Last updated: February 27, 2026
What is the Therapeutic Use of NDC 70000-0563?
NDC 70000-0563 is marketed as Zinplava (bezlotoxumab), a monoclonal antibody indicated for the prevention of Clostridioides difficile (C. difficile) recurrence in adult patients receiving antibacterial drug treatment for C. difficile infection (CDI).
Market Size and Epidemiology
- C. difficile infection incidence: Approximately 462,100 cases annually in the U.S. [1].
- Recurrence rate: ~20-30%, leading to an addressable market of roughly 92,420 to 138,630 patients yearly.
- Target patient population: Adults receiving antibiotics, with high-risk factors like immunosuppression, age over 65, history of CDI, or severe initial infection.
Competitive Landscape
- Existing options: Vancomycin, fidaxomicin, metronidazole.
- Prevention focus: Standard care emphasizes antibiotics, with no approved targeted monoclonal antibody therapies until Zinplava’s approval in 2016.
- Key competitors: No direct antibody competitors; the market is primarily driven by antibiotic prophylaxis and antibiotics with specific recurrence prevention strategies.
Pricing Overview
- Current Wholesale Acquisition Cost (WAC): Zinplava’s list price is approximately $3,300 per 100 mg vial [2].
- Typical dosing: 10 mg/kg administered as a single infusion; a 70 kg adult requires 700 mg, costing roughly $23,100 per dose.
- Reimbursed costs: Actual paid amounts vary; insurance coverage and discounts impact net price.
Market Dynamics and Trends
- Pricing pressure: Payers and healthcare systems push for value-based pricing with biosimilar development prospects.
- Adoption factors: Efficacy in high-risk populations drives utilization; hospital protocols influence prescribing.
- Regulatory environment: FDA approval supports market penetration; quality and manufacturing standards bolster confidence.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price per Dose |
Market Penetration |
Remarks |
| 2023 |
$23,100 |
50% of eligible patients |
Price remains stable amid payer negotiations. |
| 2024 |
$22,000 |
60% |
Slight price reductions with increased competition. |
| 2025 |
$21,000 |
70% |
Potential entry of biosimilars may push prices downward. |
| 2026 |
$20,000 |
80% |
Biosimilar presence intensifies price competition. |
| 2027 |
$18,000 |
90% |
Biosimilar market expansion; patent challenges decrease revenue. |
Risks and Opportunities
- Risks: Biosimilar entry, Medicaid rebate policies, changes in clinical guidelines.
- Opportunities: Expanded labels for other indications, combination therapies, increased clinician awareness.
Key Takeaways
- NDC 70000-0563 (Zinplava) has established a niche for recurrence prevention in CDI.
- The market size stays steady, with around 100,000 high-risk patients annually in the U.S.
- Price projections suggest gradual declines driven by biosimilar competition and payer pressure.
- Current therapy costs are high due to dosing requirements, but improved reimbursement dynamics could influence net pricing favorably.
- Market growth hinges on clinical adoption and regulatory flexibility.
FAQs
Q1: What is the primary indication for NDC 70000-0563?
It prevents recurrence of C. difficile infection in adult patients receiving antibiotics.
Q2: How does Zinplava compare price-wise to other CDI treatments?
Zinplava costs significantly more than traditional antibiotics; a single dose can reach over $23,000.
Q3: What are the main drivers of price reductions?
Introduction of biosimilars and increased market competition.
Q4: How many patients are eligible annually for Zinplava?
An estimated 100,000-150,000 U.S. adults with high risk of CDI recurrence.
Q5: What factors could influence future market growth?
Clinical guideline updates, expanding label indications, and healthcare payer policies.
References
- Lessa, F. C., et al. (2015). Burden of Clostridium difficile infection in the United States. New England Journal of Medicine, 372(9), 825–834.
- FDA. (2023). Zinplava (bezlotoxumab) prescribing information. Retrieved from https://www.accessdata.fda.gov
[Note: Data is based on the latest publicly available sources and market assumptions; actual market prices and dynamics may vary.]
