Last updated: March 4, 2026
What is NDC 61269-0402?
NDC 61269-0402 identifies Mepolizumab (Nucala), a monoclonal antibody used to treat severe eosinophilic asthma and other eosinophil-associated diseases. Approved by the FDA in 2015, it is marketed by GlaxoSmithKline. The drug is administered via subcutaneous injection, generally every four weeks.
Market Size Overview
Therapeutic Indication and Patient Population
- Primary indication: Severe eosinophilic asthma
- Estimated patient population in the U.S.: Approximately 250,000–300,000
- Additional uses include eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).
Historical Market Data (2020–2022)
| Year |
U.S. Prescriptions (units) |
Revenue (USD millions) |
| 2020 |
350,000 |
1,200 |
| 2021 |
425,000 |
1,400 |
| 2022 |
500,000 |
1,560 |
The upward trend correlates with increased diagnosis rates and approval of expanded indications.
Competitive Landscape
Main Competitors
- Benralizumab (Fasenra) – Another IL-5 receptor antagonist, approved in 2017.
- Reslizumab (Cinqair) – IL-5 antagonist, approved in 2016.
- Dupilumab (Dupixent) – IL-4 receptor alpha antagonist, approved in 2018 for severe eosinophilic asthma.
Market Share Breakdown (2022)
| Product |
Estimated Market Share |
Annual Revenue (USD millions) |
| Mepolizumab |
45% |
700 |
| Benralizumab |
30% |
470 |
| Reslizumab |
15% |
235 |
| Dupilumab |
10% |
155 |
Key Market Drivers
- Increased prevalence of eosinophilic asthma
- Growing recognition of eosinophil-driven diseases
- Expansion of indications and dosing guidelines
- Reimbursement coverage improving with broader payer acceptance
Price Dynamics and Projections
Current Pricing (2023)
- List Price: Approximately $32,500 per prefilled syringe (100 mg dosage)
- Average Wholesale Price (AWP): Similar to list price
- Net Price after Rebates and Discounts: Estimated at 20–25% lower than list price
Price Trends (2018–2023)
| Year |
List Price per 100 mg syringe |
Estimated Net Price |
Comments |
| 2018 |
$30,000 |
$22,500 |
Initial launch, steady pricing |
| 2020 |
$32,000 |
$24,000 |
Slight increase |
| 2022 |
$32,500 |
$24,375 |
Price stabilization |
Future Price Projections (2024–2028)
- Expected to maintain a compound annual growth rate (CAGR) of 1–2%
- Possible price stabilization due to competitive pressures
- Reimbursement policies may impact net prices downward
| Year |
Projected List Price |
Expected Net Price (after discounts) |
| 2024 |
$32,700 |
$24,500 |
| 2025 |
$33,000 |
$24,750 |
| 2026 |
$33,300 |
$25,000 |
| 2027 |
$33,600 |
$25,250 |
| 2028 |
$33,900 |
$25,500 |
Cost-Effectiveness Thresholds
- Cost per QALY (Quality-adjusted life year): Estimated at $150,000–$200,000
- Payor approval is most likely in cases where clinical benefits justify costs, influencing net price negotiations.
Regulatory and Policy Impacts
- CMS and Payer Policies: Shifting toward value-based arrangements may pressure net prices.
- Patent Expiry and Biosimilars: No biosimilar approval as of 2023, though biosimilar pathways exist in FDA regulations.
- Pricing Transparency Initiatives: Push for disclosure may influence future pricing models.
Key Takeaways
- NDC 61269-0402 (Mepolizumab) has a growing market, primarily driven by increased diagnosis and expanded indications.
- Competition from IL-5 receptor antagonists and IL-4 inhibitors constrains pricing power.
- Current list price stands around $32,500 per syringe, with net prices estimated at about $24,000–$24,500.
- Price growth is moderate, around 1–2% annually, with potential downward pressure from payor negotiations.
- Market share dominance is split among the IL-5 class, but Mepolizumab remains a leader due to early approval and broad adoption.
FAQs
1. How does NDC 61269-0402 compare in price to competitors?
It has a higher list price than Reslizumab but is comparable to Benralizumab, with Dupilumab generally costing more due to broader indications.
2. What factors influence future pricing for Mepolizumab?
Reimbursement policies, competition, clinical adoption, patent landscape, and biosimilar entry will impact pricing.
3. Are biosimilars expected for Mepolizumab?
As of 2023, no biosimilars have been approved, but biosimilar development is ongoing, potentially affecting market dynamics post-2025.
4. How significant is the role of insurance coverage in pricing?
Insurance coverage heavily influences net price realization, with payors negotiating rebates and discounts to control costs.
5. What is the outlook for the global market?
Growth outside the U.S. hinges on local acceptance, approval of new indications, and healthcare infrastructure, with emerging markets showing potential.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2015). FDA Approval Details for Mepolizumab.
[3] Bloomberg Industry Reports. (2023). Biologic Drug Pricing and Market Trends.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement and Policy Updates.
[5] FDA. (2023). Biosimilar Guidance and Pathways.
