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Last Updated: December 18, 2025

Drug Price Trends for NDC 00904-7377


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Market Analysis and Price Projections for NDC 00904-7377

Last updated: July 28, 2025


Introduction

NDC 00904-7377 corresponds to Mepolizumab, a biologic therapy marketed under the brand name Nucala, developed by GlaxoSmithKline. Approved by the FDA in 2015, Mepolizumab is indicated for eosinophilic asthma, hypereosinophilic syndrome, and certain other eosinophil-driven conditions. This analysis evaluates current market dynamics, competitive landscape, pricing strategies, and future price projections for NDC 00904-7377 within the context of its therapeutic class.


Therapeutic Market Landscape

Mepolizumab belongs to the biologic class targeting eosinophil-driven inflammatory pathways, a segment that has experienced exponential growth due to increased understanding of eosinophilic diseases. The primary competitors include Benralizumab (Fasenra), Dupilumab (Dupixent), and Reslizumab. These drugs serve overlapping indications, with distinct mechanisms of action and dosing schedules.

The global asthma therapeutics market is projected to reach approximately USD 24 billion by 2027, expanding at a CAGR of 4.5% (Grand View Research, 2022). Within this, biologic therapies account for a significant share owing to their targeted efficacy and growing adoption. Specifically, eosinophilic asthma accounts for an estimated 20-30% of asthma cases, representing a sizable niche for Mepolizumab.

In the US, the prevalence of severe eosinophilic asthma is estimated at 100,000–250,000 patients. The increased diagnosis rates, combined with guidelines emphasizing biologics for optimal management, underpin the significant demand. However, market penetration is moderated by factors such as high therapy costs, physician prescribing patterns, and insurance reimbursement frameworks.


Market Penetration and Adoption Trends

Since its launch, Nucala has experienced steady adoption largely driven by robust clinical trial data demonstrating efficacy and safety in eosinophilic conditions. Several pivotal studies, including the DREAM and MENSA trials, established its role as an effective corticosteroid-sparing agent in eosinophilic asthma.

Key market drivers include:

  • Clinical Efficacy: Demonstrated reductions in exacerbation rates and oral corticosteroid dependence.
  • Regulatory Approvals: Expansion of indications, including hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis, broaden the patient pool.
  • Guideline Endorsement: Recommendations from the Global Initiative for Asthma (GINA) and other professional societies enhance prescribing confidence.
  • Reimbursement & Access: Favorable payer coverage, though high treatment costs remain barriers.

Despite these factors, market penetration is tempered by the high cost of biologics, with list prices often exceeding USD 32,000 annually per patient (CMP, 2022). Moreover, competitive therapies with marginally different efficacy profiles influence physician choice strategies.


Pricing Overview

Current Pricing Landscape:

  • List Price: Approximately USD 32,500 – USD 33,000 per year (per dosing regimen), with variations depending on pharmacy discounts and contractual arrangements.
  • Administration: Subcutaneous injection, typically administered every 4 weeks; impacts patient adherence and healthcare resource utilization.
  • Reimbursement Dynamics: Payers often negotiate discounts, with actual transaction prices lower than list prices, influencing net revenues.

Cost Comparison:

Therapy Approximate Annual Cost Indications Dosing Frequency
Mepolizumab (Nucala) USD 32,000 – USD 33,000 Asthma, HES, EGPA Monthly
Benralizumab (Fasenra) USD 31,000 – USD 32,000 Similar; eosinophilic asthma Monthly
Dupilumab (Dupixent) USD 37,000 – USD 40,000 Atopic dermatitis, asthma, nasal polyposis Biweekly/Monthly
Reslizumab USD 27,000 – USD 30,000 Severe eosinophilic asthma Monthly

Note: Variations depend on negotiated contracts, discounts, and regional pricing policies.


Future Price Projections

Projecting the future pricing of NDC 00904-7377 involves multiple factors, including market competition, patent exclusivity, regulatory developments, and healthcare reforms.

1. Patent and Market Exclusivity:

  • GlaxoSmithKline's patent protection and data exclusivity for Mepolizumab are expected to extend until 2027–2029, after which biosimilar or biosimilar-like products could enter the market, exerting downward pressure on prices.

2. Competitive Dynamics:

  • Benralizumab and Reslizumab will continue to challenge Mepolizumab's market share, possibly incentivizing price adjustments to maintain competitiveness.
  • Upcoming biosimilars, approved or in development, are likely to lead to significant price reductions, potentially by 20–40% upon market entry.

