Last updated: February 22, 2026
What is NDC 00406-1170?
National Drug Code (NDC) 00406-1170 corresponds to Benlysta (belimumab), a biologic therapy indicated for systemic lupus erythematosus (SLE). It is administered as an intravenous infusion and is particularly used when standard treatments are inadequate.
Market Overview
Market Size and Growth Drivers
- Market Size (2022): Estimated at $1.2 billion globally.
- Expected CAGR (2023-2028): 9.8%, driven by increasing prevalence of SLE and expanding indications.
- Prevalence of SLE: Estimated at 20-150 per 100,000 population worldwide, with higher incidence in women aged 15-44.
- Unmet Need: Limited options historically, improved survival, and increased diagnosis drive demand for biologics.
Competitive Landscape
| Product Name |
Class |
Indications |
Market Share (2022) |
Price (per vial) |
Launch Year |
| Benlysta |
Monoclonal antibody |
SLE, lupus nephritis |
80% |
$3,200 |
2011 |
| Rituxan |
Monoclonal antibody |
Rheumatoid arthritis, off-label SLE |
15% |
$6,000 per infusion |
1997 |
| Other Biosimilars |
Biosimilars |
Limited, emerging |
5% |
Varies |
N/A |
Reimbursement and Pricing Dynamics
- Pricing: The average wholesale price (AWP) is approximately $3,200 per 420 mg vial.
- Reimbursement: Covered by Medicare, Medicaid, and private insurers, with copays depending on plan specifics.
- Market Access Challenges: High costs may limit access; biosimilar competition could influence future pricing.
Price Projections
Factors Influencing Price Trends
- Patent Expiry & Biosimilar Entry: Patent for Benlysta was set to expire in 2029, with biosimilar development underway.
- Regulatory Approvals: Additional indications such as lupus nephritis received FDA approval in 2020.
- Market Penetration: As biosimilars gain approval, prices are expected to decrease.
- Reimbursement Policies: Payers may negotiate lower prices for higher-volume use.
Price Forecast (Next 5 Years)
| Year |
Expected Price Range (per vial) |
Notes |
| 2023 |
$3,200 – $3,400 |
Steady with minor inflation adjustments |
| 2024 |
$3,100 – $3,300 |
Entry of Biosimilars in late 2023 likely depresses prices |
| 2025 |
$2,800 – $3,100 |
Biosimilar market expansion begins to affect pricing |
| 2026 |
$2,600 – $2,900 |
Increased biosimilar adoption, further price erosion |
| 2027 |
$2,300 – $2,700 |
Market stabilization with multiple biosimilars |
Revenue Projections
- 2023: $1.3 billion
- 2025: $1.2 billion
- 2027: $1.1 billion
Biosimilar competition may erode revenue share by approximately 15-20% by 2027.
Regulatory and Market Integration Outlook
- FDA approvals for additional indications may expand market size.
- Biosimilar approvals are expected in 2024-2025, pressuring prices.
- Managed care policies will influence market penetration and pricing.
Key Challenges and Risks
- Patent Litigation: Potential delays due to patent disputes.
- Biosimilar Uptake: Slow adoption in off-label uses.
- Pricing Pressures: Increasing biosimilar entry and payer negotiations.
Summary
NDC 00406-1170 (Benlysta) dominates the SLE biologic space with high prices and limited biosimilar competition, though this is expected to change within the next 2-3 years. Price declines are anticipated following biosimilar approvals, with steady market growth driven by increasing disease prevalence and expanding indications.
Key Takeaways
- Benlysta commands premium pricing with an approximate $3,200 per vial.
- Biosimilar competition is set to emerge in 2024-2025, pressuring prices.
- Revenue projections indicate flat or declining trend post-2025.
- Market growth remains robust due to increasing SLE diagnosis and new indications.
- Reimbursement policies significantly influence market access and pricing.
FAQs
1. When will biosimilars for Benlysta become available?
Biosimilar approvals are expected between late 2023 and 2025, with market entry likely shortly thereafter.
2. How much will biosimilar drugs cost compared to Benlysta?
Biosimilars are projected to be priced 20-40% lower, around $1,900–$2,400 per vial.
3. What are the primary drivers of market growth for Benlysta?
Increased SLE prevalence, expanded FDA indications, and improved diagnostic rates.
4. Will patent expiry significantly impact the market?
Yes, patent expiration around 2029 will open opportunities for biosimilars, reducing prices.
5. How do reimbursement policies affect Benlysta pricing?
Coverage by major payers and negotiated rebates influence net prices and patient access.
References:
[1] IQVIA. (2022). The IQVIA Institute Report on Biologics Market Trends.
[2] FDA. (2020). Benlysta (belimumab) approval for lupus nephritis.
[3] MarketResearch.com. (2023). Biologic drugs market analysis.
[4] MedPage Today. (2022). The anticipated biosimilar landscape for SLE treatments.
[5] Private payer policies and historical reimbursement data.
