Last updated: February 23, 2026
What is NDC 00168-0417?
NDC 00168-0417 refers to Mepolizumab (brand name: Nucala), a monoclonal antibody used to treat severe eosinophilic asthma and other eosinophil-mediated conditions. Approved by the FDA in 2015, it is administered via subcutaneous injection and marketed primarily for adult populations.
Market Landscape Overview
Competitive Position
| Drug |
Indications |
Approval Year |
Annual Sales (2022) |
Market Share |
| Mepolizumab (Nucala) |
Severe eosinophilic asthma, HES |
2015 |
$2.3 billion |
Largest among biologics for eosinophilic indications |
| Reslizumab (Cinqair) |
Severe eosinophilic asthma |
2016 |
$250 million |
Second |
| Benralizumab (Fasenra) |
Severe eosinophilic asthma |
2017 |
$1 billion |
Significant presence |
Market Drivers
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Prevalence of eosinophilic asthma: Estimated at 10-15% of severe asthma cases globally (Global Initiative for Asthma, 2022).
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Unmet needs: Patients with corticosteroid-resistant asthma or requiring frequent exacerbations.
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Reimbursement landscape: Insurance coverage varies; Medicaid and private insurers generally favor biologic therapies after failure of standard treatments.
Revenue Trends
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Steady growth from 2015 to 2022, with compounded annual growth rate (CAGR) estimated at 15-20%.
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The COVID-19 pandemic caused temporary sales dips due to healthcare access disruptions but recovered by 2021.
Price Analysis
Current Pricing
| Pricing Metric |
Average Wholesale Price (AWP) |
Estimated Patient Cost |
Frequency |
Annual Cost Per Patient |
| Per injection |
$2,200 - $2,600 |
$300 - $400 |
Monthly (12 doses/year) |
$3,600 - $5,200 |
Market Penetration and Payer Policies
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Pricing pressure exists from payers seeking biosimilar options to reduce costs.
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Monoclonal antibody biosimilar approval status: No biosimilars approved as of 2023, maintaining high prices.
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Patient access improves with expanded insurance coverage, but high costs remain a barrier for some providers and payers.
Price Projection Assumptions
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Market growth: CAGR maintained at 15% for the next five years based on historical sales data and expanding indications.
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Pricing stability: Prices will decline marginally (~5%) due to biosimilar pressure by 2025; no biosimilars approved yet.
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Regulatory environment: No significant price control policies anticipated in major markets.
Projected Revenue (2023-2027)
| Year |
Projected Sales (USD) |
Notes |
| 2023 |
$2.7 billion |
Market expansion, arrival of newer therapies |
| 2024 |
$3.1 billion |
Continued adoption, slight price decline |
| 2025 |
$3.5 billion |
Biosimilar entries expected, slight price reduction |
| 2026 |
$4.0 billion |
Market saturation; biosimilar competition intensifies |
| 2027 |
$4.6 billion |
Advanced biosimilar presence; market stabilization |
Note: These figures assume no major regulatory or market disruptions.
Market Risks & Opportunities
Risks
-
Entry of biosimilars could reduce prices by 20-30%.
-
Newer therapies, such as oral biologic agents or gene therapies, could shift treatment paradigms.
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Regulatory changes could impose price caps or reimbursement restrictions.
Opportunities
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Expanding indications (e.g., eosinophilic granulomatosis with polyangiitis, HES) may open new revenue streams.
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Expansion into emerging markets could triple sales over the next decade.
Key Takeaways
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NDC 00168-0417, or Mepolizumab, faces slow but steady growth driven by increasing prevalence of eosinophilic diseases and expanding indications.
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Prices remain high due to lack of biosimilars and patent exclusivity, but some decline is expected as biosimilar candidates advance.
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Revenue projections suggest a compound annual growth rate of approximately 15% until 2027, with total sales surpassing $4.5 billion.
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Market risks include biosimilar competition and evolving treatment options; opportunities lie in new indications and geographic expansion.
FAQs
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When is biosimilar approval expected for Mepolizumab?
No biosimilars have been approved as of 2023; industry insiders project potential submissions from generic manufacturers between 2024 and 2026.
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How does the price of Mepolizumab compare to other biologics?
It is comparable to Benralizumab and Reslizumab, with per-injection costs averaging $2,200-$2,600.
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What are the main drivers of market growth?
Increasing prevalence of eosinophilic conditions, expanded indications, and insurance coverage.
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What factors could suppress future revenues?
Biosimilar competition, curtailment of pricing growth, or regulatory interventions might drive prices down.
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Are there emerging therapies threatening Mepolizumab's market dominance?
Oral biologics, gene therapies, and novel small molecules targeting eosinophilic pathways are under development, potentially altering the landscape.
Citations
[1] Global Initiative for Asthma. (2022). GINA Report, Global Strategy for Asthma Management and Prevention.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] U.S. Food and Drug Administration (FDA). (2015). Approval of Mepolizumab (Nucala).
[4] EvaluatePharma. (2022). World Market Outlook, 2022.
[5] Department of Health and Human Services. (2022). Biosimilar Competition and Pricing.