3. Price Trends:

  • Historically, biologic prices have decreased gradually post-launch due to increased competition and payer negotiation leverage.
  • Considering these elements, average list prices for NDC 00904-7377 are projected to decline by approximately 10–15% over the next 3–5 years, contingent upon biosimilar entry and market consolidation.

4. Impact of Healthcare Policy:

  • Heightened emphasis on drug affordability and value-based care could catalyze further price erosion.
  • Medicaid and Medicare negotiations may also exert downward pressure, especially in the US.

5. Global Market Considerations:

  • In emerging markets, prices are typically lower due to regulatory policies and economic factors; thus, global average prices might decline more significantly.

Summary of Price Projections:

Timeline Price Estimate Factors Influencing Price
2023–2025 USD 32,000 – USD 34,000 Stable but with slight downward trend
2026–2028 USD 28,800 – USD 30,600 (10–15% reduction) Biosimilar competition, healthcare reforms
2029 and beyond USD 25,600 – USD 27,300 Biosimilar market penetration, negotiated discounts

Regulatory and Policy Outlook

The patent expiry window sets the stage for biosimilar development. Regulatory pathways in the US (FDA biosimilar pathway) and Europe (EMA biosimilar guidelines) facilitate entry but are moderated by high development costs and complex approval processes. The arrival of biosimilars targeting large eosinophilic biologic segments will reshape price dynamics, favoring downward revisions.

Additionally, payer-driven formulary inclusions and access programs will influence actual transaction prices rather than list prices alone.


Key Market Opportunities and Challenges

Opportunities:

  • Expansion into new indications, such as chronic obstructive pulmonary disease (COPD) with eosinophilic phenotype.
  • Development of combination therapies to enhance efficacy.
  • Digital health tools improving adherence and monitoring.

Challenges:

  • High cost limiting access in some markets.
  • Competitive pressure from emerging biosimilars and novel biologics.
  • Prescriber and payer resistance to high-cost biologic therapies.

Conclusion

The current market for NDC 00904-7377, Mepolizumab, remains robust amid significant competition. Price stability at approximately USD 32,000 annually reflects its entrenched position in eosinophilic asthma treatment but is under pressure from biosimilar development and policy shifts. Expect gradual pricing declines aligned with biosimilar market entry, regulatory changes, and healthcare reforms. Stakeholders should monitor patent timelines, competitive landscape, and payer negotiation trends to optimize market strategies.


Key Takeaways

  • Mepolizumab commands high acquisition costs but maintains significant therapeutic demand due to its efficacy in eosinophilic diseases.
  • The biologic market's competitive landscape suggests a moderate downward pricing trajectory over the coming 3–5 years.
  • Biosimilar entry post-2027 could reduce prices by up to 40%, reshaping the market entry point for new competitors.
  • Payer policies and healthcare reforms remain pivotal in determining actual transaction prices and patient access.
  • Continuous monitoring of regulatory developments and market dynamics is essential for strategic decision-making.

FAQs

1. When are biosimilars for Mepolizumab expected to enter the market?
Biosimilar development is already underway, with approvals potentially achievable shortly after patent expiry, anticipated around 2027–2029.

2. How does Mepolizumab’s efficacy compare to competitors?
Clinical trials demonstrate comparable efficacy among eosinophil-targeting biologics, with choice often guided by patient factors, dosing preferences, and reimbursement considerations.

3. What factors influence the pricing of biologics like NDC 00904-7377?
Manufacturing costs, patent status, market competition, payer negotiations, and regulatory policies significantly influence pricing.

4. How can healthcare providers reduce costs while maintaining access?
Providers can leverage patient assistance programs, negotiate with payers, and advocate for formulary placement to improve affordability.

5. What is the impact of healthcare reforms on biologic pricing?
Reforms emphasizing value-based care and cost-effectiveness assessments are likely to impose downward pressure on biologic prices, including Mepolizumab.


Sources:

  1. Grand View Research. (2022). Asthma therapeutics market size, share & trends analysis.
  2. CMP. (2022). Biologic drug pricing reports.
  3. U.S. Food and Drug Administration. (2015). FDA Approval for Nucala.
  4. MarketWatch. (2023). Biologics market outlook and forecasts.

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