Last updated: February 20, 2026
What is NDC 69680-0114?
NDC 69680-0114 corresponds to Benralizumab (Fasenra), a monoclonal antibody approved for the treatment of severe eosinophilic asthma. It was approved by the FDA in November 2017. The drug is marketed by AstraZeneca and is administered via subcutaneous injection.
Market Overview
Indications and Patient Population
Benralizumab targets patients with severe eosinophilic asthma characterized by high eosinophil counts. According to the CDC, approximately 6.8% of US adults have asthma, with about 20-25% classified as severe. This equates to roughly 4 million adults potentially eligible for benralizumab.
Competitive Landscape
Benralizumab competes primarily with:
- Mepolizumab (Nucala)
- Reslizumab (Cinqair)
- Dupilumab (Dupixent)
These therapies target different pathways but aim at reducing eosinophil levels or Th2 inflammation. Market share distribution as of 2023:
| Drug |
Estimated US Market Share |
Approximate Annual Revenue (USD millions) |
Launch Year |
| Mepolizumab |
50% |
2,600 |
2018 |
| Benralizumab |
30% |
1,560 |
2017 |
| Reslizumab |
10% |
520 |
2016 |
| Dupilumab |
10% |
520 |
2017 |
Revenue Trends
Benralizumab's revenues increased from $200 million in 2018 to roughly $1.56 billion in 2022, driven by expanding indications and increasing adoption.
Distribution Channels
Distribution occurs via specialty pharmacies, hospitals, and directly through healthcare providers. Cost barriers, insurance coverage, and formulary placements significantly influence prescribing trends.
Pricing Structure
Current List Price
In the U.S., the list price per dose (30 mg) is approximately $4,300, with the standard approved dosing schedule being:
- 30 mg subcutaneously every 4 weeks for the first 3 doses
- Then every 8 weeks afterward
Estimated Annual Cost
Assuming a patient receives 7 doses annually (after initial loading), the annual treatment cost approximates $30,100.
| Dosing Schedule |
Doses per Year |
Approximate Cost (USD) |
Notes |
| Initial 3 doses, then every 8 weeks |
7 |
\$30,100 |
Based on list price |
Reimbursement Dynamics
Insurance coverage and patient assistance programs influence the actual cost to payers and patients, often reducing the net cost significantly.
Price Projections (2023–2028)
Influencing Factors
- Patent Expiry: The patent for benralizumab expires around 2035, delaying biosimilar entry.
- Market Share Growth: Expected to stabilize around 35–40%, driven by increased off-label use and expanded indications.
- Price Trends: Based on historical data and comparator analysis, prices are likely to decrease by 3–5% annually due to market competition and payer pressure.
Projected List Price
| Year |
Estimated List Price (USD per dose) |
Rationale |
| 2023 |
$4,300 |
Current pricing |
| 2024 |
$4,100 |
4.7% decrease driven by competitive pressures |
| 2025 |
$3,900 |
Continued price erosion |
| 2026 |
$3,700 |
Patent remains in place, but price pressures exist |
| 2027 |
$3,530 |
Slight further reduction |
| 2028 |
$3,350 |
Market adjustments, payer negotiations |
Revenue Projections
Assuming stable patient population and unit price decreases, annual revenues for AstraZeneca could decline slightly after 2024, with total sales around $1.4 billion by 2028.
Regulatory and Policy Impact
Biosimilar Development
No biosimilar has entered the market yet; biosimilar development could commence after patent expiry (~2035), potentially reducing prices by 20–30% upon approval.
Policy Shifts
Price controls and value-based reimbursement models could accelerate price decreases pre- and post-patent expiry.
Summary of Key Data
| Parameter |
Value |
| Current list price per dose |
$4,300 |
| Annual treatment cost |
$30,100 |
| Estimated US patient population for severe eosinophilic asthma |
1 million–1.2 million |
| Current market share (2023) |
30% |
| Projected price decline (2023–2028) |
4–5% annually |
| Patent expiry |
2035 |
Key Takeaways
- Benralizumab remains a significant segment in severe asthma treatment, capturing roughly 30–35% of the market.
- List prices are expected to decline gradually due to competitive pressures and payer negotiations.
- Total revenues will plateau or decline modestly post-2024 as prices decrease.
- Biosimilar entry and policy changes may accelerate downward pressure after patent expiry.
FAQs
Q1: How does the price of benralizumab compare to other biologics for asthma?
A1: The list price of benralizumab (~$4,300 per dose) is comparable to mepolizumab and dupilumab, though exact costs vary by dosing schedule and payer discounts.
Q2: What factors could influence the actual price paid by insurers?
A2: Negotiated discounts, patient assistance programs, formulary status, and insurance plan design significantly impact the net price.
Q3: When are biosimilars likely to enter the market?
A3: Biosimilars for benralizumab could emerge after patent expiration around 2035, assuming no delays.
Q4: How does the market outlook change with potential expanded indications?
A4: Expanded indications would increase the eligible patient base, potentially stabilizing revenue despite price declines.
Q5: What is the primary driver of market share for benralizumab?
A5: Physician familiarity, insurance formulary placement, and clinical trial outcomes influence market share more than pricing alone.
References
[1] Centers for Disease Control and Prevention. (2022). Asthma surveillance data. https://www.cdc.gov/asthma/data.htm
[2] IQVIA. (2023). Asthma biologics market data.
[3] AstraZeneca. (2022). Fasenra product label.
[4] FDA. (2017). FDA approval letter for Benralizumab.
