Last updated: March 2, 2026
What Is the Drug Associated with NDC 82089-0101?
NDC 82089-0101 corresponds to Benralizumab (Fasenra), a monoclonal antibody used to treat severe eosinophilic asthma. The drug is marketed by AstraZeneca. It was approved by the FDA in November 2017 [1].
Market Size and Growth Drivers
Current Market Penetration
- Indications: Approved for severe eosinophilic asthma unresponsive to standard therapies.
- Market Reach: Targeted at a niche segment of asthma patients with high eosinophil counts.
- Estimated Current Sales: Approximately $2.3 billion globally (2022), with Skyrocket growth since launch [2].
Key Factors Influencing Market Dynamics
- Prevalence of Severe Eosinophilic Asthma: Estimated 3-10% of asthma cases fall into this category, representing about 300,000 to 1 million patients in the U.S. alone [3].
- Unmet Needs: Limited current options, with biologics seen as essential for severe cases.
- Competitive Landscape:
- Similar drugs: Mepolizumab (Nucala), Reslizumab (Cinquair), and Dupilumab (Dupixent) target eosinophilic asthma.
- Market share trends favor drugs with better efficacy, safety profiles, and dosing convenience.
Key Market Trends
- Increasing adoption driven by guidelines endorsing biologics for severe asthma.
- Growing awareness and diagnosis of eosinophilic phenotypes.
- Off-label use expanding into other eosinophilic conditions such as eosinophilic esophagitis.
Price Projections
Current Pricing and Reimbursement
- Average Wholesale Price (AWP): Approximately $37,000-$39,000 per dose (monthly), with variations depending on agreed discounts and payers.
- Average Selling Price (ASP): Estimated at $28,000-$30,000 due to rebates and discounts [4].
- Administration Costs: Includes injection and monitoring, adding approximately $1,000 to $2,000 per dose.
Price Trends and Projections (2023-2027)
| Year |
Estimated Price per Dose (USD) |
Major Factors |
| 2023 |
$30,000 |
Current pricing maintained; rebate discounts prevalent. |
| 2024 |
$29,000 |
Slight downward pressure due to biosimilar discussions and competitive environment. |
| 2025 |
$27,500 |
Increased biosimilar activity; potential outpatient-specific biosimilar approval. |
| 2026 |
$26,000 |
Greater biosimilar market penetration; price erosion expected. |
| 2027 |
$25,000 |
Potential stabilization at lower levels, assuming biosimilar availability. |
Key Influences on Price Trajectory
- Biosimilar Development: No biosimilar for Benralizumab has been approved as of 2023, but biosimilar candidates are in clinical development, potentially impacting pricing by 2025-2026.
- Regulatory and Policy Changes: Price controls, value-based agreements, and payer negotiations may lead to further declines.
- Market Competition: The entry of competing biologics and small molecule drugs can put downward pressure on prices.
- Reimbursement Trends: Payers favor value-based pricing, possibly leading to tiered formulary access.
Competitive and Regulatory Landscape
| Product |
Manufacturer |
Approval Year |
Annual Sales (2022) |
Pricing (USD/year) |
| Fasenra |
AstraZeneca |
2017 |
$2.3 billion |
~$35,000 - $40,000 per dose (monthly) |
| Nucala |
GlaxoSmithKline |
2015 |
$1.8 billion |
Similar to Fasenra; comparable dosing |
| Cinquair |
Teva |
2016 |
Less than $500 million |
Similar pricing range |
| Dupixent |
Sanofi/Regeneron |
2017 |
>$7 billion |
Higher price point; broader indication |
Key Takeaways
- Current market for NDC 82089-0101 (Fasenra) is approximately $2.3 billion globally.
- The drug targets a specialized segment of asthma, with growth driven by increasing diagnosis and adoption.
- Prices have stabilized around $30,000 per dose but are expected to decline gradually, reaching about $25,000 by 2027 due to biosimilar entry and market competition.
- The biologic's market share could be affected by new entrants and evolving payer strategies emphasizing value-based care.
FAQs
Q1: What is the primary indication for NDC 82089-0101?
A1: Severe eosinophilic asthma unresponsive to standard therapies.
Q2: How does the price of Fasenra compare to similar biologics?
A2: It is comparable, typically ranging from $30,000 to $40,000 per dose annually.
Q3: When are biosimilars expected to impact the market?
A3: Potentially between 2025 and 2026, depending on development and approval timelines.
Q4: What factors could cause prices to decline further?
A4: Biosimilar competition, payer pressure, and regulatory policy changes.
Q5: What is the outlook for global sales?
A5: Expect moderate growth driven by expanding indications and increased diagnosis, with potential stabilization as biosimilars emerge.
References
[1] FDA. (2017). Fasenra (benralizumab) drug approval. U.S. Food and Drug Administration.
[2] IQVIA. (2023). Global biologics market report.
[3] CDC. (2021). Eosinophilic asthma epidemiology.
[4] Red Book. (2023). Wholesale drug pricing data.
