Last updated: March 11, 2026
What is NDC 16571-0834?
NDC 16571-0834 corresponds to Fasenra (benralizumab), a monoclonal antibody indicated for severe eosinophilic asthma. Approved by the FDA in 2017, it is administered via subcutaneous injection.
Market Size and Competitive Landscape
Market Size
The global severe eosinophilic asthma treatment market was valued at approximately $2.8 billion in 2022. The U.S. accounts for about 55% of this market, estimated at $1.54 billion.
Key Competitors
| Drug |
Indication |
Approved Since |
Annual Sales (2022) |
Market Share (2022) |
| Nucala (mepolizumab) |
Severe eosinophilic asthma |
2015 |
$2.25 billion |
80% |
| Cinqair (reslizumab) |
Severe eosinophilic asthma |
2016 |
$160 million |
6% |
| Dupixent (dupilumab) |
Eosinophilic conditions |
2017 |
$8.1 billion |
10% (Asthma segment) |
| Fasenra (benralizumab) |
Severe eosinophilic asthma |
2017 |
$565 million |
4% |
Note: Fasenra’s market share remains limited due to later entry and established competition.
Prescribing Trends
- Steady growth driven by expanding indications and unmet medical needs.
- Approximately 300,000 eligible U.S. patients, with around 200,000 actively treated.
Pricing and Reimbursement
Current Pricing
- In the U.S., Fasenra’s list price per administration is approximately $4,500.
- Typical treatment involves 30 mg subcutaneous injections every 4 weeks initially, then every 8 weeks.
- Estimated annual cost per patient: ~$27,000, depending on dosing adjustments.
Reimbursement Environment
- Managed via commercial insurance, Medicare, and Medicaid.
- Reimbursement success depends on formulary inclusion and prior authorization.
Price Projection (Next 3–5 Years)
Factors Influencing Pricing
- Competitive pressures from Nucala and Cinqair.
- Potential for biosimilar or generic entries, though monoclonal antibodies face high barriers.
- Development and approval of new indications could influence pricing.
Projected Pricing Trajectory
| Year |
Expected Average Price per Dose |
Factors Affecting Price |
| 2023 |
$4,500 |
Stable, with minor adjustments for inflation |
| 2024 |
$4,450 |
Competitive pricing pressures |
| 2025 |
$4,400 |
Potential market saturation; new competitors |
| 2026 |
$4,350 |
Possible biosimilar entry or patent cliffs |
| 2027 |
$4,300 |
Market stabilization |
Revenue Estimates
-
Assuming 50,000 eligible patients on therapy in the U.S. with a 70% penetration by 2027:
[
50,000 \times 70\% \times \$27,600 \text{ (annual cost)} = \$963 million
]
-
Market expansion outside the U.S. could add approximately 15–20% to total revenues.
Regulatory and Policy Impact
- Patent protected until at least 2030.
- Biosimilar development remains restricted by high development costs and regulatory hurdles.
- Payer negotiations may lead to discounts of 10–15% over the forecast period.
Risks and Uncertainties
- Emergence of alternative therapies with superior efficacy or lower costs.
- Changes in regulatory policies affecting reimbursement.
- Patent litigation outcomes.
Key Takeaways
- Fasenra holds a modest share of the severe eosinophilic asthma market, with steady growth expected.
- Pricing is stable but vulnerable to competitive and biosimilar threats.
- Revenue projections depend heavily on market penetration and reimbursement policies.
FAQs
What is the primary competitive advantage of Fasenra?
It offers a once-every-eight-weeks dosing schedule after initial treatments, which can improve patient adherence.
How does Fasenra's pricing compare to competitors?
Fasenra’s list price is comparable to Nucala (~$4,600 per dose). Cinqair’s dosing is typically less frequent but often costs similar per administration due to differences in formulation and administration costs.
Are biosimilars expected for Fasenra?
No biosimilars are currently in advanced development stages, but patent expiry post-2030 may invite biosimilar competition.
How do insurance policies impact Fasenra's market penetration?
Reimbursement depends on formulary placements; high out-of-pocket costs can limit patient access, constraining growth.
What regulatory changes could influence future pricing?
Policy shifts towards value-based pricing and stricter reimbursement criteria may lead to discounts or limited access.
References
- IQVIA. (2023). Pharmaceutical Market Updates.
- FDA. (2017). Fasenra approval letter.
- EvaluatePharma. (2022). World Preview of Oncology and Immunology drugs.
- BioCentury. (2023). Biotech Patent Landscape.
- Medicare.gov. (2023). Part B Drugs & Reimbursement Policies.
[1] U.S. Food and Drug Administration. (2017). Fasenra (benralizumab) prescribing information.
