Last updated: February 21, 2026
What is NDC 76204-0030?
NDC 76204-0030 corresponds to Gvoke Pre-Filled Syringe (glucagon for injection). It is indicated for severe hypoglycemia treatment in patients with diabetes. Gvoke was approved by the FDA in August 2019 and is marketed by Xeris Pharmaceuticals.
Market Overview
Product Positioning and Competition
Gvoke operates in the emergency hypoglycemia treatment market, competing primarily with established products:
- Glucagon Emergency Kits (e.g., GlucaGen, Glucagon Emergency Kit 1 mg).
- Nasal glucagon (e.g., Baqsimi), approved in 2019, gaining market share due to ease of administration.
Market Size
The global diabetes market was valued at approximately USD 72.8 billion in 2022, with hypoglycemia treatments representing about 8-10% of the total. The injectable glucagon market, including Gvoke and comparators, was estimated at USD 300 million in 2022, with a CAGR of approximately 6-8% expected from 2023-2028.
Key Market Drivers
- Increasing prevalence of diabetes worldwide (estimated at 537 million adults in 2021, projected to reach 643 million by 2030 [1]).
- Adoption of more convenient administration routes, favoring Gvoke’s pre-filled syringe over traditional kits.
- Growing awareness of hypoglycemia management among patients and caregivers.
- Payer coverage expansion, facilitated by favorable formulary placements and demonstration of use in diverse settings.
Distribution and Market Penetration
Gvoke is available through multiple channels: hospitals, community pharmacies, and online. Its penetration varies geographically, with higher adoption in the U.S., where awareness and reimbursement coverage are significant.
Price History and Current Pricing
- Launched at approximately USD 120-150 per pre-filled syringe (2019-2020).
- Market price has stabilized around USD 100-125 per unit as of 2023.
- Reimbursement strategies and patient assistance programs influence effective out-of-pocket costs.
| Year |
Average Wholesale Price (AWP) |
Estimated Out-of-Pocket Price |
| 2020 |
USD 140 |
USD 80-100 |
| 2021 |
USD 130 |
USD 75-95 |
| 2022 |
USD 120 |
USD 70-90 |
| 2023 |
USD 125 |
USD 75-95 |
Prices have experienced slight reductions attributed to increased competition and formulary negotiations.
Price Projections
Short-Term (2023-2025)
- Expect stability or marginal decline in unit price owing to competitive pressures.
- Anticipated lower reimbursements and increased use of nasally administered glucagon may substitute traditional injectable options.
Long-Term (2026+)
- Price may decline further to USD 80-100 per unit as generics or biosimilar-like products enter the market.
- Continued price pressure from alternative delivery forms (e.g., nasal, auto-injectors) and generic glucagon powders.
- Premium pricing sustainability depends on increased adoption and value demonstration.
Regulatory and Market Dynamics Impacting Pricing
- Reimbursement Environment: Medicaid, Medicare, and private insurers' policies influence net prices significantly.
- Patent and Patent Expiry: Gvoke’s exclusivity extends through at least 2027, with potential for generic entries thereafter.
- New Entrants: Increased competition from nasal glucagon products could pressure injectable prices.
Key Takeaways
- The global hypoglycemia treatment market is growing, with Gvoke positioned as a convenient injectable option.
- Current prices hover around USD 100-125 per unit, with potential declines aligning with market competition.
- Reimbursement, market adoption, and competition from alternative delivery forms will shape future price trajectories.
- Price reductions are likely in the long-term, especially as generics and biosimilars enter the market post-2027.
- Marketing strategies emphasizing ease of use and value can influence the potential for premium pricing sustainability.
FAQs
Q1: When is Gvoke expected to face generic competition?
A1: Likely from 2027 onward, contingent upon patent expirations and regulatory approvals.
Q2: How does Gvoke compare price-wise to nasal glucagon products?
A2: Nasal glucagon typically costs USD 200-300 per dose, higher than Gvoke’s USD 100-125, but market preferences influence substitution patterns.
Q3: What are the reimbursement prospects for Gvoke?
A3: Coverage remains favorable in many insurers, but continued negotiations and market penetration influence reimbursement levels.
Q4: How sensitive are prices to market entry of biosimilars?
A4: Very sensitive; biosimilar entries tend to reduce prices, especially if they demonstrate equivalency and gain insurance coverage.
Q5: What is the expected growth rate for hypoglycemia injectable markets?
A5: Approximately 6-8% CAGR projected from 2023-2028, driven by rising diabetes prevalence and awareness.
References
[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th edition.
