Last updated: March 2, 2026
What is NDC 00409-4888?
NDC 00409-4888 is a product listed in the National Drug Code database. It corresponds to Nucala (mepolizumab), a monoclonal antibody developed by GlaxoSmithKline. Approved for severe eosinophilic asthma, hypereosinophilic syndrome, and other eosinophil-related conditions, it has a significant market presence within biologic treatments for eosinophilic diseases.
Market Overview
Market Size and Growth
The biologic asthma market, valued at approximately $25 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 8% through 2027 [1]. Nucala holds an estimated 35% share within the severe eosinophilic asthma segment, making it a leading treatment option.
Key Competitors
- Fasenra (benralizumab) by AstraZeneca
- Cinqair (reslizumab) by Teva
- Dupixent (dupilumab) by Sanofi/Regeneron
Each targets eosinophilic and related inflammatory pathways, but Nucala's affinity for eosinophil reduction positions it favorably within the niche.
Market Drivers
- Increasing prevalence of eosinophilic asthma
- Growing adoption of biologics over inhaled corticosteroids
- Expanding indications, including hypereosinophilic syndrome and eosinophilic esophagitis
- Preference for targeted therapies with favorable safety profiles
Geographic Penetration
The U.S. accounts for about 65% of global sales, driven by reimbursement policies and physician familiarity. Europe constitutes 25%, with Asia and other regions comprising the remainder. Market penetration correlates with healthcare infrastructure and pricing strategies.
Pricing Analysis
Current Pricing
The average wholesale price (AWP) for Nucala is approximately $4,300 per 100 mg dose. Patients typically require one to two doses monthly, translating to annual costs:
| Dosing |
Cost per Dose |
Annual Cost (12 doses) |
| 100 mg |
$4,300 |
$51,600 |
| 150 mg |
$6,450 |
$77,400 |
| Note: Pricing varies based on negotiated reimbursement, patient assistance programs, and geographic location.
Reimbursement and Insurance Coverage
Insurance coverage faces obstacles such as prior authorization and step therapy. Payers are increasingly favoring biologics with demonstrated cost-effectiveness ratios below $50,000 per quality-adjusted life year (QALY) [2].
Price Trends
- No significant reductions over the past three years.
- Potential for slight decreases driven by biosimilar development delays and patent litigations.
- Market entry of competing biologics could pressure pricing in the next 2-3 years.
Price Projections (2023-2028)
| Year |
Estimated Price per 100 mg Dose |
Justification |
| 2023 |
$4,300 |
Current market rate, no biosimilar threat |
| 2024 |
$4,200 |
Slight pressure from biosimilar negotiations |
| 2025 |
$4,000 |
Increased biosimilar development, patent challenges |
| 2026 |
$3,800 |
Potential biosimilar or copycat entry, market pressure |
| 2027 |
$3,700 |
Competitive biosimilar market develops further |
| 2028 |
$3,600 |
Biologics generally see declining prices with patent cliffs |
Risks to Price Stability
- Biosimilar development delays or setbacks
- Patent litigations extending exclusivity
- Changes in reimbursement policies favoring generics or biosimilars
- Deterrence from price reductions by market leadership protection
Key Conclusions
- Nucala dominates its niche but faces increasing competition.
- Price reductions will likely be gradual, influenced by biosimilar activity and evolving reimbursement policies.
- The current high-cost structure sustains revenue but constrains uptake among cost-sensitive payers.
- Price declines projected to reach approximately 15%-20% by 2028 from 2023 levels.
Key Takeaways
- NDC 00409-4888 corresponds to Nucala, a leading biologic for eosinophilic disorders.
- The global biologics market for eosinophilic asthma is expanding at 8% CAGR, with a high degree of competition.
- Current pricing approximates $4,300 per 100 mg dose, with annual treatment costs exceeding $50,000.
- Price projections suggest a gradual decline to about $3,600 per dose by 2028.
- Biosimilars and patent legalities will significantly influence future pricing and market share.
FAQs
What factors influence the price of biologics like Nucala?
Market competition, patent status, manufacturing costs, payer negotiations, and regulatory policies.
How does biosimilar entry affect Nucala’s pricing?
Biosimilar competition can lead to substantial discounts, typically 20%-40% below originator prices.
What are the primary indications for Nucala?
Severe eosinophilic asthma, hypereosinophilic syndrome, eosinophilic granulomatosis with polyangiitis, and eosinophilic esophagitis in specific cases.
Will biosimilars replace Nucala in the coming years?
Likely not immediately; biosimilar development faces scientific and regulatory hurdles, especially in the U.S.
How does Nucala’s cost-effectiveness compare to competitors?
Cost-effectiveness varies by region and outcomes studied but typically ranges between $45,000 and $60,000 per QALY in the U.S., aligning with other biologics in its class.
References
[1] IQVIA. (2023). Global Biologics Market Report.
[2] CVS Health. (2022). Cost-effectiveness and reimbursement strategies for biologics.
