Last updated: February 25, 2026
What is the Drug with NDC 69367-0330?
The National Drug Code (NDC) 69367-0330 identifies Insulin Aspart, a rapid-acting insulin used for blood sugar control in diabetes mellitus. This formulation is marketed under the brand name Fiasp, manufactured by Novo Nordisk.
Market Landscape
Market Size and Demand
- The global insulin market reached approximately $30 billion in 2021, with anticipation of compound annual growth rate (CAGR) of 8-10% over the next five years (IQVIA, 2022).
- U.S. insulin sales account for roughly 40% of global revenue, driven by increasing diabetes prevalence. The U.S. Diabetes population is estimated at 37 million (CDC, 2020).
- Rapid-acting insulins, including insulin aspart, constitute about 25-30% of the total insulin market and are projected to grow due to increased adoption in both Type 1 and Type 2 diabetes management (EvaluatePharma, 2022).
Competitive Environment
- Key competitors include Novo Nordisk’s NovoRapid and Eli Lilly’s Lispro brands.
- Fiasp is positioned as a premium product, marketed for its faster onset compared to traditional rapid-acting insulins.
- Patent protections and exclusivity periods influence market access and pricing strategies.
Regulatory Status
- Approved by the FDA in 2017.
- Pending or ongoing biosimilar development and regulatory filings could impact future market share.
Price Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (AWP) per 10 mL vial |
2022 Data |
Sources |
| United States |
$300 |
|
[1] |
| European Union |
€170 (approx. $200) |
|
[2] |
In the U.S., the per-unit cost for Fiasp is approximately $3.00-$3.50 per unit, with variations based on purchasing channels, rebates, and insurance coverage.
Historical Price Movements
- U.S. insulin prices have increased approximately 10-15% annually over the past five years.
- Price increases correlate with increased manufacturing costs, limited competition, and market exclusivity periods.
Future Price Projections (Next 5 Years)
| Year |
Projected Wholesale Price per 10 mL vial |
Assumptions |
Sources |
| 2023 |
$330 |
5% increase from 2022 |
Market trend |
| 2024 |
$350 |
Inflation and manufacturing cost rise |
Industry reports |
| 2025 |
$370 |
Limited biosimilar entry, market control |
Expert analysis |
| 2026 |
$390 |
Continued patent protection, demand persists |
Market lock-in |
Note: Price caps or negotiations under Medicare/Medicaid could alter retail prices.
Pricing Dynamics Influencing Future Trends
- Biosimilar Competition: Entry of biosimilar insulin products is anticipated by 2024-2025, which could threaten premium pricing and induce a reduction of 10-20% in insulin prices.
- Patent Expiry & Legal Challenges: Patent expiry on Fiasp and rapid-acting insulin analogs in North America and Europe may prompt price reductions.
- Market Penetration Strategies: Novo Nordisk’s potential initiatives include differential pricing, patient assistance programs, and strategic partnerships to maintain market share.
Strategic Considerations for Stakeholders
- Manufacturers: Invest in biosimilar development to hedge impact of patent expiration.
- Insurers & PBMs: Negotiate formulary placements to control costs amid rising insulin prices.
- Investors: Monitor patent life and biosimilar approval timelines with potential for price erosion post-2024.
Key Takeaways
- NDC 69367-0330 (Fiasp) commands prices in the U.S. of approximately $3.00-$3.50 per unit.
- The global insulin market is growing annually at 8-10%.
- Price growth is expected to plateau or decrease with biosimilar competition anticipated in 2024-2025.
- Market dominance relies on patent protections, clinical advantages, and patient adoption.
- Biosimilar entry and regulatory shifts present significant risks and opportunities for pricing strategies.
FAQs
1. How does Fiasp differ from other rapid-acting insulins?
Fiasp contains faster-absorbing formulations, reducing onset time and offering better post-meal blood sugar control.
2. When are biosimilar insulins expected to enter the market?
Regulatory approvals are projected for 2024-2025, with some biosimilars already in late-stage development.
3. What are the main drivers of insulin price increases?
Manufacturing costs, limited competition, patent protections, and supply chain factors. Political and policy measures also influence pricing.
4. How might insurers impact Fiasp pricing?
Insurance formularies and rebate negotiations can reduce out-of-pocket costs and influence retail prices.
5. What risks do biosimilar competitors pose to Fiasp?
Biosimilars could lead to 10-20% price reductions and loss of market share, particularly if they gain rapid regulatory approval and broad payer acceptance.
References
[1] IQVIA. (2022). Pharmaceutical market data: U.S. insulin sales analysis.
[2] EvaluatePharma. (2022). Global Insulin Market Report.
[3] CDC. (2020). National Diabetes Statistics Report.
