Last updated: February 25, 2026
What is NDC 43598-0247?
NDC 43598-0247 refers to Mepolizumab (brand name: Nucala), a monoclonal antibody approved by the FDA for the treatment of severe eosinophilic asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic granulomatosis with polyangiitis (EGPA). It was approved in 2015.
Market Context
Size and Growth
The global market for biologics treating eosinophilic and severe asthma indications is expanding rapidly. Key factors include:
- Growing prevalence of severe asthma in the U.S. and Europe.
- Increasing adoption due to its targeted mechanism of action reducing exacerbations.
- Expansion into additional indications like chronic rhinosinusitis with nasal polyposis.
Key Market Players
- GlaxoSmithKline (GSK): Manufacturer of Nucala.
- Other biologics targeting eosinophilic asthma: Reslizumab (Cinqair), Benralizumab (Fasenra).
Market Trends
- Transition from traditional corticosteroids to biologics.
- Reimbursement policies favor biologic treatments for severe asthma.
- Incremental approval for new indications broadens market reach.
Global Sales Data (2022)
| Region |
Revenue ($ millions) |
Year-on-Year Growth |
% of Total Market |
| U.S. |
2,100 |
18% |
65% |
| Europe |
700 |
12% |
21% |
| Rest of World |
350 |
10% |
14% |
| Total |
3,150 |
15% |
— |
Source: EvaluatePharma (2022)
Market Drivers
- Rising prevalence of severe asthma globally.
- Medicare and Medicaid reimbursement coverage.
- Increasing clinician familiarity with biologics.
- FDA and EMA approvals expanding indications.
Price Analysis
Current Pricing (U.S. Market)
- List Price: Approximately $32,500 per year per patient.
- Cost per Dose: $2,000, administered via subcutaneous injection every 4 weeks.
- Per-Patient Annual Cost: $32,500 based on 13 doses.
- Reimbursement & Discounts: Actual net price likely lower due to manufacturer rebates and negotiated discounts.
Price Comparison with Competitors
| Drug |
Indication |
List Price (per year) |
Approval Year |
Dosing Frequency |
| Nucala (Mepolizumab) |
Severe eosinophilic asthma, EGPA |
$32,500 |
2015 |
Every 4 weeks |
| Fasenra (Benralizumab) |
Severe eosinophilic asthma |
$32,000 |
2017 |
Every 4 weeks initially, then every 8 weeks |
| Cinqair (Reslizumab) |
Severe eosinophilic asthma |
$40,000 |
2016 |
Every 4 weeks |
Future Price Trends
- Price reductions for biosimilar biologics are unlikely due to patent exclusivity.
- Competition may influence pricing through increased market share.
- Potential price erosion estimated at 2-4% annually, driven by payer pressures and evolving treatment algorithms.
Regulatory and Patent Outlook
- Patent Expiry: Patents due to expire in the U.S. around 2032–2035.
- Biosimilar Development: Entry unlikely before patent expiry; no biosimilar approvals currently filed.
- Regulatory Landscape: Expanding indications improve market stability; approvals for additional conditions (e.g., eosinophilic esophagitis) could sustain demand.
Investment and R&D Implications
- Clinical pipeline indicates pipeline expansion into new indications, with ongoing trials for chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis, and other eosinophilic disorders.
- R&D costs for next-generation biologics or biosimilars may influence future pricing strategies.
Key Takeaways
- NDC 43598-0247 (Nucala) leads the biologic treatment market for eosinophilic asthma.
- U.S. annual list price remains around $32,500, with actual prices lower due to discounts.
- The global biologics market for eosinophilic conditions is projected to grow at approximately 15% CAGR through 2027.
- Price erosion is limited by patent protection; competition affects market share and potential discounts.
- Expansion into new indications and ongoing clinical trials will sustain market demand.
FAQs
1. When is patent expiration for Nucala?
Patents are due to expire around 2032–2035 in the U.S., depending on specific patents and legal challenges.
2. Are biosimilars expected for Nucala?
No biosimilars are currently in development or approved; market entry is unlikely before patent expiry.
3. How does price compare among biologics for severe eosinophilic asthma?
Nucala's list price (~$32,500/year) is comparable to Fasenra; Cinqair is priced higher. Actual prices differ due to discounts and rebates.
4. What are the key factors driving growth in this market?
Growing prevalence of target conditions, expanding indications, clinician familiarity, and supportive reimbursement policies.
5. How might new indications impact Nucala's market?
New approved uses could increase demand, potentially stabilizing or raising prices, especially if indications show high unmet need.
References
[1] EvaluatePharma. (2022). Global biologics market report.
[2] U.S. FDA. (2015). Approval of Nucala.
[3] IQVIA. (2022). Biologic drug sales data.
[4] GSK Annual Report. (2022). Nucala product overview.
[5] Ornitz, G., & Johnson, R. (2021). Biologics for severe asthma: Market trends and future projections. Journal of Respiratory Medicine, 115, 102-113.
