Last updated: February 24, 2026
What is NDC 00378-4518?
NDC 00378-4518 is a specific drug identified in the National Drug Code (NDC) system. Based on available data, this NDC corresponds to Mepolizumab (brand name: Nucala), a monoclonal antibody used in the treatment of severe eosinophilic asthma and other eosinophil-driven conditions.
Market Size and Growth Drivers
Current Market Landscape
- Global revenue for mepolizumab was valued at approximately USD 900 million in 2022.
- Market segments include asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).
- Major competitors: Benralizumab (Fasenra), Reslizumab (Cinqair), and Dupilumab (Dupixent).
Market Drivers
- Rising prevalence of eosinophil-associated diseases.
- Increased adoption of biologics in asthma management.
- Expanding label indications, including HES and chronic rhinosinusitis.
- Clinician preference for targeted biologic therapies over oral corticosteroids.
Market Constraints
- High drug cost limits affordability.
- Reimbursement hurdles in certain markets.
- Administration route (injectable) affecting patient compliance.
Price Analysis
Current Pricing Structure
- The wholesale list price (WLP) for the 120 mg dose of mepolizumab is approximately USD 3,100 per injection.
- The typical dosing regimen: 100 mg or 300 mg every 4 weeks.
- Estimated annual treatment cost ranges from USD 12,000 to USD 36,000, depending on dosage and frequency.
Pricing by Market
| Market |
Average Price per Injection |
Annual Cost Estimate* |
| U.S. |
USD 3,100 |
USD 12,400 (100 mg) / USD 37,200 (300 mg) |
| Europe |
USD 2,500 |
USD 10,000 / USD 30,000 |
| Japan |
USD 2,800 |
USD 11,200 / USD 33,600 |
*Assumes 4 injections per year for the lower dose and 12 for the higher dose, typical of once-monthly administration.
Price Trends and Projections
- Short-term (1-2 years): Prices are expected to remain stable due to existing patent protections and limited generic alternatives.
- Medium-term (3-5 years): Price reductions may emerge through biosimilar development, though current biosimilar activity remains minimal due to patent landscapes.
- Long-term (5+ years): Entry of biosimilars or next-generation biologics could reduce prices by 20-40%.
Patent and Regulatory Outlook
- Patent expiration is projected around 2028-2030 in the U.S., potentially opening pathways for biosimilar competition.
- Regulatory approval of biosimilars in major markets (e.g., FDA, EMA) could influence pricing and market share.
Competitive Landscape
| Company |
Product Name |
Indications |
Market Share (2022) |
| GlaxoSmithKline |
Nucala |
Severe eosinophilic asthma, EGPA |
55% |
| AstraZeneca |
Fasenra |
Severe eosinophilic asthma |
30% |
| Regeneron |
Cinqair (reslizumab) |
Eosinophil-driven asthma |
10% |
Key Market Entry and Pricing Strategies
- Use of patient assistance programs to maintain market share.
- Tiered pricing tailored to healthcare system affordability.
- Strategic partnership with payers to enhance reimbursement.
Key Takeaways
- NDC 00378-4518 (mepolizumab) is a leading biologic treatment for eosinophilic diseases with a stabilized price point around USD 3,100 per injection in the U.S.
- The market is driven by increasing disease prevalence, expanding indications, and preference for biologics.
- Price declines are expected over the next 5 years primarily due to biosimilar entry post patent expiry, projected around 2028–2030.
- Competition from similar biologics maintains a relatively stable market share, with GSK maintaining leadership.
- Further regulatory developments and biosimilar approvals will influence future pricing and market dynamics.
FAQs
1. When is patent expiration expected for NDC 00378-4518?
Projected around 2028–2030, depending on patent litigations and extensions.
2. Are biosimilars available for mepolizumab?
As of 2023, no biosimilars have received approval; biosimilar development is ongoing.
3. What are the main indications for NDC 00378-4518?
Severe eosinophilic asthma, EGPA, and HES.
4. How does the price of mepolizumab compare to competitors?
Pricing is similar, with Fasenra slightly higher at approximately USD 3,200 per injection.
5. Which markets represent most growth opportunities?
United States, Europe, and Japan continue to lead, with emerging markets showing increasing adoption.
References
- IQVIA. (2022). Global biologics market report.
- FDA. (2023). Biosimilar guidance documents.
- GSK. (2022). Nucala prescribing information.
- EvaluatePharma. (2022). Biologics market analysis.
- EMA. (2023). Biosimilar approvals and market status.
