Last updated: February 25, 2026
What Is NDC 68047-0713?
NDC 68047-0713 is identified as Vistogard (uridine triacetate). Vistogard is an FDA-approved antidote used for the treatment of overdose from fluorouracil or capecitabine, chemotherapeutic agents. It is also approved for preventing toxicity from these drugs in certain situations.
Market Overview
Therapeutic Area and Indications
Vistogard belongs to the class of agents known as antidotes for chemotherapy overdose. Its key indications include:
- Treatment of toxic overdose of fluoropyrimidines (fluorouracil and capecitabine)
- As an adjunct in cases of overdose or anticipated overdose
Market Drivers
- Increasing use of fluoropyrimidine-based chemotherapies in colorectal, breast, and gastric cancers
- Rising awareness of drug overdose management protocols
- FDA approval and expanded indications enhancing market access
- Adoption across oncology centers and hospitals
Market Size
The global oncology drug market was valued at approximately $150 billion in 2021. The specific segment for antidotes like Vistogard is smaller but growing.
Estimations for the Vistogard market:
- The U.S. accounts for most sales, given its advanced healthcare infrastructure and adherence to FDA guidelines
- The number of fluorouracil-related overdose cases has been steady, with approximately 200-300 cases annually in the U.S.
Competitive Landscape
Vistogard is currently the primary FDA-approved treatment for fluoropyrimidine overdose. Alternatives include:
- Supportive care measures
- Use of related compounds off-label in some situations
No significant generic or biosimilar competition exists as of the latest data.
Price Projections
Current Pricing
- The average wholesale price (AWP) for Vistogard is approximately $10,000 - $15,000 per treatment course.
- Treatment typically involves a 20-gram dose administered intravenously over 20 minutes, with costs factoring in hospital dispensing and administration fees.
Short-term Projection (Next 1-2 Years)
- Price stability expected due to lack of competition.
- Slight variations in pricing driven by hospital negotiations, insurance coverage, and procurement volume.
- No planned generic entrants; patent extensions or exclusivity are not publicly indicated.
Long-term Outlook (3-5 Years)
- Price could decline modestly if market penetration increases or if new formulations reduce treatment costs.
- Potential for price erosion if biosimilars or generics gain approval, though no biosmerit or patent challenge is currently reported.
- Market expansion driven by increased awareness and use might sustain high prices, but biosimilar introduction remains unlikely.
Policy Impact
- Insurance reimbursement policies influence market size and prices.
- Potential introduction of value-based pricing models could pressure prices downward.
Quantitative Price Projection Table
| Year |
Estimated Treatment Price |
Market Penetration |
Projected Revenue (U.S. Market) |
| 2023 |
$10,000 - $15,000 |
70% of overdose cases |
$20 million - $30 million |
| 2024 |
$10,000 - $15,000 |
80% of overdose cases |
$25 million - $35 million |
| 2025 |
$9,500 - $14,500 |
85% of overdose cases |
$27 million - $40 million |
| 2026 |
$9,000 - $14,000 |
90% of overdose cases |
$30 million - $45 million |
(Assumes steady increases in market uptake and stable pricing.)
Risks to Price Stability
- Emergence of biosimilars or alternative antidotes
- Changes in healthcare reimbursement policies
- Variability in overdose incidence rates
- Patent expiry or loss of exclusivity
Key Takeaways
- NDC 68047-0713 (Vistogard) has a niche market for fluoropyrimidine overdose antidote.
- Current prices range from approximately $10,000 to $15,000 per treatment.
- Revenue estimates in the U.S. suggest annual sales of $20-40 million, contingent on overdose case volume and adoption.
- No imminent biosimilar competition projected.
- Prices are likely to remain stable short-term, with slight downward pressure over the long term if biosimilar entry occurs.
FAQs
1. What factors influence the pricing of Vistogard?
Pricing is driven by manufacturing costs, hospital procurement negotiations, insurance reimbursement rates, and market demand for overdose treatments.
2. Are there any biosimilar or generic options for Vistogard?
As of now, no biosimilar or generic versions are approved or in late-stage development.
3. How prevalent are fluoropyrimidine overdoses?
Approximately 200-300 overdose cases occur annually in the U.S., primarily managed within hospital settings.
4. Will new formulations impact the market?
Potential new formulations could reduce costs or improve administration, influencing pricing and market penetration.
5. What is the outlook for market growth?
Market growth depends on increasing use of fluoropyrimidines and awareness campaigns. The antidote market remains a niche, with incremental growth expected.
References
- Food and Drug Administration (FDA). (2018). Vistogard (uridine triacetate) prescribing information. FDA.gov.
- MarketWatch. (2022). Oncology drug market size and forecast. MarketWatch.com.
- IQVIA. (2021). Trends in chemotherapy overdose incidents. IQVIA.com.
- EvaluatePharma. (2022). Oncology drugs market projections. EvaluatePharma.com.
- U.S. Department of Health and Human Services. (2020). Overdose management protocols. HHS.gov.
