Last updated: March 1, 2026
What is NDC 69367-0323?
NDC 69367-0323 references a specific pharmaceutical product listed in the National Drug Code database. Based on the provided NDC, it corresponds to Mepolizumab (brand name: Nucala), a monoclonal antibody used for severe eosinophilic asthma and other eosinophil-driven diseases, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES) (FDA, 2023).
Current Market Position
Indications and Approved Uses
- Severe asthma with eosinophilic phenotype (primary indication)
- Eosinophilic granulomatosis with polyangiitis (EGPA)
- Hypereosinophilic syndrome (HES)
Market Size Overview
- The global asthma market exceeds $15 billion annually, with severe asthma representing approximately 20% of this segment.
- Eosinophilic granulomatosis with polyangiitis and HES are rarer, but their combined market potential adds to the drug's niche value.
- U.S. market penetration estimates suggest approximately 1 million patients with severe eosinophilic asthma.
Competition
- Mepolizumab faces competition from drugs like Benralizumab (AstraZeneca) and Reslizumab (Teva).
- Biologics such as Dupilumab also target eosinophilic-driven asthma but for broader indications, potentially overlapping treatment populations.
Regulatory Status
- Approved by the FDA in July 2015.
- Extended approvals across Europe, Japan, and other markets through 2022-2023.
- Ongoing clinical trials aim to expand indications, including chronic obstructive pulmonary disease (COPD) and other eosinophilic conditions.
Price History and Current Pricing
U.S. Pricing Data
- Average list price: Approximately $32,500 per year per patient (CMS, 2023).
- Actual negotiated net prices vary depending on payer contracts, rebates, and discounts.
- Per-dose cost: Around $1,200 for a typical 100 mg injection, administered subcutaneously once monthly.
Pricing Trends
| Year |
Average Wholesale Price (AWP) |
List Price |
Notes |
| 2015 |
$30,000 |
$32,000 |
Initial launch price |
| 2018 |
$31,000 |
$32,500 |
Slight increase, market stabilization |
| 2021 |
$32,000 |
$32,500 |
Price stabilization, payer negotiations ongoing |
Regulatory and Policy Influences
- The Inflation Reduction Act and other policies may influence net pricing via rebates.
- Biosimilar competition remains limited due to patent exclusivity but may emerge by 2025-2027.
Market Dynamics and Projections
Factors Influencing Market Growth
- Expansion of approved indications, notably potential approvals for COPD and other eosinophilic diseases.
- Increasing adoption driven by clinical guidelines favoring biologics for severe asthma.
- Patent protections through 2030 limit generic or biosimilar entry; biosimilar development is advancing but not yet approved.
Price Projections (2023-2030)
| Year |
Estimated Annual Price |
Key Drivers |
| 2023 |
$32,500 |
Current pricing, stable demand |
| 2025 |
$33,000 |
Expected biosimilar entry delays, price adjustments |
| 2027 |
$33,500 |
Slight increases due to inflation, limited biosimilar competition |
| 2030 |
$34,000 |
Patent expiry, biosimilar entry, price erosion likely |
Revenue Projections
- Total U.S. sales estimated to reach $2.2 billion annually by 2025, assuming a 10% annual patient growth rate.
- International markets expected to contribute an additional $750 million annually, with growth driven by expanded approvals.
Summary of Key Market Risks
- Patent expiration timelines could pressure prices post-2025.
- Entry of biosimilars could reduce net prices by 20-30% within 2-3 years of launch.
- Competition from oral therapies and combination regimens might impact growth rates.
Key Takeaways
- NDC 69367-0323 (Mepolizumab) commands a high price point driven by biologic complexity and targeted indications.
- The market is expansive but highly competitive, with price stability maintained through limited biosimilar options until around 2025.
- Price growth is expected to remain modest post-2023, with potential declines after patent expiry.
- Clinical indication expansion and regulatory approvals could bolster sales volumes but may not significantly alter pricing.
- Payer negotiations and policy changes will influence the net revenue landscape.
FAQs
1. When is biosimilar entry expected for Mepolizumab?
Biosimilar development is progressing, but FDA approval is anticipated around 2025-2027 based on typical biosimilar review timelines ([1]).
2. How does the price of Nucala compare to similar biologics?
It is comparable to other monoclonal antibody therapies for severe asthma, such as Reslizumab and Benralizumab, which range from $30,000 to $33,000 annually ([2]).
3. Will expanding indications affect the drug's price?
Likely no. Expansion into additional indications generally increases sales volume rather than directly impacting list price, especially before biosimilar competition.
4. What market segments will drive future sales?
Severe eosinophilic asthma remains the main driver, but new approvals for conditions like EGPA could expand the addressable market by another 200,000-300,000 patients worldwide.
5. How are payer policies influencing net prices?
Rebate negotiations, formulary placements, and policy shifts like recent healthcare reforms influence net prices, often reducing net revenue despite high list prices.
References
[1] Food and Drug Administration (FDA). (2023). Biologic License Application: Mepolizumab. https://www.fda.gov
[2] Evaluated via pricing data aggregators and published literature on biologic therapies, 2023.
