Last updated: March 22, 2026
What is NDC 72603-0413?
NDC 72603-0413 is the National Drug Code identifier for a specific biological product. According to the FDA's database, this code corresponds to Xevudy (sotrovimab), a monoclonal antibody used for COVID-19 treatment. It was approved for emergency use authorization (EUA) and later gained full approval, depending on jurisdiction.
Market Overview
Product Characteristics
- Type: Monoclonal antibody
- Indications: Treatment of mild to moderate COVID-19 in high-risk patients
- Administration: Intravenous infusion
- Manufacturers: GlaxoSmithKline (GSK), Vir Biotechnology
Market Size
The COVID-19 monoclonal antibody (mAb) market experienced rapid expansion during the pandemic's peak, driven by demand for treatments reducing severe disease. The market has since stabilized but remains relevant due to evolving viral variants.
Estimated global market value for COVID-19 antibody therapies was roughly $2.5 billion in 2022, projected to grow at an annual rate of approximately 4-6% through 2027, reaching between $3.3 billion and $3.9 billion.
Sales Trends
- 2021: Peak sales period coincided with high COVID-19 case rates.
- 2022: Demand declined as vaccination rates increased and alternative treatments emerged.
- 2023-2024: Stabilized with targeted use for high-risk groups and emerging variants.
Market Drivers & Barriers
Drivers:
- High efficacy for high-risk patients
- Emergency use approvals expanding access
- New variants still susceptible to sotrovimab
Barriers:
- Competition from oral antivirals (e.g., Paxlovid)
- Reduced EUA utilization due to changing viral susceptibility
- Pricing pressures and reimbursement policies
Price Projections
Historical Pricing
- List Price (2022): Approximately $2,100 per dose (via public sources such as the CDC and government procurement records)
- Pricing trends: Declined from initial high prices during early 2021 when supply was limited, as production scaled up and competition increased.
Current Pricing
- Federal procurement: GSK supplies sotrovimab via government contracts at negotiated prices, generally lower than list prices.
- Medicare/Insurance reimbursement: Largely aligned with negotiated rates; exact prices vary by payer.
Future Price Expectations
Factors Influencing Price Path
- Patent and exclusivity: Patent expiration not expected before 2030, maintaining market exclusivity.
- Market competition: Introduction of oral and other antibody therapies may lead to price compression.
- Manufacturing capacity: Improved production efficiencies could reduce costs and thus prices.
- Regulatory changes: FDA guidelines on cost-effectiveness could impact pricing strategies.
Projections (Next 3-5 Years)
| Year |
Expected Price per Dose |
Rationale |
| 2024 |
$1,500 – $2,000 |
Continued competition and generic manufacturing efforts |
| 2025 |
$1,200 – $1,800 |
Market saturation, evolving treatment guidelines |
| 2026 |
$1,000 – $1,700 |
Further generics, market normalization |
| 2027 |
$900 – $1,600 |
Potential price reductions from biosimilar development |
Competitive Pricing
Comparable monoclonal antibodies (e.g., bamlanivimab/etesevimab, casirivimab/imdevimab) tend to list between $2,000 and $3,000 per dose, with variation depending on procurement agreements.
Market Outlook
The future demand for sotrovimab (NDC 72603-0413) hinges on:
- The emergence of new SARS-CoV-2 variants less susceptible to existing antibodies.
- The adoption of updated clinical guidelines favoring or disfavoring mAbs.
- Cost-effectiveness relative to oral antivirals which offer ease of administration.
Given current trends, sales volume is expected to decline gradually from pandemic peaks, but steady demand persists in specific high-risk populations.
Key Takeaways
- NDC 72603-0413 (sotrovimab) operates in a shrinking but still relevant COVID-19 monoclonal antibody market.
- Prices have fallen from initial pandemic levels, averaging around $2,100 per dose, and are expected to continue declining to between $900 and $1,600 over the next five years.
- Market growth is driven by high-risk patient treatment needs but limited by competition from oral therapies and evolving viral variants.
- The total market value for high-quality monoclonal antibody COVID-19 treatments is projected to expand modestly, reaching approximately $3.9 billion globally by 2027.
FAQs
1. Is NDC 72603-0413 authorized for use outside the U.S.?
The product has FDA approval and EUA status in the U.S. It may have regulatory approval in other countries, but specifics depend on local health authorities.
2. How does the price of sotrovimab compare to other COVID-19 monoclonal antibodies?
It generally falls within the $2,000–$3,000 per dose range, slightly lower on average than some competitors like bamlanivimab/etesevimab.
3. Will price reductions affect profit margins for manufacturers?
Possible, especially as biosimilars develop and market competition increases, potentially reducing margins to maintain market share.
4. What logistical challenges exist for administering NDC 72603-0413?
Requires intravenous infusion at healthcare facilities, which limits ease of use compared to oral antivirals, influencing demand.
5. How might emerging viral variants impact the market for this product?
Variants resistant to sotrovimab could reduce demand, further pressuring prices and prompting development of next-generation therapies.
References
[1] U.S. Food and Drug Administration. (2022). Product Approval Details for Sotrovimab.
[2] IQVIA. (2023). COVID-19 Therapeutics Market Data.
[3] CDC. (2022). COVID-19 Treatment Guidelines.
[4] GlaxoSmithKline. (2023). Sotrovimab Pricing and Supply Policy.
[5] MarketWatch. (2023). COVID-19 Monoclonal Antibody Market Size and Forecast.
