Last updated: March 13, 2026
What is NDC 00781-2859?
NDC 00781-2859 refers to Mepolizumab, marketed under the brand name Nucala. It is a monoclonal antibody used to treat severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. Approved by the FDA in 2015, it is administered via subcutaneous injection.
Market Size and Demand Drivers
Global and U.S. Market Size
- The global market for biologics targeting eosinophilic conditions was valued at approximately $5 billion in 2021.
- The U.S. accounts for about 40-50% of this market, estimated at $2-2.5 billion.
- The number of diagnosed eosinophilic asthma patients in the U.S. exceeds 300,000, with around 60-70% eligible for biologics like Mepolizumab based on eosinophil levels.
Key Demand Factors
- Increasing prevalence of severe asthma, estimated to grow at 3-4% annually.
- Expansion of indications, including chronic rhinosinusitis with nasal polyposis (CRSwNP), approved in 2019, broadens target patient base.
- Rising awareness and diagnostic capabilities for eosinophilic disorders.
- Adoption of biologics over corticosteroids and other traditional therapies due to efficacy and safety profiles.
Competitive Landscape
Major competitors include:
| Drug Name |
Manufacturer |
Indications |
Market Share (Estimated) |
Approval Year |
| Mepolizumab (Nucala) |
GlaxoSmithKline |
Asthma, EGPA, HES, CRSwNP |
50-60% |
2015 |
| Benralizumab (Fasenra) |
AstraZeneca |
Severe eosinophilic asthma |
20-25% |
2017 |
| Reslizumab (Cinqair) |
Regeneron |
Severe eosinophilic asthma |
10-15% |
2016 |
Nucala maintains market leadership due to higher indication breadth and established dosing protocols.
Pricing Overview
Current List Prices
- U.S. average wholesale price (AWP): $4,300 - $4,600 per single-dose vial.
- Typical weekly dosing: 100 mg subcutaneous injection, approximately $4,400 per dose.
- Annual treatment cost: roughly $225,000 - $240,000 per patient.
Reimbursement and Price Trends
- Payers negotiate discounts ranging from 10-30%, reducing net prices.
- Rebates and patient assistance programs lower effective expenditure.
- Payer resistance to high-cost biologics influences formulary placements and pricing strategies.
Price Trends (2021-2023)
- Slight reductions due to increased competition and biosimilar considerations.
- No biosimilars available as of Q1 2023; price stability predominates.
- Price adjustments primarily tied to negotiations and healthcare policy changes.
Price Projection Outlook (Next 3-5 Years)
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2023 |
$4,300 - $4,600 |
Stable, with potential minor discounts |
| 2024 |
$4,200 - $4,600 |
Slight decrease expected due to payer negotiations |
| 2025 |
$4,100 - $4,500 |
Continued pressure to reduce costs; no biosalis present, limiting sharp drops |
| 2026 |
$4,000 - $4,400 |
Potential for further price stabilization; value-based contracts may influence effective prices |
Factors Influencing Price Movements
- Biosimilar development or approval could reduce list prices.
- Payer policies and insurance coverage tightly regulate actual patient costs.
- New indications or expanded labeling could sustain or increase prices.
- Patent expirations are not imminent; exclusivity extends into the late 2020s.
Regulatory and Policy Implications
- Patent protections extend into 2027-2029, delaying biosimilar entry.
- Ongoing pressure for value-based pricing and outcomes-based contracts.
- Potential for government negotiations under programs such as the Medicare Drug Price Negotiation Act.
Key Takeaways
- NDC 00781-2859 (Mepolizumab) commands a high list price with limited variability.
- Market demand driven by increasing prevalence and expanded indications.
- Competition from Fasenra and Cinqair captures significant market share.
- Biologics pricing remains stable with minimal reductions expected before biosimilar entry.
- Future price declines depend on biosimilar development, policy changes, and payer strategies.
FAQs
Q1: How does the price of NDC 00781-2859 compare to similar biologics?
It is typically priced slightly higher than Fasenra but comparable to Cinqair, primarily due to differences in indication breadth and dosing.
Q2: Are biosimilars expected to significantly impact prices?
Not before 2027, as patent exclusivity persists. Once biosimilars enter, price reductions could reach 20-30%.
Q3: What factors could lead to higher prices for NDC 00781-2859?
Additional approved indications, scarcity of effective alternatives, or new delivery methods.
Q4: How are payers managing high biologic costs?
Through formulary restrictions, negotiated discounts, and outcome-based payment models.
Q5: What is the outlook for patient access to Mepolizumab?
Coverage remains strong, but high out-of-pocket costs may limit access unless discount programs or assistance are used.
References
[1] IQVIA. (2022). Global biologics market report.
[2] Blue Cross Blue Shield. (2022). Biologic drug formulary guidelines.
[3] U.S. Food and Drug Administration. (2015). Approved drugs: Nucala.
[4] MarketWatch. (2022). Biologics pricing and reimbursement analysis.
[5] Patents and Exclusivity Data. (2023). Patent status for Mepolizumab.
