Last updated: March 13, 2026
What is the Drug Associated with NDC 53746-0711?
NDC 53746-0711 corresponds to Siltuximab (Sylvant). It is a monoclonal antibody developed by Janssen Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2014, it treats multicentric Castleman’s disease (MCD) in patients who are HIV-negative or HHV-8-negative.
Current Market Landscape
Approved Indications and Usage
- Indication: Treatment of idiopathic multicentric Castleman’s disease
- Approval date: June 2014
- Administration: Intravenous infusion, typically 11 mg/kg every three weeks
- Patient population: Rare disease, estimated to affect fewer than 2,200 patients in the U.S. annually
Market Size Estimation
- Primary market: Patients with idiopathic multicentric Castleman’s disease
- Estimated prevalence: 1 to 2 cases per million people (globally)
- U.S. prevalence: Approximately 600 to 1,200 patients annually
Competitors
- No direct FDA-approved alternatives
- Off-label treatments: Chemotherapy agents, corticosteroids
- Clinical trials ongoing: Several investigational agents targeting IL-6 pathways
Market Trends
- Growing awareness of cytokine-targeted therapies
- Potential expansion into other IL-6-related diseases such as systemic juvenile idiopathic arthritis
- Limited alternative therapies restrict market competitors
Pricing Dynamics
Current List Price
- Wholesale Acquisition Cost (WAC): Approximately $4,015 per 50 mg vial (as of 2023)
- Typical dose: 11 mg/kg (average 80 kg patient = ~880 mg per dose)
- Per treatment cycle estimate: $70,500 (based on 880 mg at ~$4,015 per 50 mg)
Reimbursement and Payment Considerations
- Insurance coverage varies; drug covered under specialty pharmacy programs
- Out-of-pocket cost: Patient expenses depend on insurance copays, generally high for rare disease treatments
- Medicaid and Medicare reimbursements: Usually aligned with CMS fee schedules
Price Trends and Outlook
- List price has remained stable since approval
- No significant discounts or biosimilar options exist
- Reimbursement trends favor high-cost specialty drugs
Price Projections
| Year |
Estimated Average Price (per dose) |
Commentary |
| 2023 |
$4,015 |
Current WAC per 50 mg vial |
| 2024 |
$4,015 |
Stable, no biosimilars on market |
| 2025 |
$4,015 |
Expected to remain stable unless market shifts |
Anticipated factors influencing future prices include regulatory changes, competitive biosimilar entries (limited for monocl. antibodies in this niche), and reimbursement policy updates. Given the rarity of the disease, price reductions are unlikely unless a biosimilar enters the market.
Future Market Expansion and Pricing
- Indication expansion to other IL-6 related conditions could drive demand
- Larger patient populations may justify higher total sales volume
- Potential for pricing adjustments if biosimilars enter the market, though none are imminent
Revenue Opportunity Assessment
- Estimated annual U.S. sales: $60 million to $100 million (based on patient prevalence and pricing)
- Growth potential limited due to the rare disease status
- International markets: Regulatory approval varies; some regions may mirror U.S. price points
Regulatory and Policy Factors
- Patent protection extends until at least 2027
- No current biosimilars approved in the U.S. for Siltuximab
- The rarity of the disease limits the scope for widespread price erosion
Key Takeaways
- NDC 53746-0711 corresponds to Siltuximab, approved for multicentric Castleman’s disease.
- The current drug price per treatment cycle remains around $70,000, with stability likely in the near term.
- Market size remains small due to disease rarity but offers steady revenue with limited competition.
- Pricing could be impacted by biosimilar development, but none are imminent.
- Expanded indications may provide growth opportunities but will not significantly alter the Chinese market landscape soon.
FAQs
1. What are the main drivers of Siltuximab's market value?
The rarity of multicentric Castleman’s disease limits volume, but high drug price and no direct competitors sustain its value.
2. Are biosimilars expected to enter the Siltuximab market?
Currently, no biosimilars have received FDA approval, and patent protection until 2027 restricts biosimilar development.
3. How does Siltuximab compare to related IL-6 inhibitors?
It is approved specifically for multicentric Castleman’s disease without direct competition. Other IL-6 inhibitors target different conditions.
4. What factors could influence future price adjustments?
Introduction of biosimilars, regulatory changes, expanded indications, or reimbursement policy reforms.
5. Is the treatment cost likely to decrease over time?
Unlikely in the near term due to the absence of biosimilars and the market exclusivity of Siltuximab.
References
[1] U.S. Food and Drug Administration. (2014). FDA approves Sylvant for multicentric Castleman’s disease. Retrieved from https://www.fda.gov
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] Drugs.com. (2023). Siltuximab pricing and reimbursement overview.
[4] AdisInsight. (2023). Siltuximab development and pipeline status.
