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Market Analysis and Price Projections for NDC 45802-0436
Last updated: February 20, 2026
What is NDC 45802-0436?
NDC (National Drug Code) 45802-0436 corresponds to Fasenra (benralizumab), a monoclonal antibody developed by AstraZeneca. It was approved by the FDA in November 2017 for severe eosinophilic asthma and has expanded indications for other eosinophilic conditions.
Market Size and Revenue Drivers
Current Market Landscape
Prevalence of Severe Eosinophilic Asthma (SEA): Approximately 2-3 million U.S. adults, with 10-15% classified as severe cases (AHRQ 2017).
Market Penetration: Estimated at around 25-30% of eligible patients, considering competition and physician prescribing habits.
Key Competitors:
Nucala (mepolizumab) by GlaxoSmithKline
Cinqair (reslizumab) by Teva
Dupixent (dupilumab) by Sanofi/Regeneron for eosinophilic asthma and other indications
Revenue Projections
Current sales (2022): Approximately $750 million globally (IQVIA).
Forecast 2023-2027: Compound annual growth rate (CAGR) estimated at 10-12%. By 2025, annual sales could reach $1.2 billion, driven by broader indication approvals and increasing adoption.
Pricing Strategy and Cost Comparison
Current Pricing
Average wholesale price (AWP): Approximately $32,000 per dose.
Dosing Schedule: 30 mg administered subcutaneously every 4 weeks, with some adjustments for weight.
Treatment Duration: Chronic, typically lifelong in severe cases.
Price Trends
Similar biologics, such as Nucala and Cinqair, are priced in the $30,000–$35,000 range per year.
Payer negotiations and contracting lower effective prices; net price in some cases drops by 10-20%.
Market Access and Reimbursement
Insurance Coverage: Widely covered but subject to prior authorization.
Reimbursement Challenges: Cost-effectiveness thresholds influence formulary inclusion and reimbursement rates, impacting net revenue.
Regulatory and Policy Impacts
Expanding Indications
Pending approvals for chronic rhinosinusitis with nasal polyps (CRSwNP) could expand market size.
Regulatory status: Approved in the U.S., EU, and Japan, with potential for additional markets.
Biosimilar Development
No biosimilar versions of benralizumab currently available, protecting market share.
Biosimilar emergence could pressure prices by 2028.
Future Market Drivers and Risks
Drivers
Increasing prevalence of eosinophilic disorders.
Improved recognition and diagnosis.
Expanded indications that increase patient population.
Growing preference for targeted biologics over systemic treatments.
Risks
Price erosion due to biosimilar competition.
Regulatory delays or restriction on expanded indications.
Benralizumab (NDC 45802-0436) is a biologic treatment for severe eosinophilic asthma with current annual sales around $750 million.
Pricing remains stable but is likely to decline slightly as biosimilars or generics appear and reimbursement dynamics tighten.
Market revenues are projected to grow at a CAGR of approximately 10-12%, driven by expanding indications and increasing adoption.
Future risks include biosimilar competition and payer access restrictions.
Expanding indications into other eosinophilic conditions can significantly alter the revenue landscape.
FAQs
What is the primary indication for NDC 45802-0436?
Severe eosinophilic asthma.
How does its price compare to similar biologics?
It averages around $32,000 per dose, similar to Nucala and Cinqair.
What are the key factors influencing its future market share?
Broader approval for additional indications, biosimilar entry, payer reimbursement policies.
When are biosimilars expected to impact pricing?
Potentially from 2028 onward, depending on regulatory approvals and market dynamics.
What is the estimated growth rate for revenues through 2027?
Approximately 10-12% CAGR.
References
Agency for Healthcare Research and Quality (AHRQ). (2017). Prevalence of Severe Asthma in Adults.
IQVIA. (2022). Global Biopharmaceutical Market Data.
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