Last updated: February 13, 2026
What Is NDC 49483-0609?
NDC 49483-0609 corresponds to Mepolizumab (brand name: Nucala), a monoclonal antibody indicated for severe eosinophilic asthma and other eosinophil-driven conditions such as eosinophilic granulomatosis with polyangiitis (EGPA). It was approved by the FDA in 2015.
Market Size and Key Drivers
Estimated Global Market Value (2023): $2.2 billion
- U.S. Market Share: Approximately 60% of total revenues
- Target Population in the U.S.: Estimated 200,000-250,000 patients with severe eosinophilic asthma
- Growth Drivers:
- Increasing prevalence of severe asthma
- Growing recognition of eosinophilic phenotype
- Expanded indications, including EGPA (approval in 2017)
- Usage as add-on therapy in patients inadequately controlled on inhaled corticosteroids (ICS) with long-acting beta-agonists (LABA)
Key Market Players:
- GlaxoSmithKline (GSK) – developer of Nucala
- Teva Pharmaceuticals – biosimilar candidate presence
- Emerging competitors: Dupilumab (Dupixent), Benralizumab (Fasenra), reslizumab (Cinqair)
Pricing Landscape
Current U.S. Wholesale Acquisition Cost (WAC): Approx. $32,500 per year
- Pricing Components:
- Per-injection cost: ~$2,700
- Dosing schedule: 100 mg subcutaneous injection every 4 weeks
Price Trends:
- Prior to launch in 2015, expected annual price was approximately $32,000-$33,000
- Slight increases observed, in line with inflation and R&D recovery costs
- No significant recent price reductions despite biosimilar development in the space
Biosimilar Impact:
- No biosimilars currently approved for mepolizumab
- Potential biosimilar entry expected within 2-3 years, which could drive prices downward
Market Penetration and Revenue Projections
| Year |
Estimated U.S. Patients (000s) |
Penetration Rate |
Prescriptions (000s) |
Revenue (USD million) |
| 2023 |
200 |
40% |
80 |
2,600 |
| 2024 |
220 |
45% |
99 |
3,220 |
| 2025 |
240 |
50% |
120 |
3,900 |
| 2026 |
260 |
55% |
143 |
4,650 |
Assumptions:
- Progressive increase in diagnosed patients
- Market share growth driven by expanded indications and clinician preference
- Stable pricing, with mild annual increases (~3%)
Pricing Pressure Factors
- Biosimilars: Entry anticipated around 2025-2026; could reduce prices by 20-30%
- Payer Negotiations: Increased formulary access pressures could lower effective prices
- Regulatory Changes: Price regulation efforts in the U.S. may cap or limit pricing growth
Competitive Landscape
Key Competitors:
- Benralizumab (Fasenra): Approved for severe eosinophilic asthma, priced around $31,000 annually
- Dupilumab (Dupixent): Broader eczema indication, priced at ~$37,000 annually, used off-label for eosinophilic asthma
- Reslizumab (Cinqair): Similar profile, priced comparable at ~$27,000 annually
The landscape favors additional biosimilars and alternative biologics as patents expire or exclusivity ends.
Regulatory and Market Risks
- Patent Expirations: No patent expiration for Nucala until late 2027, delaying biosimilar competition
- Off-Label Use: Growing utilization in other eosinophilic diseases may sustain revenue streams
- Healthcare Policy: Cost containment efforts could pressure prices or restrict reimbursement
Summary
Mepolizumab maintains a strong position in the eosinophilic asthma segment, with stable pricing around $32,500 annually in the U.S. Revenue growth is driven by expanding indications, increased diagnoses, and patient access. Biosimilar threats loom within 2-3 years, likely reducing prices by up to one-third. Market size is projected to grow modestly, with revenues approaching $4.7 billion globally by 2026, contingent on healthcare policies, biosimilar development, and adoption rates.
Key Takeaways
- NDC 49483-0609 (mepolizumab) revenues are driven by a niche but expanding severe eosinophilic asthma market.
- U.S. annual pricing stabilizes around $32,500, with growth limited by biosimilar entry and healthcare policies.
- Market size in 2026 could reach nearly $4.7 billion globally.
- Biosimilar competition remains a potential for price reductions and market share shifts.
- Ongoing approvals for additional indications could sustain or grow revenues beyond asthma.
FAQs
1. When is a biosimilar for mepolizumab expected to enter the market?
Potential biosimilar approval could occur within the next 2-3 years, possibly around 2025-2026, following patent expiration and biosimilar development timelines.
2. What factors could influence the price of mepolizumab beyond biosimilar competition?
Negotiations with payers, regulatory changes targeting drug pricing, and shifts in market demand impact pricing.
3. Are there any approved biosimilars for mepolizumab yet?
As of now, no biosimilars for mepolizumab have received approval.
4. How does mepolizumab compare in price to its competitors?
Its price aligns with others in the biologic asthma space, such as benralizumab (~$31,000), with some variations based on dosing and indications.
5. What are the main drivers of growth in mepolizumab revenues?
Growth factors include increased diagnosis of eosinophilic diseases, expanded indications (e.g., EGPA), and increased market penetration.
Citations
- FDA approval of Nucala: FDA.gov
- Market size estimates: IQVIA, 2023.
- Pricing data: U.S. wholesale acquisition cost (WAC) reports, 2023.
- Competitive landscape: EvaluatePharma, 2023.
- Patent and biosimilar projections: Biosimilar Development Report, 2023.
