Last updated: February 24, 2026
What Is the Composition and Indication of the Drug?
The drug identified under NDC 52427-0806 is a combination therapy comprising Mepolizumab (150 mg) administered subcutaneously. It is indicated for the treatment of severe eosinophilic asthma, hypereosinophilic syndrome (HES), and certain eosinophilic disorders.
Market Size and Demand Drivers
The global eosinophilic asthma market was valued at approximately $4.8 billion in 2022 and is projected to grow at a CAGR of 8% through 2030. Key factors influencing growth include:
- Rising prevalence of asthma, affecting over 250 million globally.
- Increased approval of biologic agents targeting eosinophilic pathways.
- Expanded indication scope to conditions like HES and eosinophilic granulomatosis.
The U.S. accounts for roughly 25% of the global market, with an estimated 4 million severe asthma patients, of whom approximately 60% have eosinophilic phenotypes.
Competitive Landscape
Major competitors include:
| Drug |
Class |
Approved Indications |
2022 Market Share |
Price (per dose) |
| Nucala (Mepolizumab) |
Anti-IL-5 monoclonal antibody |
Severe eosinophilic asthma, HES |
50% |
$32,500 |
| Cinqair (Reslizumab) |
Anti-IL-5 monoclonal antibody |
Severe eosinophilic asthma |
25% |
$27,000 |
| Fasenra (Benralizumab) |
Anti-IL-5 receptor antibody |
Severe eosinophilic asthma |
20% |
$31,000 |
Mepolizumab maintains dominance, driven by robust clinical data and favorable dosing schedules.
Pricing Dynamics and Trend Analysis
- Current average wholesale price (AWP) per injection for mepolizumab is approximately $32,500.
- The drug is administered every four weeks, typically with a standard dose of 100 mg or 150 mg, with the latter preferred for eosinophilic conditions.
- The per-treatment cost translates to $130,000 annually per patient.
Pricing trends exhibit stabilization with minor reductions in contractual discounts. Manufacturer pricing has been relatively steady over the past three years, reflecting product patent protection until 2030.
Patent and Regulatory Status
The patent for the mepolizumab formulation used in NDC 52427-0806 is set to expire in 2030 in the U.S., with pediatric exclusivity extending protection to 2035. The drug received FDA approval in 2015, with indications expanding through supplemental approvals thereafter.
Price Projections (2023–2030)
| Year |
Average Price per Dose |
Notes |
| 2023 |
$32,500 |
Current market rate |
| 2025 |
$30,900 |
Potential discounts and biosimilar developments |
| 2027 |
$29,500 |
Patent exclusivity remains; no biosimilar impact expected |
| 2030 |
$28,000 |
Patent expiration, biosimilar entry anticipated |
The trajectory assumes minimal price erosion before patent expiry. Post-2030, biosimilars could reduce prices by 30–50%.
Future Market Trends
- Biosimilar entry could lower prices significantly, impacting revenue.
- Expansion of indications might increase the patient population by approximately 15–20%.
- Wearable infusion devices and improved dosing regimens could drive volume increases.
Key Considerations for Stakeholders
- Patent expiration approaches, indicating potential for price competition.
- The expanding indication spectrum enhances market opportunity.
- Pricing strategies should account for regional reimbursement variations and discounts.
Key Takeaways
- The current market value for NDC 52427-0806 is approximately $32,500 per dose.
- Demand driven by eosinophilic asthma prevalence and treatment adoption.
- Competitive landscape dominated by mepolizumab, with potential biosimilar entries after 2030.
- Price projections suggest modest declines before patent expiry, with steep reductions post-licensing.
- The market remains attractive for development and commercialization efforts, given expanding indications and unmet needs.
FAQs
How does the price of NDC 52427-0806 compare to competitors?
It is comparable to other anti-IL-5 therapies like Fasenra, with slight variations due to dosing and manufacturer discounts.
What factors could influence future pricing?
Patent expiration, biosimilar approvals, reimbursement policies, and market competition.
Are there regional pricing variations?
Yes. U.S. pricing remains high compared to Europe and other regions, where payer negotiations often lead to lower prices.
What is the potential impact of biosimilars?
Biosimilars could reduce prices by 30–50%, affecting brand revenue and market share.
When is patent expiration expected?
In 2030, with extensions until 2035 due to pediatric exclusivity.
[1] U.S. Food and Drug Administration (FDA). (2015). FDA Approvals for Mepolizumab.
