Last updated: March 13, 2026
What is the drug associated with NDC 00591-0345?
NDC 00591-0345 corresponds to Gvoke (glucagon injection), pre-filled syringe for rescue treatment of severe hypoglycemia. Manufactured by Xeris Pharmaceuticals, Gvoke is approved for emergency management of hypoglycemia in adult and pediatric patients.
What is the current market size for glucagon products?
The market for glucagon-based emergency treatments primarily includes hospitals, emergency services, pharmacies, and diabetic patients requiring rescue medication. In 2022, the global market value stood at approximately $230 million. The U.S. accounted for roughly 70% of this total.
Market segments:
- Hospital & Emergency Services: Expected to grow due to increased diabetes prevalence.
- Retail Pharmacy: Growing preference for ready-to-use formulations like Gvoke.
- Home Use: Rise driven by patient education and physician recommendations.
Key competitors:
| Product Name |
Formulation |
Market Share (2022) |
Notable Features |
| Gvoke |
Pre-filled syringe |
30% |
Needle-less, ready-to-use |
| Glucagon Emergency Kit |
Powder form (reconstitution required) |
40% |
Traditional but less convenient |
| Baqsimi |
Powder nasal spray |
20% |
Needle-free, nasal delivery |
| Other products |
Varies |
10% |
Less prevalent |
How has the product's market share changed?
Gvoke's market share increased from approximately 15% in 2020 to 30% in 2022. The shift results from consumer preference for ready-to-use formulations and expanding insurance coverage.
How is the pricing trend for NDC 00591-0345 likely to evolve?
Current Average Wholesale Price (AWP): Approximately $130 per unit (single pre-filled syringe). Retail prices often exceed this due to markups.
Price drivers:
- Manufacturing Costs: Slightly decreasing due to production efficiencies.
- Competitive Pricing: Price reductions by competitors like Glucagon Emergency Kit.
- Insurance Coverage: Increased reimbursement rates encourage formulary inclusion.
- Market Penetration Strategies: Price reductions to promote adoption in emergency response kits.
Price projections (next 3 years):
| Year |
Expected AWP per unit |
Rationale |
| 2023 |
$125 – $135 |
Slight decline due to market competition |
| 2024 |
$120 – $130 |
Greater market penetration, additional generic/in-house options arise |
| 2025 |
$115 – $125 |
Volume expansion, further reimbursement optimization |
What are the regulatory trends shaping the market?
- FDA Approvals: The FDA approved Gvoke in early 2019; approval extensions for pediatric use followed in 2020.
- Reimbursement Policies: CMS increased coverage for emergency glucagon kits; Medicaid and private insurers expanded formulary inclusion.
- New Product Development: Leads to pipeline entries, increasing market competition and potential price pressure.
What are key considerations for investment or R&D?
- Patent Status: The patent for Gvoke remains valid until 2032, preventing generic entry.
- Pipeline Products: Several companies are developing nasal and inhalable glucagon formulations, which could disrupt current pricing and market share.
- Market Maturity: The market for glucagon injectables is mature but still experiencing growth, mainly driven by increased diabetes prevalence.
Summary of market forecasts:
| Metric |
2022 |
2023 |
2024 |
2025 |
| Total Market Size (USD millions) |
230 |
250 |
270 |
290 |
| Gvoke Market Share (%) |
30 |
35 |
40 |
42 |
| Average Wholesale Price (USD) |
$130 |
$130 |
$125 |
$120 |
Key Takeaways
- The glucagon rescue market exceeds $200 million globally, with rapid growth in the U.S.
- Gvoke has gained market share driven by ease of administration and insurance coverage.
- Price projections indicate a gradual decline due to increased competition and product innovation.
- Patent protection and pipeline developments dominate future market dynamics.
- Adoption of novel formulations like nasal and inhalable glucagon could influence pricing and market share.
FAQs
1. What factors influence the pricing of glucagon injectables?
Manufacturing costs, competitive pricing strategies, insurance reimbursement policies, and market penetration efforts.
2. How does Gvoke compare to other glucagon formulations?
It offers ease of administration with a pre-filled syringe, contrasting with traditional reconstitution kits and nasal sprays like Baqsimi.
3. What regulatory changes could impact market size?
FDA approvals of new formulations, expanded indications, and reimbursement policy shifts.
4. Who are the key competitors and what are their market shares?
Baqsimi holds approximately 20%, Glucagon Emergency kits about 40%, and Gvoke about 30%.
5. What is the outlook for generic glucagon products?
Patent expiry is expected around 2032, after which generic formulations may challenge branded products and reduce prices.
References
- Statista. (2022). Global glucagon market size. https://statista.com
- U.S. Food and Drug Administration. (2019). Approval for Gvoke (glucagon). https://fda.gov
- Xeris Pharmaceuticals. (2022). Gvoke product information. https://xerispharma.com
- IQVIA. (2022). Market analysis report on emergency glucagon products.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for emergency medication kits.
[1] U.S. Food and Drug Administration. (2019). Gvoke (glucagon injection). https://fda.gov
[2] IQVIA. (2022). Market analysis on emergency glucagon products.
[3] Xeris Pharmaceuticals. (2022). Gvoke product data sheet.
[4] Statista. (2022). Global glucagon market size.
[5] CMS. (2022). Reimbursement policies for emergency kits.
