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Last Updated: April 1, 2026

Drug Price Trends for NDC 00168-0417


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Best Wholesale Price for NDC 00168-0417

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 00168-0417

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

  • Prevalence of eosinophilic asthma: Estimated at 10-15% of severe asthma cases globally (Global Initiative for Asthma, 2022).

  • Unmet needs: Patients with corticosteroid-resistant asthma or requiring frequent exacerbations.

  • Reimbursement landscape: Insurance coverage varies; Medicaid and private insurers generally favor biologic therapies after failure of standard treatments.

Revenue Trends

  • Steady growth from 2015 to 2022, with compounded annual growth rate (CAGR) estimated at 15-20%.

  • 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

  • Pricing pressure exists from payers seeking biosimilar options to reduce costs.

  • Monoclonal antibody biosimilar approval status: No biosimilars approved as of 2023, maintaining high prices.

  • Patient access improves with expanded insurance coverage, but high costs remain a barrier for some providers and payers.

Price Projection Assumptions

  • Market growth: CAGR maintained at 15% for the next five years based on historical sales data and expanding indications.

  • Pricing stability: Prices will decline marginally (~5%) due to biosimilar pressure by 2025; no biosimilars approved yet.

  • 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.

  • Regulatory changes could impose price caps or reimbursement restrictions.

Opportunities

  • Expanding indications (e.g., eosinophilic granulomatosis with polyangiitis, HES) may open new revenue streams.

  • Expansion into emerging markets could triple sales over the next decade.

Key Takeaways

  • NDC 00168-0417, or Mepolizumab, faces slow but steady growth driven by increasing prevalence of eosinophilic diseases and expanding indications.

  • Prices remain high due to lack of biosimilars and patent exclusivity, but some decline is expected as biosimilar candidates advance.

  • Revenue projections suggest a compound annual growth rate of approximately 15% until 2027, with total sales surpassing $4.5 billion.

  • Market risks include biosimilar competition and evolving treatment options; opportunities lie in new indications and geographic expansion.

FAQs

  1. 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.

  2. 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.

  3. What are the main drivers of market growth?
    Increasing prevalence of eosinophilic conditions, expanded indications, and insurance coverage.

  4. What factors could suppress future revenues?
    Biosimilar competition, curtailment of pricing growth, or regulatory interventions might drive prices down.

  5. 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.

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