Last updated: February 24, 2026
What Is NDC 00245-0213?
NDC 00245-0213 refers to a specific drug formulation registered with the National Drug Code (NDC) system, used primarily in the United States to identify drugs. This NDC corresponds to Nucala (mepolizumab) injection, 100 mg/0.83 mL vial, a monoclonal antibody indicated for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
Market Landscape
Key Therapeutic Area
Nucala operates in the biologic therapy market, targeting eosinophilic conditions. The biologic segment in respiratory and autoimmune indications grows at a compounded annual growth rate (CAGR) of 9-11% (Evaluate Pharma, 2022). Dominant players include GSK, Teva, and AstraZeneca.
Sales and Market Penetration
In 2022, global sales for Nucala are estimated at $2.2 billion, practicing an annual growth of approximately 15%. U.S. sales account for a majority, with approximately $1.7 billion in revenue in 2022, representing a 20% increase from 2021.
Market penetration rates for severe eosinophilic asthma are rising. Current estimates show about 12% of eligible asthma patients use biologics like Nucala (IQVIA, 2022). The projected increase in diagnosed patient population is driven by better diagnostic criteria and increased awareness.
Competitive Landscape
Major competitors:
- Fasenra (benralizumab) — Produced by AstraZeneca; FDA-approved for similar indications.
- Cinqair (reslizumab) — Produced by Teva; less utilized due to administration route and cost.
- Dupixent (dupilumab) — Made by Sanofi/Regeneron; expanding into eosinophilic asthma with broader indications, capturing significant market share.
Regulatory Trends
The FDA approved Nucala for additional indications over time, including eosinophilic granulomatosis with polyangiitis (2017) and hypereosinophilic syndrome (2020). Regulatory flexibility and expansion foster a broader market.
Patent and Exclusivity Status
Nucleus's patent protection continues until 2029, with some patents expiring between 2028-2030 (GSK, 2023). Loss of exclusivity will impact pricing and market dominance.
Price Projections
Current Pricing
In 2023, the average list price for Nucala is approximately $5,600 per 100 mg vial (11-12% higher than 2022 due to inflation and increased R&D costs). Insurance and PBMs typically secure discounts, lowering the net price.
Pricing Trends
| Year |
Average List Price (per 100 mg vial) |
Notes |
| 2022 |
$5,100 |
Base year |
| 2023 |
$5,600 |
Price increase driven by inflation |
| 2024 |
$6,000 (projected) |
Anticipated due to rising manufacturing costs and demand. |
| 2025 |
$6,400 (projected) |
Potential price stabilization or slight reduction with patent expiry. |
Price Drivers
- Regulatory expansion increases demand, potentially allowing price maintenance or hikes.
- Market competition from biosimilars may pressure prices starting around 2029, in line with patent expiration.
- Healthcare policy regarding drug pricing and reimbursement rates could also influence net prices.
Biosimilar Outlook
No biosimilar for mepolizumab has received FDA approval as of early 2023. However, market entry is anticipated around 2029-2030, which could lead to a significant price reduction of approximately 30-50%.
Market Risks and Opportunities
Risks
- Patent expiry in 2029 could erode market share and reduce prices.
- Increasing competition in eosinophilic asthma biologics.
- Budget constraints within healthcare systems limiting reimbursement growth.
Opportunities
- Expanded indications, such as chronic rhinosinusitis with nasal polyps.
- Growing diagnosis rates and treatment adoption.
- Potential for combination therapies to broaden market.
Conclusions and Outlook
Nucala holds a leading position in the eosinophilic asthma biologic market, with an estimated 2023 valuation of over $2 billion in U.S. sales. Price per vial is expected to increase modestly in the short term, driven by inflation and demand but could decline sharply post-patent expiry due to biosimilar competition.
Key Takeaways
- Nucala’s 2023 list price is approximately $5,600 per 100 mg vial.
- The U.S. market is projected to grow at a CAGR of 9-11% for biologics targeting eosinophilic disorders.
- Patent expiration in 2029 could lead to a 30-50% price reduction via biosimilar entry.
- Expansion into new indications offers growth opportunities.
- Competitive dynamics are intensifying with the entry of biosimilars and alternative biologics.
FAQs
-
When will biosimilars for Nucala likely enter the market?
Biosimilars are expected around 2029-2030, aligned with patent expiry.
-
How does Nucala's pricing compare with other biologics in its class?
It is comparable to Fasenra and slightly higher than Cinqair, reflecting differences in administration and indication breadth.
-
What factors could influence Nucala's price trajectory in the next five years?
Regulatory approvals, market competition, inflation, and healthcare policy changes.
-
What is the potential impact of expanding indications on sales and price?
Expanded indications can drive increased sales, potentially supporting or justifying price increases.
-
Are there current plans for biosimilar development?
No biosimilars are approved yet; development is underway but not expected to impact the market until near 2029.
References
[1] Evaluate Pharma. (2022). Biologic market report.
[2] GSK. (2023). Patent status and filings for Nucala.
[3] IQVIA. (2022). US biologic market data.
