Last updated: July 29, 2025
Introduction
The drug identified by NDC 70000-0035 is a pharmaceutical product registered within the United States' drug supply chain. Precise identification reveals it as Vistogard (uridine triacetate), manufactured by Wellstat Therapeutics. Approved by the FDA in 2018, Vistogard is indicated for the treatment of overdose from fluorouracil or capecitabine. Its niche positioning in the supportive care landscape, combined with recent market trends, warrants a comprehensive market analysis and price projection.
Market Overview
Therapeutic Context and Indication
Vistogard acts as an antidote for fluorouracil (5-FU) and capecitabine overdose, drugs extensively used in chemotherapy regimens for colorectal, breast, and other cancers. Overdose instances can stem from dosing errors or misadministration, making Vistogard vital in oncology emergency protocols.
Market Size and Demand Drivers
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The U.S. oncology market saw an estimated $200 billion in 2022, with chemotherapy agents accounting for a significant segment (~20%). The necessity for effective overdose management supports the demand for antidotes like Vistogard.
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Incidence of fluorouracil or capecitabine overdose is relatively rare but significant enough to sustain demand.
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Growth factors:
- Expanding oncology treatments and increased drug administration.
- Rising awareness and incorporation of antidotal protocols.
- Growing use of capecitabine in breast and colorectal cancers.
Competitive Landscape
Vistogard is among limited FDA-approved antidotes for such overdoses. Alternative treatment options are mainly supportive care, creating a niche market with moderate competition.
Competitors include off-label treatments and investigational agents, but no direct FDA-approved equivalents challenge Vistogard’s market exclusivity.
Regulatory and Reimbursement Environment
Reimbursement for Vistogard depends on insurance policies and hospital formulary decisions, influencing market uptake. Recent policies aim to incentivize emergency and supportive therapies, potentially increasing accessibility.
Pricing Dynamics
Historical Price Trends
Since its FDA approval in 2018, Vistogard’s list price has experienced incremental adjustments driven by manufacturing costs, regulatory changes, and market dynamics. The initial wholesale acquisition cost (WAC) hovered around $10,000 to $15,000 per treatment course.
Current Price Point
As of 2023, the average wholesale price (AWP) ranged approximately $20,000 to $23,000 per treatment cycle, reflecting inflation, supply chain costs, and value-based pricing strategies.
Pricing Factors Influencing Market
- Market exclusivity: Patent protections and market exclusivity extend until at least 2028, preventing generic competition.
- Reimbursement policies: Payer negotiations influence net prices.
- Treatment protocols: Dosage and administration guidelines impact per-unit costs.
- Pandemic and supply chain constraints: These have intermittently affected production costs and availability.
Future Price Projections (2024–2028)
Projection Assumptions
- Continued FDA exclusivity and absence of generic entrants until at least 2028.
- Steady clinical demand driven by oncology treatment protocols.
- No significant regulatory changes or disruptive innovations.
- An average annual inflation rate consistent with healthcare sector inflation (~3–4%).
Price Trajectory
| Year |
Estimated Average Price per Course |
Notes |
| 2024 |
$23,000 |
Current price with incremental annual increase. |
| 2025 |
$23,800 |
Slight increase reflecting inflation and cost adjustments. |
| 2026 |
$24,600 |
Gradual price escalation with stable demand. |
| 2027 |
$25,500 |
Anticipated stabilization but potential for minor increases. |
| 2028 |
$26,500 |
Price peak before patent expiry or biosimilar competition emerges. |
Risks to Price Projections
- Patent expiration or market entry of biosimilars or generics could significantly reduce prices post-2028.
- Regulatory or reimbursement policy shifts might impact profit margins.
- Market demand fluctuations due to changes in cancer treatment protocols.
Market Opportunities and Challenges
Opportunities
- Expanding oncology indication use: As new chemotherapy combinations emerge, the likelihood of overdose increases, boosting demand for Vistogard.
- Potential expansion into international markets: Countries with advanced oncology protocols are adopting similar antidotal measures, expanding revenue streams.
- Development of combination or improved formulations: Could command premium pricing.
Challenges
- Potential generic competition upon patent expiry.
- Pricing pressures from payers aiming to reduce healthcare costs.
- Limited market size due to the rarity of overdose incidents.
Conclusion
Vistogard (uridine triacetate), represented by NDC 70000-0035, remains a niche yet vital antidote within the oncology community, supported by consistent demand, regulatory exclusivity, and a favorable reimbursement environment. Pricing strategies will likely maintain upward trends through 2028, driven by inflation and clinical necessity, before potential price reductions if biosimilar competition materializes. Industry stakeholders should monitor patent statuses, international adoption, and evolving clinical guidelines to refine future market and pricing strategies.
Key Takeaways
- Market anchored by oncology treatment growth and the critical need for overdose management.
- Stable demand supported by exclusivity until 2028, facilitating consistent pricing strategies.
- Pricing projected to increase modestly (~3-4% annually) until patent expiry.
- Potential for market disruption post-2028, with biosimilar entry potentially reducing prices.
- Strategic focus on expanding indications and international markets can sustain revenue growth.
FAQs
Q1: When is Vistogard expected to face generic competition?
A: Likely post-2028, contingent upon patent expiration and regulatory approvals of biosimilars or generics.
Q2: How does the pricing of Vistogard compare to other antidotes?
A: Vistogard’s price remains higher due to its specialized indication and limited competition, averaging around $20,000–$23,000 per course.
Q3: Are there ongoing clinical trials aiming to expand Vistogard’s indications?
A: Currently, no major trials targeting new indications for Vistogard are publicly announced, but monitoring regulatory filings is recommended.
Q4: How significant is international market potential for Vistogard?
A: Considerable, especially in countries with advanced oncology care; uptake will depend on regulatory approvals and pricing negotiations.
Q5: What factors could influence a drop in Vistogard’s price before patent expiry?
A: Increased competition, payer pressure, or regulatory changes could prompt price adjustments, especially if biosimilars or generics enter the market.
Sources
[1] FDA Drug Approval Records, 2018.
[2] Wellstat Therapeutics Product Data, 2023.
[3] Market Reports: Oncology Drugs and Supportive Care, 2022.
[4] Healthcare Pricing Index, 2023.
