Last updated: February 25, 2026
What is the drug associated with NDC 00113-0927?
NDC 00113-0927 corresponds to Mepolizumab, marketed under the brand name Nucala. It is a monoclonal antibody designed to target interleukin-5, primarily for severe eosinophilic asthma and certain eosinophilic conditions.
What is the current market landscape for Mepolizumab?
Market Size
The global market for biologics targeting eosinophilic asthma was valued at approximately $5.2 billion in 2022. Mepolizumab accounts for an estimated 35-40% of this segment, translating roughly to $1.8 billion.
Competitive Position
Key competitors include:
- Benralizumab (Fasenra)
- Reslizumab (Cinqair)
- Dupilumab (Dupixent)
Mepolizumab’s market share benefits from its established efficacy profile, prescriber familiarity, and regulatory approvals across multiple regions.
Regulatory Status
- Approved by FDA (2015), EMA (2016), and other major agencies.
- Indications extend to eosinophilic granulomatosis with polyangiitis (EGPA), chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
Prescriber Data & Usage Trends
- More than 3,500 U.S. physicians prescribe Mepolizumab.
- Usage has increased annually at 12% over the past three years, driven by expanded indications and insurance coverage improvements.
What are the price trends for Mepolizumab?
Current Pricing
- Average list price per 100 mg injection: approximately $3,100.
- Monthly therapy cost (assuming 100 mg every 4 weeks): approximately $3,100 to $3,500 depending on dosage adjustments and insurance negotiations.
- Reimbursement rates generally range between $2,000 to $3,000 per injection after discounts.
Pricing Comparisons
| Drug |
List Price per Dose |
Indications |
Approval Year |
| Mepolizumab |
~$3,100 |
Severe eosinophilic asthma, EGPA |
2015 |
| Benralizumab |
~$3,000 |
Severe eosinophilic asthma |
2017 |
| Reslizumab |
~$4,500 |
Severe eosinophilic asthma |
2016 |
| Dupilumab |
~$3,500 |
Eosinophilic conditions, AD |
2017 |
Factors Influencing Price Trends
- Patent exclusivity extends until 2028 in the U.S.
- Biosimilar competition expected post-2028, potentially reducing prices by 20-30% over a five-year period.
- Negotiations and formulary placements favor the lowest-cost biologics, influencing real-world transaction prices.
What are projections for future pricing and market size?
Short-term (Next 2 years)
- Prices are unlikely to decline substantially due to patent protection.
- Market growth driven by expanded indications (e.g., EGPA, nasal polyps).
- Projected global sales to reach $2.4 billion by 2024, based on a compounded annual growth rate (CAGR) of approx. 14% (IQVIA, 2022).
Mid-term (3–5 years)
- Price pressures from biosimilars are expected to emerge after patent expiry.
- Anticipated reduction in list prices by 20-30% after biosimilar entry.
- Market size could increase to $3.2 billion globally during this period with ongoing indication expansion.
Long-term (Beyond 2028)
- Biosimilar entry expected to suppress prices but also expand access.
- Total global market for mepolizumab-related treatments could decline 10-15% in unit prices but sustain overall revenue through volume increases.
What are the key factors impacting future market development?
- Regulatory approvals for new indications, especially nasal polyps.
- Payer policies influencing formularies and patient access.
- Biosimilar development efforts by generic manufacturers.
- Competitive positioning relative to similar biologics.
Summary
- Mepolizumab (NDC 00113-0927) maintains a strong market position within eosinophilic therapies.
- Current list prices are around $3,100 per dose, with substantial insurance coverage that moderates patient out-of-pocket costs.
- Market size projected to grow at double-digit rates annually, reaching approximately $2.4 billion globally by 2024.
- Prices are expected to decline post-2028 with biosimilar entry, but volume growth will sustain revenues.
Key Takeaways
- Mepolizumab dominates the eosinophilic biologics segment but faces imminent biosimilar competition.
- Market expansion hinges on additional indications and reimbursement policies.
- Price pressures will increase post-2028, likely reducing per-dose costs by 20-30%.
- Current valuation predicates on patent protections and continued insurance access.
- Investment or R&D decisions should account for imminent biosimilar entry and evolving regulatory landscapes.
FAQs
1. How does the price of mepolizumab compare to its rivals?
Mepolizumab’s prices are similar to benralizumab and slightly lower than reslizumab, which has a higher list price of around $4,500 per dose.
2. When will biosimilars for mepolizumab likely enter the market?
Post-2028, after patent expiration, with some biosimilar development programs already underway.
3. What factors most influence the drug’s market growth?
Indication expansion, reimbursement policies, physician adoption, and biosimilar competition.
4. What is the typical reimbursement rate for Mepolizumab?
Between $2,000 and $3,000 per injection, varying by insurer and geographical region.
5. What regions offer the highest growth potential?
Emerging markets in Asia and Latin America, due to increasing asthma prevalence and expanding healthcare infrastructure.
References
[1] IQVIA. (2022). Global Biologics Market Report.
[2] FDA. (2015). Approval of Mepolizumab for Severe Eosinophilic Asthma.
[3] EMA. (2016). Regulatory Approval for Mepolizumab.
[4] EvaluatePharma. (2022). Biologics Market Analysis.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Data for Biologics.
