Last updated: February 21, 2026
What is the Drug with NDC 58657-0160?
The National Drug Code (NDC) 58657-0160 corresponds to a specific pharmaceutical product. Based on available data, this code indicates Mepolizumab (brand name Nucala), a monoclonal antibody used for severe eosinophilic asthma and related eosinophilic conditions.
Market Landscape Overview
Indications and Patient Population
- Primary use: Treatment of severe eosinophilic asthma, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis.
- Patient count estimate: Approximately 400,000 to 600,000 eligible patients in the U.S., based on prevalence data (CDC, 2022).
Competitive Environment
- Key competitors include biologics like Benralizumab (Fasenra) and Reslizumab (Cinqair).
- Mepolizumab holds approximately 50% market share in eosinophilic asthma biologic treatments (IQVIA, 2022).
Market Drivers
- Increasing prevalence of eosinophilic asthma.
- Broader label expansion for related eosinophilic conditions.
- Approval for pediatric use in patients aged 6 and older (FDA, 2019).
Market Challenges
- High treatment costs (~$32,500 annually).
- Requirement for subcutaneous injections every 4 weeks.
- Competition from biosimilars not yet established but expected.
- Pricing pressures from payers and value-based reimbursement models.
Sales and Revenue Trends
| Year |
Estimated US Sales (USD millions) |
Growth Rate |
Notes |
| 2020 |
920 |
- |
Launch year, initial uptake |
| 2021 |
1,150 |
25% |
Growing adoption, expanded indications |
| 2022 |
1,350 |
17% |
Increased market penetration |
| 2023 |
1,500 |
11% |
Stabilized growth, competitive pressures |
(Note: Data derived from IQVIA, company reports)
Price Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): Approximately $32,500 per year for the primary indication.
- Actual reimbursement may be lower due to discounts, rebates, and negotiated contracts.
Short-term (2024-2026)
- Expected to remain stable at WAC levels, with minor fluctuations due to inflation and payer negotiations.
- Payer pressure may lead to net prices around 20% lower than WAC.
Long-term (2027 and beyond)
- Potential for price erosion driven by biosimilar entry, with anticipated reductions of 15-25% over the next 5 years.
- Increased adoption of value-based pricing could influence net prices.
Impact of Biosimilars
- Biosimilar versions of mepolizumab are in early development stages.
- Entry expected within 3-5 years, which could substantially reduce prices.
- Market share likely to fragment, leading to lower overall pricing.
Regulatory and Policy Factors
- FDA maintains strict stability and interchangeability criteria for biosimilars.
- CMS and private payers increasingly favor biosimilar use, pressuring originator prices.
- 2022 legislation promotes biosimilar proliferation, fostering competitive dynamics.
Market Entry and Development Opportunities
- Expanded indications in eosinophilic disorders.
- Off-label uses in other inflammatory diseases.
- Cost-saving biosimilars could enhance access and payor acceptance.
Key Takeaways
- The NDC 58657-0160 (mepolizumab) is a leading biologic for eosinophilic asthma.
- Market growth is driven by increased patient awareness and new indications.
- Current WAC prices are around $32,500 annually; long-term prices may decline 15-25% due to biosimilar competition.
- Revenue growth is slowing but remains steady through 2026, with upside potential from expanded labels.
- Payer negotiations, biosimilar entry, and policy shifts will influence future prices and market share.
FAQs
1. What factors influence mepolizumab’s market share?
Efficacy, safety profile, pricing strategies, biosimilar development, and payer coverage influence its market share.
2. When are biosimilars for mepolizumab expected?
Biosimilars are in early development, with approval anticipated within 3-5 years (2026-2028).
3. How does pricing compare to similar biologics?
The annual cost (~$32,500) aligns with other biologics treating asthma and eosinophilic conditions, such as benralizumab and reslizumab, which range between $30,000-$35,000.
4. What are the main regulatory hurdles?
Biosimilar approval requires demonstrating similarity in safety, purity, and potency; interchangeability status can influence substitution policies.
5. How might future policies impact pricing?
Increased biosimilar utilization and value-based payer models will likely put continued downward pressure on prices.
References
- CDC. (2022). Asthma prevalence. https://www.cdc.gov/asthma/industry.htm
- IQVIA. (2022). Biologic market analysis.
- FDA. (2019). FDA approves Nucala to treat eosinophilic asthma. https://www.fda.gov
- Company Reports. (2022). Mepolizumab sales data and forecasts.
