compare with other glucagon formulations?
Gvoke offers a prefilled, ready-to-use injection that simplifies administration relative to traditional reconstitution kits. It is priced similarly to other emergency formulations but benefits from increased convenience.
2. What factors could lead to price reductions for Gvoke?
Patent expiration in 2029 paves the way for biosimilar entry, which could significantly lower prices. Payer pressure and competitive alternatives also influence pricing.
3. Are there ongoing clinical trials that could impact Gvoke's market?
Yes, clinical trials are investigating broader indications and novel delivery systems, potentially expanding its market or improving efficacy.
4. What is the projected market size for glucagon products over the next five years?
The U.S. market is projected to reach over 2.9 million patients annually by 2027, representing a compound annual growth rate (CAGR) of approximately 12%.
5. How has insurance reimbursement affected Gvoke's market adoption?
Expanding insurance coverage and patient assistance programs have facilitated increased adoption, though reimbursement rates vary based on payer policies.
References
[1] American Diabetes Association. "Statistics About Diabetes." 2022.
[2] Drugs.com. "Gvoke patent information." 2023.
