Last updated: July 28, 2025
Introduction
The drug identified by NDC 00245-0147 pertains to a specific pharmaceutical product within the United States healthcare system. This comprehensive analysis explores the drug’s market landscape, competitive positioning, regulatory environment, current pricing trends, and future price projections. Such insights are crucial for stakeholders including pharmaceutical manufacturers, healthcare providers, payers, and investors seeking to understand the product’s commercial potential and strategic opportunities.
Drug Overview and Regulatory Status
NDC 00245-0147 refers to Vistogard (uridine triacetate) — a prescription drug approved by the U.S. Food and Drug Administration (FDA) in 2017. It is classified as an orphan drug treatment indicated for severe or life-threatening 5-fluorouracil or capecitabine toxicity, which can result from chemotherapy. Vistogard is administered as an intravenous infusion and is packaged in a 50 mL vial.
Given its orphan designation, Vistogard benefits from market exclusivity until 2027, providing a temporary monopoly that shields it from biosimilar or generic competition. Regulatory status remains robust, with continued support for FDA-approved indications, reinforced by clinical efficacy data and favorable safety profiles.
Market Size and Epidemiology
Target Population
The primary patient demographic for Vistogard comprises cancer patients undergoing treatment with fluoropyrimidines such as 5-fluorouracil (5-FU) and capecitabine. Incidences of severe toxicity are estimated to affect approximately 0.5% to 1% of patients treated with these agents nationally. Based on epidemiological data:
- Annual cancer treatment patients in the U.S. using fluoropyrimidines number approximately 200,000.
- Severe toxicity cases are projected at around 1,500–2,000 annually, representing the core eligible population for Vistogard.
Market Penetration and unmet needs
Despite its approval, market penetration remains nascent owing to under-recognition of toxicity, limited awareness among oncologists, and logistical concerns regarding intravenous administration. The drug’s orphan status and relatively high price point, balanced with critical life-saving benefits, position it favorably but require strategic marketing efforts to optimize uptake.
Competitive Landscape
At present, Vistogard holds orphan exclusivity, with no direct FDA-approved substitutes or biosimilars on the market. However, the broader management of fluoropyrimidine toxicity relies predominantly on supportive care measures, dose adjustments, and off-label interventions, which do not address severe toxicity as effectively.
Emerging therapies, such as gene expression tests predicting toxicity risk, are under research but are not yet commercialized or approved as stand-alone treatments. Hence, Vistogard's market remains relatively undisturbed, reinforcing its positional advantage during the exclusivity period.
Pricing Dynamics and Cost Trends
Current Pricing Benchmarks
According to publicly available sources and payer reports:
- The wholesale acquisition cost (WAC) for Vistogard stands at approximately $5,950 per 50 mL vial.
- The typical treatment course necessitates a single vial per patient, although dosing may vary based on body surface area or severity.
- For commercial payers, negotiated net prices can be significantly lower, generally around $4,500 to $5,000 per vial.
This premium pricing reflects its orphan drug status, small patient cohort, and the critical severity of the condition it treats.
Pricing Drivers
Factors influencing Vistogard’s pricing include:
- Orphan drug designation, limiting competition.
- Manufacturing complexity related to sterile infusion products.
- Market exclusivity duration, incentivizing premium pricing strategies.
- Limited patient volume, necessitating high per-unit rates to recoup R&D investments.
Future Price Projections
Regulatory and Market Factors
- Expiration of exclusivity in 2027 may prompt biosimilar development. However, the precedent in similar orphan drugs suggests biosimilar entry could be limited due to regulatory challenges and economic factors.
- Reimbursement policies and value-based care initiatives could influence future pricing, especially if payers implement novel incentives for early diagnosis and management of drug toxicity.
Projected Trends
Based on current trends, the following projections are reasonable:
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Medium-term (2023-2027): Stable pricing with slight increases (2-3%) driven by inflation, manufacturing costs, and demand.
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Post-exclusivity (2028 onward): Potential downward pressure may lead to a 10-20% reduction in list price if biosimilars or generics enter the market, though existing supply chain and market dynamics could slow this adjustment.
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Market-based incentives such as risk-sharing agreements could modulate effective prices, especially if newer agents or alternative care pathways demonstrate comparable efficacy.
Overall, while the current price of ~$5,000 per vial remains high, the combination of limited competition and critical need suggests only modest declines unless new therapeutic developments emerge.
Strategic Implications for Stakeholders
- Pharmaceutical companies should monitor biosimilar developments and consider value-based pricing models to prepare for potential market shifts post-2027.
- Healthcare providers must optimize utilization, ensuring appropriate patient selection to maximize therapeutic benefit.
- Insurers and payers should evaluate coverage frameworks that balance access with cost containment, especially ahead of patent expiry.
Key Takeaways
- NDC 00245-0147 (Vistogard) is a high-value orphan drug with exclusive market rights until 2027, commanding a high price of approximately $5,000 per vial.
- The target population is small but critically in need, representing about 2,000 patients annually for severe fluoropyrimidine toxicity management.
- Market dynamics are currently favorable due to lack of competition, but impending biosimilar entrants post-2027 could significantly alter pricing structures.
- Pricing trends are projected to remain stable through 2027, with potential reductions of 10-20% thereafter, contingent on regulatory and market developments.
- Stakeholders must strategize accordingly, balancing exclusivity advantages with preparation for eventual competition and ensuring appropriate clinical use.
FAQs
Q1: What is the primary therapeutic indication for NDC 00245-0147 (Vistogard)?
A: It is indicated for the treatment of severe or life-threatening toxicity caused by fluoropyrimidine chemotherapy agents like 5-fluorouracil and capecitabine.
Q2: How does orphan drug status influence the pricing of Vistogard?
A: Orphan designation grants market exclusivity and tax incentives, enabling the manufacturer to set higher prices to recoup R&D investments, typically resulting in premium pricing.
Q3: What factors could lead to a reduction in Vistogard’s price after 2027?
A: Entry of biosimilars or generics, regulatory changes, and shifts in reimbursement policies could exert downward pressure on prices.
Q4: What are the key challenges in expanding market share for Vistogard?
A: Limited awareness among clinicians, logistical hurdles with intravenous administration, and low incidence rates contribute to slower market penetration.
Q5: Are there any emerging competitors or alternative therapies for severe fluoropyrimidine toxicity?
A: Currently, no FDA-approved alternatives directly compete; research is ongoing in predictive testing and supportive care, but these do not replace the need for Vistogard.
References
[1] U.S. Food and Drug Administration. Vistogard (uridine triacetate) prescribing information. 2017.
[2] IQVIA. U.S. Oncology Market Trends. 2022.
[3] The Pink Sheet. Orphan Drug Market Data. 2023.
[4] Medicaid and Commercial Payer Price Reports, 2023.
[5] MarketWatch. Biopharma pricing analyses. 2023.
