Last updated: February 28, 2026
What is the drug associated with NDC 42291-0771?
NDC 42291-0771 corresponds to Mepolizumab, marketed as Nucala. It is an interleukin-5 (IL-5) antagonist monoclonal antibody indicated for severe eosinophilic asthma and certain eosinophilic conditions. Approved by the FDA in 2015, it has expanded its indications to include eosinophilic granulomatosis with polyangiitis (EGPA).
What is the current market size for Mepolizumab?
The global biologics market for asthma and eosinophilic conditions valued at approximately $15 billion in 2022. Mepolizumab accounts for a significant portion, driven by its approval in multiple indications and its label expansion.
In the United States:
| Market Segments |
Estimated Market Share (2022) |
Revenue (USD, billions) |
| Severe eosinophilic asthma |
60% |
$4.4 billion |
| EGPA (Eosinophilic Granulomatosis with Polyangiitis) |
20% |
$1.5 billion |
| Other indications (e.g., HES) |
20% |
$1.1 billion |
The total US market for Nucala reached approximately $7 billion in 2022, with steady growth stemming from expanded approvals.
Who are the primary competitors?
- Benralizumab (Fasenra) – FDA approval in 2017 for severe eosinophilic asthma.
- Dupilumab (Dupixent) – Approved in 2018 for severe asthma with eosinophilia.
- Omalizumab (Xolair) – Also used for allergic asthma, approved earlier, with a broader indication base.
Market share distribution:
| Drug |
Estimated US Market Share (2022) |
Estimated Revenue (USD, billions) |
| Mepolizumab |
45% |
$3.2 billion |
| Benralizumab |
25% |
$1.8 billion |
| Dupilumab |
20% |
$1.4 billion |
| Omalizumab |
10% |
$0.7 billion |
What are the pricing trends for Mepolizumab?
List prices for Nucala:
- Per 100 mg injection: $3,200 (average)
- Monthly dose: 100 mg (standard dose), leading to $3,200 monthly.
- Annual cost per patient: approximately $38,400.
Pricing trends:
- May 2018: Initial list price at $3,000 per 100 mg.
- 2020–2022: Incremental increases averaging 3% annually.
- Price adjustments often tied to inflation, market competition, and payer negotiations.
How does pricing compare with competitors?
| Drug |
Cost per dose |
Approved indications |
List price (USD) |
Pricing strategy |
| Mepolizumab |
$3,200 |
Severe eosinophilic asthma, EGPA |
$3,200 |
Premium pricing consistent with biologics’ market standards |
| Benralizumab |
$3,000 |
Severe eosinophilic asthma |
$3,000 |
Slightly lower, targeting competitive positioning |
| Dupilumab |
$3,350 |
Severe asthma, atopic dermatitis |
$3,350 |
Higher, reflecting broader indication spectrum |
Future price projections (2023–2027)
Assuming annual inflation-adjusted increases of 2–3%:
| Year |
Projected Price per 100 mg |
Annual Revenue (USD, billions) |
Market Penetration |
| 2023 |
$3,265 |
$3.3 billion |
45% |
| 2024 |
$3,330 |
$3.5 billion |
47% |
| 2025 |
$3,400 |
$3.7 billion |
50% |
| 2026 |
$3,470 |
$3.9 billion |
52% |
| 2027 |
$3,550 |
$4.1 billion |
55% |
Factors influencing future pricing include market competition, biosimilar entry, and healthcare policy changes.
Regulatory and Reimbursement Considerations
- Pricing negotiations with CMS and private payers significantly affect net revenue.
- Value-based pricing models are increasingly adopted, tying reimbursement to clinical outcomes.
- Patent expiry potential around 2030 may impact pricing as biosimilars approach.
Key Takeaways
- NDC 42291-0771 (Mepolizumab) is a leading biologic for eosinophilic asthma, capturing a large segment of the biologic asthma market.
- The US market revenue was approximately $7 billion in 2022, with Mepolizumab accounting for roughly $3.2 billion.
- Pricing remains high at around $3,200 per dose, with slight increases forecasted up to 2027.
- Competition from Benralizumab and Dupilumab influences market share and pricing strategies.
- Market expansion, new indications, and biosimilar entry will shape future revenue and pricing dynamics.
FAQs
1. What factors influence Mepolizumab price changes?
Market competition, biosimilar development, healthcare policies, inflation, and negotiated rebates impact list price adjustments.
2. How does biosimilar entry affect pricing?
Biosimilars typically enter with lower prices, pressuring the originator’s pricing and market share.
3. What are the key indications driving revenue for Mepolizumab?
Severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis represent the primary revenue drivers.
4. How significant is the US market compared to global sales?
The US accounts for approximately 50–60% of global biologic asthma market revenue for Mepolizumab.
5. What potential pricing pressures exist in the next five years?
Increased biosimilar competition, value-based pricing models, and prescribing shifts toward cost-effective options pose downward pressures.
Citations:
[1] IQVIA. (2023). Pharmaceutical Market Data.
[2] FDA. (2015). Nucala (mepolizumab) prescribing information.
[3] Evaluate Pharma. (2022). Biologics Market Report.
[4] Centers for Medicare & Medicaid Services. (2022). Part B Drug Pricing & Reimbursements.
[5] Bloomberg Intelligence. (2023). Biologics and Biosimilars Market Overview.
