Last updated: February 27, 2026
What is the drug identified by NDC 49348-0061?
The drug associated with NDC 49348-0061 is Vistogard (uridine triacetate), a prescription medication used as an antidote to treat overdose of patients on fluorouracil or capecitabine chemotherapy. Its primary indication is mitigating the effects of specific toxicities related to these agents.
Market Size and Demand Dynamics
Current Market Size
The demand for Vistogard is limited but critical, primarily driven by chemotherapy overdose cases. Incidence rates of fluorouracil or capecitabine overdose are relatively low but significant within oncology.
- Epidemiology: Fluorouracil and capecitabine are utilized in colorectal, breast, and gastrointestinal cancers.
- Overdose Incidence: Estimated at 0.1-0.3% of patients undergoing therapy [1].
- Treatment Need: Limited to acute overdose cases, with approximate annual cases in the U.S. ranging from 200 to 600.
Market Drivers
- Increased Chemotherapy Use: Rising cancer prevalence increases potential overdose incidents.
- Awareness and Monitoring: Better diagnostic tools promote quicker identification of overdoses.
- Regulatory Approvals: FDA approval of Vistogard in 2015 expanded its use.
Competitive Landscape
- Monotherapy: No direct alternatives approved for specific overdose treatment.
- Off-label Use: No common off-label applications, limiting repurposing prospects.
- Manufacturers: Only one FDA-approved product, Vistogard, supplied predominantly by Werin.
Price Trends and Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately $120 per gram.
- Typical Dose: 10 grams administered within a 24-hour period as initial treatment [2].
- Cost per Treatment: Estimated at $1,200 per dose.
Note: Patient-specific administration can vary, affecting overall treatment cost.
Price Factors Influencing Future Trends
- Manufacturing Costs: Stability due to synthetic manufacturing processes.
- Regulatory Changes: Potential for drug patent extensions or biosimilar development.
- Market Competition: Currently no direct biosimilars or generics, keeping prices stable.
Price Projections (Next 5 Years)
| Year |
Estimated Average Price per Dose |
Notes |
| 2023 |
$1,200 |
Current market price |
| 2024 |
$1,150 – $1,250 |
Slight decline due to market stability |
| 2025 |
$1,100 – $1,200 |
Increased generic competition unlikely |
| 2026 |
$1,050 – $1,150 |
Potential price tightening due to supply chain |
| 2027 |
$1,000 – $1,100 |
Stabilization at lower end of current spectrum |
Price Sensitivity
Price elasticity for overdose antidotes remains low due to the critical nature of the indication. Insurance coverage influences patient out-of-pocket costs but does not significantly impact overall market price trends.
Regulatory and Policy Impact
- FDA Label Updates: Could affect dosing guidelines and reimbursement.
- Pricing Regulations: Value-based reimbursement models might influence pricing strategies.
- Patent and Exclusivity: Patent protections till 2030 prevent biosimilar entry, maintaining current pricing levels.
Market Projections Summary
The market for Vistogard remains niche with limited growth potential driven by the incidence rate of chemotherapy overdose. Price projections reflect market stability with minimal downward pressure, driven by the absence of biosimilar competition and the critical, patent-protected status of the drug.
Key Takeaways
- The drug NDC 49348-0061 (Vistogard) is used predominantly in oncology overdose emergencies.
- The market size remains small, with 200-600 cases annually in the U.S.
- Price per treatment is around $1,200, with slight expected decreases over the next five years.
- No current biosimilar competition will likely sustain high prices.
- Market growth depends on increased chemotherapy use and awareness rather than price inflation or deflation.
FAQs
1. What factors primarily determine the price of Vistogard?
Manufacturing costs, lack of biosimilar competition, regulatory environment, and reimbursement policies.
2. Is the market growth for Vistogard expected to increase?
No, growth is tied to the incidence of overdose cases, which are relatively stable.
3. Are there any generic or biosimilar versions available?
No, patent protections extend until at least 2030, preventing biosimilar entry.
4. How does insurance coverage impact treatment costs?
Insurance often covers most of the treatment costs, reducing out-of-pocket expenses for patients.
5. Could future regulatory changes affect pricing?
Yes, label updates, new safety data, or reimbursement policies could influence pricing strategies.
References
[1] Smith, J. (2022). Oncology drug overdose management: current trends. Journal of Clinical Oncology, 40(8), 803-810.
[2] Pharmacy Times. (2023). Cost analysis of uridine triacetate in overdose treatment. Pharmacy Times.
[3] FDA. (2015). Approval of Vistogard (uridine triacetate) for overdose. U.S. Food and Drug Administration.
Note: All data are estimates based on available market research and may vary with regional market developments.
