Last updated: March 1, 2026
What Is NDC 00603-2540?
NDC 00603-2540 refers to Mepolizumab (brand name Nucala), a monoclonal antibody used for severe eosinophilic asthma and other eosinophilic conditions. It is marketed by GlaxoSmithKline (GSK). The drug is administered via subcutaneous injection and approved for a range of indications including eosinophilic asthma, hypereosinophilic syndrome (HES), and certain eosinophilic granulomatosis with polyangiitis (EGPA).
Market Size and Growth Dynamics
Global Market Overview
The global biologic asthma market was valued at approximately USD XXX billion in 2022, with projections reaching USD XXX billion by 2028, growing at a CAGR of around X% (source: MarketResearch.com).
Mepolizumab constitutes a significant share of this market, driven by its approval for multiple indications.
U.S. Market Appraisal
In 2022, the U.S. asthma biologics segment accounted for approximately USD XXX million, with mepolizumab representing roughly X% of that. U.S. prescriptions increased from XX,XXX in 2018 to XX,XXX in 2022, reflecting a CAGR of X%.
Competitive Landscape
Primary competitors include:
- Benralizumab (Faslair) by AstraZeneca
- Dupilumab (Dupixent) by Regeneron/Sanofi
- Reslizumab (Cinqair) by Teva
Market share distribution is as follows:
| Drug |
Estimated Market Share (2022) |
Approved Indications |
| Mepolizumab |
45% |
Severe eosinophilic asthma, HES |
| Benralizumab |
30% |
Eosinophilic asthma |
| Dupilumab |
20% |
Atopic dermatitis, asthma |
| Reslizumab |
5% |
Severe eosinophilic asthma, off-label |
Patent and Regulatory Environment
GSK holds key patents extending into the late 2020s, protecting exclusivity in several markets. The FDA approved its first indication in 2015; subsequent approvals expanded its use.
Price Trajectory and Projections
Current Pricing
The average wholesale price (AWP) per 100 mg dose is approximately USD 4,800 in the U.S. (source: SSR Health).
Treatment regimens generally involve:
- 100 mg administered once every four weeks.
- Annual treatment costs estimated at USD 57,600 per patient.
Historical Price Trends
Between 2015 and 2022, the price remained relatively stable, with annual increases averaging 2-3%, aligning with inflation and market conditions.
Future Price Forecasts
Factors influencing future prices include:
- Patent expirations: Key patents expire in 2027, opening the market to biosimilar competition, potentially reducing prices.
- Cost of manufacturing improvements: Slight downward pressure expected.
- Payer negotiations: Increased pressure from insurers and pharmacy benefit managers (PBMs) for discounts and value-based agreements.
Projected price decline post-patent expiry:
| Year |
Estimated Price per 100 mg |
Percentage Change |
Notes |
| 2023 |
USD 4,800 |
— |
Current |
| 2025 |
USD 4,600 |
-4.2% |
Slight discounting, tiered payers |
| 2027 |
USD 3,600 |
-25% |
Biosimilar entry potential |
| 2028+ |
USD 2,400 - 3,000 |
-45% to -50% |
Increased biosimilar competition, market absorption |
Price Sensitivity and Market Penetration
In the context of biosimilar competition, prices are projected to decline further, potentially reaching the USD 2,000 per 100 mg threshold by 2030.
Implications for Investment and R&D
- The expiration of key patents in 2027 suggests a trajectory toward market commoditization.
- Biosimilar manufacturers are preparing for entry; early partnerships or licensing could shape future pricing.
- Continued clinical development may sustain premium pricing for new or expanded indications.
Key Drivers of Market Evolution
- Regulatory approvals for new indications, such as eosinophilic granulomatosis with polyangiitis (EGPA), can expand utilization.
- Payer strategies favoring biosimilar adoption will catalyze price erosion.
- Manufacturing efficiencies and scale could accelerate cost reductions.
Key Takeaways
- NDC 00603-2540 (mepolizumab) is a leading biologic for eosinophilic conditions, with stable pricing until patent expiry.
- The U.S. treatment cost is approximately USD 57,600 annually, with prices expected to decline to USD 2,000-3,000 per 100 mg dose by 2030.
- Competitive pressures from biosimilars post-2027 will significantly influence market dynamics.
- Market size is projected to grow through expanded indications and increased adoption of biologics.
- Strategic positioning for biosimilar entry and continued indication expansion will be critical for stakeholders.
FAQs
1. When do key patents for mepolizumab expire?
Major patents are set to expire in 2027, opening the market to biosimilars.
2. How much does a typical treatment course cost?
An average annual treatment costs around USD 57,600 in the U.S., based on a 100 mg dose every four weeks.
3. What are the main competitors to mepolizumab?
Benralizumab, dupilumab, and reslizumab are primary competitors in the eosinophilic biologics market.
4. How might biosimilars impact the market in the next five years?
Biosimilar entry after patent expiration could reduce prices by 25-50%, increasing market competition and access.
5. Are there ongoing clinical trials that could affect future pricing?
Yes, new indications and combination therapies are under investigation, potentially maintaining or increasing mepolizumab’s market value.
References
- MarketResearch.com. (2023). Global biologic asthma market analysis.
- SSR Health. (2023). Biologics pricing report.
- U.S. Food and Drug Administration. (2022). Drug approvals and patent listings.
- GSK. (2022). Nucala prescribing information.
- Avalere. (2022). Biosimilar market entry projections.
