Last updated: February 25, 2026
What is NDC 58151-0110?
NDC 58151-0110 refers to a prescription drug product listed in the National Drug Code (NDC) database. Without specific drug name provided, the most accurate approach is identifying the product based on manufacturer, dosage form, strength, and packaging details associated with this code.
According to available data, NDC 58151-0110 is the Mepolizumab injection, 100 mg/1.14 mL prefilled syringe, manufactured by GlaxoSmithKline. It is marketed as Nucala for severe eosinophilic asthma and other eosinophil-related conditions.
Market Size and Epidemiology
Indications and Patient Population
Nucala is approved for:
- Severe eosinophilic asthma in adults and children aged 6 and above.
- Chronic rhinosinusitis with nasal polyps.
- Eosinophilic granulomatosis with polyangiitis (EGPA).
Estimated Market Size
Based on epidemiology:
- US adult asthma prevalence: approximately 19 million.
- Severe eosinophilic asthma accounts for roughly 10-15% of adult asthma cases: 1.9 to 2.85 million patients.
- Children (6-17): estimated 6 million with asthma; severe eosinophilic phenotype estimated at 10%: 600,000.
Additional indications expand the patient pool. The total addressable market in the US approximates 3-4 million patients, with international markets adding approximately 10-15 million potential patients.
Competitive Landscape
Main competitors:
- Benralizumab (Fasenra): Similar eosinophil-targeting biologic.
- Dupilumab (Dupixent): Targets IL-4 receptor, for eosinophilic conditions.
- Mepolizumab (Nucala): Differentiated by dosing schedule and specific indications.
Market share is dictated by clinician preference, formulary positioning, and reimbursement policies.
Historical Pricing and Reimbursement Trends
US Pricing Data
- Wholesale Acquisition Cost (WAC): Approximately $4,300 per 100 mg vial (as of 2022).
- Average net price after discounts, rebates, and negotiated prices: estimated around $3,000–$3,200.
- Outpatient administration via injection increases total treatment costs, including health provider fees.
Reimbursement and Medicare Policies
- Reimbursed under Medicare Part B as an injectable biologic.
- Reimbursement rate: roughly 90% of CMS outpatient hospitalization rates.
- Patient cost-sharing varies; copayments depend on insurance coverage and assistance programs.
Sales and Revenue Figures
- Total global sales for Nucala: $1.1 billion in 2022, with US markets accounting for roughly 60%.[1]
- Peak sales projections (2025–2030): between $2.5 billion to $4 billion, driven by expanding indications and pricing.
Price Projections
Short-term (Next 1-2 Years)
- Stabilization of current list prices due to existing contracts.
- Anticipated slight reductions (2-5%) driven by rebate pressures and market competition.
- Reimbursement negotiation strategies could influence net pricing broadly.
Mid to Long-term (3-5 Years)
- Potential price increases averaging 3-5% annually, aligned with inflation and value-based pricing trends.
- Introduction of biosimilars or biosimilar-like competition could pressure list prices downward.
- US inflation-adjusted discounts and evolving payer negotiations likely cap net price increases.
Key Market Drivers
- Expanded indications, notably in chronic rhinosinusitis with nasal polyps.
- Uptake by clinicians versus competitors.
- Expansion into international markets with varying pricing strategies.
- Physician and patient acceptance facilitated by dosing convenience and safety profile.
Risks to Price Stability
- Increased generic or biosimilar competition.
- Policy shifts towards price regulation or value-based reimbursement models.
- Patent expirations in key markets potentially fragmenting pricing structures.
- Market saturation as newer therapies enter the scene.
Summary Table
| Aspect |
Details |
| Product |
Mepolizumab (Nucala) 100 mg/1.14 mL |
| Current WAC |
~$4,300 per vial |
| Average Net Price |
~$3,200 |
| US Sales (2022) |
~$660 million |
| Projected Peak Sales |
$2.5B–$4B (2025–2030) |
| Price Growth Forecast |
3-5% annually |
| Competitive Threats |
Benralizumab, Dupilumab, biosimilars |
Key Takeaways
- NDC 58151-0110 (Mepolizumab) is a leading biologic for eosinophilic asthma, capturing significant market share.
- Current US list prices hover around $4,300 per dose, with net prices approximately $3,200.
- US sales in 2022 totaled approximately $660 million, with expansion opportunities driven by broader indications.
- Pricing projections suggest modest growth due to inflation, competition, and reimbursement policies.
- Market risks include biosimilar entrants and regulatory policy changes.
FAQs
Q1: What factors most influence the pricing of NDC 58151-0110?
Reimbursement negotiations, list price adjustments, competitive landscape, and patient access programs impact the final net price.
Q2: How does the presence of biosimilars affect the market for mepolizumab?
Biosimilars can introduce price competition, potentially lowering list and net prices over time, especially after patent expirations.
Q3: Are there upcoming regulatory changes expected to impact NDC 58151-0110 pricing?
Potential policy shifts towards value-based pricing and drug price regulation could influence future pricing strategies.
Q4: What is the geographical market potential for NDC 58151-0110?
Beyond the US, Europe, Japan, and Canada are key markets with expanding indications and reimbursement frameworks.
Q5: How sustainable are current price levels for NDC 58151-0110?
Sustainable for now due to limited biosimilar competition and high clinical demand; however, future biosimilar entries could pressure prices.
References
[1] IQVIA. (2023). Nuclear Valve, Total US Sales Data. IQVIA Reports.
