Last updated: February 23, 2026
What is the Drug Associated with NDC 51407-0677?
NDC 51407-0677 corresponds to Nucala (mepolizumab), a monoclonal antibody used in the treatment of severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. It is approved by the FDA since 2015 for asthma and received subsequent indicated uses.
Market Size and Dynamics
Industry Overview
- Global allergy immunotherapy market was valued at approximately $8 billion in 2022.
- The asthma biologics segment, including mepolizumab, accounted for roughly 35% of that value.
- Mepolizumab is marketed by GlaxoSmithKline (GSK), competing primarily against other IL-5 inhibitors like Reslizumab (Cinqair) and Benralizumab (Fasenra).
Patient Population and Demand Trends
- Estimated 25 million Americans with asthma.
- About 10-15% have severe eosinophilic asthma, totaling approximately 2.5-3.75 million patients in the U.S.
- Chronic rhinosinusitis with nasal polyps affects 2-4% of the population; approximately 6-12 million Americans.
- Eosinophilic esophagitis constitutes roughly 50,000 cases in the U.S.
Demand drivers:
- Growing confirmation of eosinophilic markers in asthma and related conditions.
- Increasing adoption of biologics in severe cases, driven by guidelines from GINA and AAAAI.
- Commercial expansion into Europe, Asia, and other regions.
Competitive Landscape
| Drug |
Manufacturer |
Indications |
US Launch Year |
Annual Revenue (2022) |
Market Share (Approximate) |
| Mepolizumab (Nucala) |
GSK |
Severe eosinophilic asthma, nasal polyps |
2015 |
$1.3 billion |
40-50% |
| Reslizumab (Cinquair) |
Regeneron |
Severe eosinophilic asthma |
2016 |
$250 million |
15-20% |
| Benralizumab (Fasenra) |
AstraZeneca |
Severe eosinophilic asthma |
2017 |
$1 billion |
40-45% |
Market Share Considerations
- Nucala remains the leading IL-5 inhibitor in the U.S.
- Adoption rates driven by dosing convenience (subcutaneous vs. IV), insurance coverage, and regulatory updates.
- Upcoming biosimilar or alternative therapies could influence long-term share.
Price Trends and Projections
Current Pricing
- List price for Nucala (per 100 mg dose): approximately $4,200.
- Typical maintenance regimen: 100 mg subcutaneously every four weeks.
- Annual treatment cost per patient: ~$50,000.
Reimbursement and Discounts
- Average net price after rebates: ~$30,000–$35,000 annually.
- Pricing strategies include tiered discounts for large insurers and pharmacy benefit managers.
Price Projections (Next 5 Years)
| Year |
Expected List Price per 100 mg Dose |
Notes |
| 2023 |
$4,200 |
Current market rate |
| 2024 |
$4,300 |
Slight increase linked to inflation and R&D costs |
| 2025 |
$4,350 |
Continued inflation adjustments |
| 2026 |
$4,500 |
Potential price hikes aligned with inflation |
| 2027 |
$4,700 |
Incorporation of value-based pricing models |
Note: Actual net prices may vary due to negotiations, discounts, and payer contracts. No significant upcoming patent expirations have been announced for Nucala’s formulation.
Entry of Biosimilars and Impact
- No FDA-approved biosimilar for mepolizumab as of 2023.
- Biosimilar development for similar IL-5 inhibitors could pressure prices after patent expiry (expected beyond 2030).
- Biosimilar entry typically reduces prices by 15-30% over 3-5 years post-launch.
Regulatory and Policy Factors
- The US FDA approved indications have expanded from asthma to include nasal polyps and eosinophilic esophagitis, broadening market access.
- CMS and insurance providers increasingly favor biologic therapies with demonstrated clinical benefit, influencing formulary decisions.
Key Market Outlook Summary
- The sector expects modest annual price growth of 3-5%, aligned with healthcare inflation.
- Market share remains stable for Nucala due to its early entry and established clinical profile.
- Price pressures may emerge from biosimilar competition beyond 2030, but current trends favor continued/gradual increases.
Key Takeaways
- Nucala dominates the IL-5 inhibitor segment in the U.S., with continued growth driven by expanded indications and increasing disease prevalence.
- The current average annual treatment cost is around $50,000 per patient.
- Price increases are expected to stay within general healthcare inflation rates unless new competitors or regulatory policies alter the landscape.
- No biosimilars are available yet, but their emergence could significantly impact prices post-2030.
- A sustained focus on clinical outcomes may justify incremental pricing adjustments.
FAQs
Q1: What is the expected patent expiration date for Nucala?
There is no public patent expiry date; however, most patents are likely to expire beyond 2030, considering key patents were filed around 2013-2014.
Q2: Will biosimilars likely reduce Nucala’s price?
Potentially. Biosimilar entry could lower prices by 15-30% depending on market competition and regulatory approval timing.
Q3: How does Nucala’s costs compare internationally?
Prices in Europe and Canada tend to be 20-30% lower due to negotiated reimbursement agreements, affecting global market profitability.
Q4: What factors could influence future demand for Nucala?
Emerging evidence on eosinophil-driven diseases, expanded indications, and potential therapeutic alternatives.
Q5: Are there any significant legal or regulatory threats?
No current significant legal challenges or regulatory barriers threaten Nucala’s market position as of 2023.
Sources:
[1] IQVIA, "Pharmaceutical Market Data," 2022.
[2] U.S. Food & Drug Administration. "Nucala (mepolizumab) Approval History," 2015–2023.
[3] EvaluatePharma. "Biologic Drug Market Analysis," 2022.
[4] GSK Corporate Reports, "Annual Financial & Market Reports," 2022.
[5] FDA. "Biosimilar Development and Approval," 2023.
