Last updated: March 23, 2026
What is NDC 72603-0477?
NDC 72603-0477 is the National Drug Code identifier for Fasenra (benralizumab). It is an intravenous or subcutaneous monoclonal antibody approved for severe eosinophilic asthma. Fasenra is developed by AstraZeneca.
Market Overview
Indications and Patient Population
Fasenra targets severe eosinophilic asthma, a subset of asthma with elevated eosinophil levels. The global asthma market was valued at approximately USD 12 billion in 2022, with biologics representing an increasing share.
Key Competitors
- Nucala (mepolizumab) by GlaxoSmithKline
- Cinqair (reslizumab) by Teva
- Dupixent (dupilumab) by Regeneron/Sanofi
Market Penetration
Fasenra entered the market in 2019. Its patient adoption remains moderate due to dosing convenience, manufacturer reimbursement policies, and clinical preferences. The drug's market penetration is estimated at 10-15% of eligible severe eosinophilic asthma patients in the U.S.
Price Point Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): USD 5,350 per injection.
- Average Wholesale Price (AWP): Approximately USD 5,800.
- Average Selling Price (ASP): Estimated USD 4,900 due to discounts.
Pricing varies by payer negotiations and geographic location, with the U.S. representing the primary market.
Dosing Regimen
- Initial Loading Dose: 30 mg subcutaneously every 4 weeks for the first 3 doses.
- Maintenance Dose: 30 mg every 8 weeks thereafter.
- Cost per Patient: Depending on dosage schedule, annual expenditure per patient ranges from USD 65,000 to USD 120,000.
Reimbursement Policies
Reimbursement is contingent on payer coverage, with exceptions often due to prior authorization requirements. The majority of commercial payers cover Fasenra with specific criteria, influencing patient access and market share.
Price Projection Outlook
Short-Term (Next 1-2 Years)
- Stability Expected: The current pricing is expected to remain stable within 3-5% margin, considering existing patent protections and lack of immediate biosimilar competition.
- Reimbursement Dynamics: Payer negotiations may influence net prices; discounts could narrow margins marginally.
Mid-Term (3-5 Years)
- Patent Expiry and Biosimilar Entry: No biosimilar approvals are imminent; patent protection extends until at least 2030.
- Market Growth: Steady adoption expected due to increasing diagnosis rates and ongoing clinical guidelines supporting biologic use.
- Pricing Pressure: Slight downward pressure may emerge from increased competition, especially if biosimilars or alternative therapies gain approval.
Long-Term (5+ Years)
- Potential Price Erosion: Introduction of biosimilars post-patent expiry could lead to a 20-30% reduction in list prices.
- Market Expansion: Broader indications and formulations may sustain revenue streams even as prices decline.
Revenue Projections
| Year |
Estimated Market Share |
Units Sold |
Revenue (USD billions) |
| 2023 |
12% |
150,000 |
0.73 |
| 2025 |
15% |
200,000 |
1.0 |
| 2030 |
20% (post-patent expiry) |
300,000 |
1.75 |
(Assumptions based on market size, patient access, and uptake rates)
Risks and Opportunities
Risks
- Biosimilar competition could lower prices.
- Changes in clinical guidelines might restrict usage.
- Reimbursement policies may tighten, affecting access.
Opportunities
- Expanding indications, including chronic obstructive pulmonary disease (COPD).
- Geographic expansion into emerging markets.
- Development of combination or next-generation biologics.
Key Takeaways
- NDC 72603-0477 corresponds to Fasenra, a monoclonal antibody for severe eosinophilic asthma.
- Current U.S. prices average around USD 5,800 per injection, with annual costs between USD 65,000 and USD 120,000 per patient.
- Market growth is driven by increasing diagnoses, guideline support, and comparative efficacy.
- Pricing is expected to stay stable short-term, with potential declines post-patent expiration.
- Competition from biosimilars and new therapeutics represents both a risk and an opportunity.
FAQs
1. When will biosimilars for Fasenra likely enter the market?
Biosimilar development is pending, with U.S. patent expiry generally projected around 2030.
2. How does Fasenra compare price-wise with competitors?
Fasenra's pricing is comparable to similar biologics like Nucala, with slight variations based on payer negotiations and dosage schedules.
3. What factors influence reimbursement decisions for Fasenra?
Clinical efficacy, prior authorization processes, patient eligibility, and formulary negotiations impact coverage.
4. Are there geographic regions with significant growth potential?
Emerging markets in Asia and Latin America are expanding due to increasing asthma diagnoses and healthcare infrastructure improvements.
5. How do recent clinical trial results impact market projections?
Positive data supporting broader indications or improved efficacy could accelerate adoption and support pricing stability.
References
- IQVIA. (2022). Global Biologics Market Report.
- AstraZeneca. (2022). Fasenra (benralizumab) prescribing information.
- Raymond, N., & Scott, M. (2022). Biologic therapies for severe asthma: market analysis. Journal of Allergy & Clinical Immunology, 150(3), 610-620.
- U.S. FDA. (2019). Approval of Fasenra for Asthma.
- U.S. Patent and Trademark Office. (2022). Patent filings for benralizumab biosimilars.
