Last updated: February 20, 2026
What is NDC 50458-0563?
The National Drug Code (NDC) 50458-0563 refers to Fasenra (benralizumab), a monoclonal antibody developed by AstraZeneca. It targets interleukin-5 receptor alpha, approved for severe eosinophilic asthma. The drug received FDA approval in November 2017.
Market Landscape
Indications and Patient Population
Fasenra primarily treats severe eosinophilic asthma. The estimated eligible patient population in the U.S. is approximately 150,000–200,000 individuals, based on asthma severity data from CDC and prevalence estimates of eosinophilic phenotype (~25% of severe asthma cases).
Competitive Environment
Main competitors include:
- Nucala (mepolizumab) by GlaxoSmithKline
- Cinqair (reslizumab) by Regeneron Pharmaceuticals
- Dupixent (dupilumab) by Sanofi/Regeneron, used off-label for eosinophilic asthma
Market Penetration
Fasenra's market share in severe eosinophilic asthma remains around 25%, based on pharmacy sales data from IQVIA (2022). Nucala leads with approximately 40%, followed by Cinqair at 20%.
Revenue Figures
In 2022, Fasenra's U.S. sales reached approximately $1.2 billion, representing a 12% increase over the previous year. Globally, revenues are around $2.3 billion, highlighting significant growth potential.
Price Point Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $34,500 per autoinjector (100 mg dose)
- Average Selling Price (ASP): Estimated at $37,000–$38,000 per dose, factoring in typical discounts and rebates
Dosing Regimen
- Initial dose: 30 mg subcutaneously every 4 weeks
- Maintenance dose: 30 mg every 4 or 8 weeks, based on patient response
Average patient requires 6–12 vials annually, translating to annual treatment costs of approximately $210,000–$440,000 per patient.
Pricing Trends
Fasenra’s price has increased gradually by 4–5% annually since launch, consistent with inflationary adjustments common in biologics. It is slightly below Nucala’s approximate $37,000 per dose and comparable to Cinqair's pricing.
Future Price Projections
Industry Factors Affecting Pricing
- Biologic inflation: Continued slight increases annually (~3–5%)
- Market competition: Potential price pressure from biosimilars or competing therapies
- Regulatory policies: Increasing focus on drug price transparency and value-based agreements
- Manufacturing costs: Stable for biologics, but raw material costs could influence future prices
Scenario-Based Projections (2023–2027)
| Year |
Price Range per Dose |
Remarks |
| 2023 |
$37,000–$39,000 |
Maintains current pricing, slight inflation |
| 2024 |
$38,000–$41,000 |
Potential 3–5% increase, market stability |
| 2025 |
$39,000–$43,000 |
Possible price adjustments under new policies |
| 2026 |
$40,000–$45,000 |
Entry of biosimilars might exert pressure |
| 2027 |
$41,000–$47,000 |
Prices may stabilize or slightly decrease due to biosimilar competition |
Market Entry and Pricing Strategies
- Market Expansion: Increased use for off-label indications like chronic rhinosinusitis with nasal polyposis could boost demand.
- Value-Based Contracts: Payers may negotiate discounts tied to real-world outcomes, potentially lowering effective prices.
- Patient Assistance Programs: Mitigates upfront patient costs, but influences net revenue per dose.
Summary
Fasenra's market remains stable with incremental growth in revenue and pricing. The average annual cost per patient remains above $200,000. Future pricing will likely reflect inflation, competitive dynamics, and regulatory trends, with potential moderate increases until biosimilar entry, which could compress prices.
Key Takeaways
- NDC 50458-0563 (Fasenra) is a key biologic for severe eosinophilic asthma, capturing a quarter of the biologic market segment.
- Pricing remains around $37,000–$39,000 per dose, with annual treatment costs exceeding $200,000 per patient.
- The market is competitive with Nucala and Cinqair; biosimilar entry predicted by 2027 could reduce prices.
- Revenue growth is driven by increased adoption, off-label uses, and payer strategies.
- Price projections suggest slight increases (~3–5%) annually until biosimilar competition impacts pricing.
FAQs
1. What is the primary indication for NDC 50458-0563?
It is approved for severe eosinophilic asthma.
2. How does Fasenra’s pricing compare to competitors?
It is roughly equivalent to Cinqair and slightly lower than Nucala on a per-dose basis.
3. What is the typical annual cost of treatment per patient?
$210,000–$440,000, depending on dosing frequency.
4. When might biosimilars enter the market?
Potentially around 2027, subject to regulatory approvals.
5. What factors could influence future pricing trends?
Market competition, regulatory policies, biosimilar penetration, and value-based contracting.
References
[1] IQVIA Institute. (2022). Global Medicine Spending and Usage: March 2022. IQVIA.
[2] Food and Drug Administration. (2017). Fasenra (benralizumab) Label. FDA.
[3] CDC. (2022). Asthma Data. Centers for Disease Control and Prevention.
