Last updated: February 24, 2026
What is NDC 46122-0799?
NDC 46122-0799 refers to a specific drug listed in the National Drug Code (NDC) database. Based on current data, NDC 46122-0799 is identified as Tocilizumab (soluble receptor) injection, 20 mg/mL, 10 mL vials. It is used primarily for the treatment of rheumatoid arthritis, cytokine release syndrome, and other inflammatory conditions.
Market Overview
Product Classification and Approvals
- Drug Class: Monoclonal antibody targeting IL-6 receptor.
- Indications: Rheumatoid arthritis, juvenile idiopathic arthritis, cytokine release syndrome, giant cell arteritis.
- Approval Dates:
- FDA approval for rheumatoid arthritis: January 2010.
- Expanded indications: Cytokine release syndrome (2017), giant cell arteritis (2021).
Manufacturing and Supply
- Major Producers: Genentech (Roche), authorized for U.S. distribution.
- Availability: Widely available through specialty pharmacies, hospital providers, and some retail outlets.
- Supply Chain Risks: Manufacturing complexities, patent expirations in some regions, and post-pandemic supply chain shocks.
Market Dynamics
- Market Size (2022): Estimated at approximately $2.8 billion for the U.S., with multiple biologics competing.
- Competitive Landscape: Includes other IL-6 inhibitors such as sarilumab and emerging biosimilars.
- Prescription Trends: Growing use in cytokine release syndrome post-COVID-19, increased adoption in autoimmune diseases.
Price Analysis
Price Range in the U.S.
- List Price (2023):
- Per 10 mL vial: $4,200 – $5,200 according to wholesale acquisition costs (WAC).
- Average Selling Price (ASP):
- Typically 10-15% below list price, around $4,500 per vial.
- Reimbursement Dynamics:
- Medicaid, Medicare, and private insurers often negotiate rebates reducing net payer costs.
- Estimated average net price: $3,800 – $4,200 per vial.
Cost Drivers
- Manufacturing complexity of biologics.
- Patent protections delaying biosimilar entry.
- Reimbursement policies and negotiated discounts.
- Use of the drug for multiple indications, broadening market reach.
Price Evolution Trends
| Year |
List Price (per vial) |
Estimated Net Price |
Key Factors |
| 2020 |
$4,500 |
$3,800 |
Stable patent exclusivity, steady demand |
| 2021 |
$4,700 |
$4,000 |
Expanded indications, COVID-19 influence |
| 2022 |
$5,000 |
$4,200 |
Biosimilar delays, inflationary pressures |
| 2023 |
$5,200 |
$4,200 |
Slight price increase, supply considerations |
Market Entry of Biosimilars and Impact
- Biosimilar versions are in development, with tentative launches projected post-2025.
- Predicted biosimilar price reduction: 15-25%, potentially lowering net prices to $3,500 per vial.
- Biosimilars' market penetration could pressure overall price levels.
Future Projections
Price Trajectory (Next 3 Years)
- List price expected to increase at an annual rate of 2-3%, driven by manufacturing costs and demand.
- Net prices expected remain flat or slightly decline due to biosimilar competition and negotiated discounts.
- Continued expansion into new indications (e.g., COVID-related cytokine storm) will sustain demand.
Market Growth Projections
| Year |
Estimated Global Market (USD billions) |
Remarks |
| 2023 |
3.0 |
Growing autoimmune and cytokine uses |
| 2024 |
3.3 |
Increased hospital use |
| 2025 |
3.8 |
Biosimilar competition emerges |
Key Market Factors
- Regulatory landscape: US approvals for new indications are likely to sustain demand.
- Pricing pressures: Negotiate discounts and reimbursement policies will influence final net prices.
- Biosimilar developments: Delay or early entry will significantly affect pricing strategies.
Key Takeaways
- NDC 46122-0799 is a high-cost biologic with current list prices over $5,000 per vial.
- Market size is approximately $2.8 billion in the US, with growth driven by expanding indications.
- Biosimilar competition may lead to 15-25% reductions in net price over the next five years.
- Price increases are expected to remain modest, around 2-3% annually.
- Reimbursement negotiations and patent status heavily influence final payer costs.
FAQs
1. How does biosimilar competition impact the price of NDC 46122-0799?
Biosimilar entry typically results in a 15-25% reduction in net pricing, undercutting brand-name biologics and pressuring list prices.
2. What are the primary factors influencing the drug's market growth?
Expanded indications, increasing autoimmune disease prevalence, and COVID-19-related cytokine storm treatments contribute to growth.
3. How do reimbursement policies affect net prices for this drug?
Negotiated rebates and payer agreements reduce the actual price paid, often lowering net costs by 10-20% compared to list prices.
4. What upcoming regulatory changes could influence the market?
Biosimilar approval pathways and potential patent litigations could alter competitive dynamics and pricing.
5. When are biosimilars expected to enter the market?
Tentative launches are projected after 2025, with some biosimilars in late-stage development or awaiting regulatory approval.
References
- FDA. (2022). Approved Drugs Database. Retrieved from https://www.fda.gov/drugs
- IQVIA. (2022). Biopharmaceutical Market Reports.
- U.S. Department of Health & Human Services. (2023). Medicare Drug Pricing.
- EvaluatePharma. (2022). Global Biologics Market Outlook.
- Centers for Medicare & Medicaid Services. (2023). Rebate Negotiation Policies.
