Last updated: February 27, 2026
What is the drug associated with NDC 68599-4744?
NDC 68599-4744 corresponds to Mepolizumab injection (brand name Nucala). It is a monoclonal antibody designed to target interleukin-5 (IL-5), used for severe eosinophilic asthma and other eosinophil-driven conditions.
Market Overview
Indications and Market Penetration
- Approved by FDA in 2015 for severe eosinophilic asthma.
- Approved in multiple indications including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).
- Competitors include Reslizumab (Cinqair), benralizumab (Fasenra), and dupilumab (Dupixent).
Current Market Size
- The global asthma biologics market was valued at approximately USD 9.5 billion in 2021.
- Nucala’s U.S. market share in severe eosinophilic asthma was estimated at around 45% in 2022.
- Estimated U.S. sales in 2022: USD 2.3 billion, driven by increased diagnoses and treatment adoption.
Market Dynamics
- Growing prevalence of eosinophilic asthma drives demand.
- Increased diagnosis rates due to better biomarker testing.
- Expanded approved indications boost revenue potential.
- Patent exclusivity and biologic class dynamics impact pricing and market share.
Competitive Landscape
| Drug |
Year FDA approved |
Indications |
Annual sales (2022) |
Market share (2022) |
| Nucala (Mepolizumab) |
2015 |
Severe eosinophilic asthma, EGPA, HES |
USD 2.3B |
45% |
| Cinqair (Reslizumab) |
2016 |
Severe eosinophilic asthma |
USD 430M |
8% |
| Fasenra (Benralizumab) |
2017 |
Severe eosinophilic asthma |
USD 1.2B |
25% |
| Dupixent (Dupilumab) |
2017 |
Multiple indications including asthma |
USD 4.2B |
20% |
Price Projections
Current Pricing and Reimbursement
- Average wholesale price (AWP) per 100 mg vial: approximately USD 2,400.
- Typical patient regimen: 100 mg subcutaneously every 4 weeks.
- Annual drug cost per patient: USD 12,600 (assuming 13 doses/year).
Pricing Trends and Future Projections
- List prices are stable, but discounts and rebates impact net prices.
- Managed care negotiations and formulary placements drive patient access.
- Expected price stability over the next 3–5 years due to lack of biosimilar competition in the near-term.
Impact of Biosimilars and Competition
- Biologics are difficult to biosimilar due to complexity.
- No biosimilar approved for mepolizumab as of early 2023.
- Patent protections extend until 2030, with potential for patent challenges starting 2026.
Revenue and Market Share Projections (2023–2028)
| Year |
Estimated Global Sales |
U.S. Market Share |
Estimated U.S. Revenue |
Key Factors |
| 2023 |
USD 2.5B |
45% |
USD 1.125B |
Increased diagnosis, expanded indications, stable pricing |
| 2024 |
USD 2.75B |
45% |
USD 1.237B |
New treatment guidelines solidify biologic use |
| 2025 |
USD 3.0B |
45% |
USD 1.35B |
Patent protections remain, no biosimilar entry |
| 2026 |
USD 3.2B |
45% |
USD 1.44B |
Patent challenges, potential patent expiry discussions |
| 2027 |
USD 3.3B |
42% |
USD 1.386B |
Entry of biosimilar competitors possible, price competition increases |
Risks and Opportunities
Risks:
- Patent expiration risks influencing future pricing and market share.
- Increased competition from biosimilars and new therapies.
- Regulatory changes affecting pricing and reimbursement strategies.
Opportunities:
- Broadening of indications (e.g., nasal polyposis, chronic rhinosinusitis with nasal polyps).
- Development of subcutaneous formulations or extended dosing intervals.
- Potential for combination therapies.
Key Takeaways
- NDC 68599-4744 (mepolizumab) is a leading biologic in severe eosinophilic asthma, capturing significant market share since 2015.
- Current annual revenue in the U.S. exceeds USD 1.1 billion.
- Market growth is driven by increased diagnosis, expanded indications, and stable pricing.
- Patent protections are key to maintaining revenue; expiry expected around 2030.
- Biosimilar competition remains unlikely before 2026, supporting sustained high prices.
FAQs
1. Will the price of Nucala decrease after patent expiration?
Potentially. Patent expiry typically prompts biosimilar entry, which can lead to significant price reductions. However, biosimilars are complex and may face regulatory or market entry barriers.
2. Are there oral alternatives to mepolizumab?
Currently, no oral biologic alternatives exist. Small-molecule drugs are under investigation but are not yet available.
3. What is the expected impact of new indications?
Additional approvals, such as nasal polyposis, could expand the target patient population and increase revenue.
4. How do reimbursement policies affect pricing?
Rebate negotiations and formulary placements can significantly influence net prices, potentially lowering actual revenue per unit.
5. Are biosimilars likely to gain market share quickly after patent expiry?
Not immediately. Biologic biosimilar adoption depends on regulatory approval, physician acceptance, and payor preference, which can delay market penetration.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] EvaluatePharma. (2022). World Preview 2022.
[3] U.S. Food and Drug Administration (FDA). (2015). Nucala (mepolizumab) approval notice.
[4] MarketWatch. (2022). Biologics Market Size and Forecast.
[5] Research and Markets. (2022). Biologics and Biosimilar Market Analysis.
