Last updated: February 22, 2026
What Is NDC 69489-0411?
NDC 69489-0411 refers to a specific pharmaceutical product registered with the National Drug Code. This NDC is associated with Mepolizumab, a monoclonal antibody used for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) and severe eosinophilic asthma.
Market Overview
Therapeutic Area and Indications
Mepolizumab addresses two high-prescription markets:
- Severe eosinophilic asthma: Approved since 2015, it targets patients inadequately controlled with existing therapies.
- EGPA: Approved in 2017, expanding market potential within rare disease treatment.
Market Size and Growth
- Global asthma market: Valued at USD 13.2 billion in 2020, with an expected compound annual growth rate (CAGR) of ~4% until 2027 [1].
- Eosinophilic asthma segment: Estimated at USD 3–4 billion, with increased adoption of biologics driving growth.
- EGPA market: Smaller, niche, with fewer annual cases (~2,500 globally), but high-cost treatment per patient.
Key Competitors
| Drug Name |
Market Share |
Price (per dose) |
Approval Year |
Indications |
| Mepolizumab |
Leading |
USD 3,000–3,500 |
2015 |
Asthma, EGPA |
| Benralizumab |
Competitive |
USD 3,000–3,400 |
2017 |
Asthma |
| Reslizumab |
Niche |
USD 4,000–4,400 |
2016 |
Severe eosinophilic asthma |
Note: Prices vary by manufacturer, distribution, and insurer negotiations.
Price Projections
Current Pricing Trends
- Average wholesale price (AWP): Approximately USD 3,000–3,500 per dose.
- Per-episode cost: For typical dosing regimens (e.g., once monthly), annual treatment costs range from USD 36,000 to USD 42,000 per patient.
Future Price Dynamics
- Patent protections for originator biologics like mepolizumab are scheduled to expire in the late 2020s, opening markets for biosimilars.
- Biosimilar entry: Expected to decrease prices by 20–40%, potentially lowering annual treatment costs to USD 20,000–30,000 per patient.
- Pricing pressure factors:
- Insurance and payer negotiations
- Expansion of biosimilar manufacturers
- Global market penetration, especially in emerging economies
Cost Reduction Drivers
- Biosimilar competition can lead to a price decrease of 25% within 3 years of biosimilar approval.
- Increased use in moderate cases, expanding eligible patient pool, could impact volume and pricing strategies.
Market Entry Considerations
- Regulatory landscape: Biosimilar approval pathways differ globally; U.S. FDA approval for biosimilars relies on demonstrating biosimilarity, which is expected soon, with biosimilars anticipated by the mid-2020s.
- Reimbursement policies: Variability across countries; strong payer negotiations influence retail prices.
- Manufacturing costs: High due to complex biologic production, impacting biosimilar pricing strategies.
Summary of Price Evaluation
| Time Horizon |
Expected Price Range |
Factors Impacting Price |
| Short-term (1–2 years) |
USD 3,000–3,500 per dose |
Current market, limited biosimilar presence |
| Mid-term (3–5 years) |
USD 2,000–3,000 per dose |
Biosimilar entry, increased competition |
| Long-term (5+ years) |
USD 1,500–2,500 per dose |
Biosimilar prevalence, global adoption |
Key Takeaways
- NDC 69489-0411 (mepolizumab) occupies a high-growth niche within biologic therapies for eosinophilic conditions.
- The current price per dose hovers around USD 3,000–3,500.
- Biosimilar competition is poised to significantly reduce costs, with potential prices declining by approximately 25–50% over the next 5 years.
- Market expansion, particularly in emerging markets, may sustain demand and influence pricing trends.
FAQs
1. When can biosimilars for mepolizumab be expected?
Biosimilar approval is anticipated in the U.S. by the mid-2020s, following biosimilar approval pathways established by the FDA.
2. How does the pricing of mepolizumab compare globally?
Prices vary widely; in Europe, prices are generally 15–25% lower than in the U.S. due to different regulatory environments and negotiation power.
3. What factors influence the uptake of biosimilars?
Regulatory approval, payer acceptance, physician prescribing habits, and manufacturing costs.
4. How does mepolizumab’s pricing impact hospital and payer budgets?
High per-dose costs strain budgets, prompting negotiations and formulary management to control expenses.
5. What are the main barriers to price reductions in the biologic market?
Manufacturing complexity, patent protections, and limited biosimilar market penetration delay significant price decreases.
References
[1] GlobalData. (2021). "Asthma Market Analysis and Forecast."
[2] IQVIA. (2022). "Biologic Pricing Trends."
[3] FDA. (2021). "Biosimilar Regulatory Framework."
[4] reports.merckgroup.com. (2022). "Biologics and Biosimilars Price Outlook."
