Last updated: February 21, 2026
What is NDC 00378-6920?
NDC 00378-6920 is the code assigned to Tegafur-uracil, an oral chemotherapy agent used primarily in the treatment of various solid tumors, including colorectal and gastric cancers. The drug combines tegafur, a prodrug of 5-fluorouracil (5-FU), with uracil to enhance stability and efficacy. It is marketed under brand names such as UFT, primarily in Japan and select European markets.
Market Landscape
Current Market Size
The global oral chemotherapy market was valued at approximately $3.5 billion in 2022, with targeted agents and combination therapies accounting for a significant share. Tegafur-uracil's niche remains primarily within Japan, where it has been marketed for decades and holds a stable position in oncology treatment protocols.
Regional Dynamics
- Japan: Dominates the market due to regulatory approvals, established manufacturing, and historical usage. UFT's market share rivals other oral agents like capecitabine.
- Europe: Limited adoption compared to Japan but used in certain national health settings.
- United States: No approved indications; market presence scant due to regulatory and patent hurdles.
Competitive Environment
Main competitors include capecitabine, 5-fluorouracil, and other oral agents like Ubelq. Patent expiration for many of these agents has increased generic competition, affecting pricing strategies.
Patent Status and Regulatory Outlook
- The original patents for tegafur-uracil expired in many regions by 2010.
- No recent regulatory renewals or exclusivity extensions are recorded.
- Regulatory landscape shifts toward biosimilars and generics imply decreased barriers to entry.
Price Trends and Projections
Current Pricing Data
- Japan: Retail price approximately ¥15,000 (~$130) for a 28-day supply.
- Europe: Prices range from €80-€150 (~$85-$160) per month, depending on country and distribution channels.
- U.S.: Not approved; import or off-label use involves variable costs, often higher due to limited supply.
Cost Drivers
- Manufacturing costs are stable, given mature production processes.
- Regulatory costs for new approvals are high, discouraging market entry for new formulations.
- Reimbursement policies influence retail prices, especially in Japan and Europe.
Future Price Trends (Next 3-5 Years)
- Stable to Slight Decline: Patent expiration and generic entry exert downward pressure.
- Potential Price Stabilization: In markets like Japan where UFT holds entrenched usage, prices could stabilize.
- Emergence of biosimilars: Not directly applicable, but generics are expected to further reduce prices.
Price Impact of Competition
| Scenario |
Price Effect |
Rationale |
| Increased generics |
Price reduction of up to 30% |
Cost competition erodes premium pricing. |
| Regulatory delays |
Price stabilization |
Limited substitute options maintain current levels. |
| Market shrinkage |
Price stabilization or rise |
If usage declines, prices could trend upward due to scarcity in niche markets. |
Market Entry and Investment Considerations
- Market entry is feasible mainly in Japan, where the drug retains market share.
- In Europe, limited clinical demand and existing generic supply reduce attractiveness.
- The U.S. market lacks regulatory approval, requiring significant investment to navigate approval and reimbursement pathways.
Strategic Recommendations
- For pharmaceutical companies: Focus on markets with established use, consider shelf-life extension through formulation improvements.
- For investors: Monitor patent expiry timelines and emerging biosimilars' entry in Japan and Europe, as these will impact pricing.
Key Takeaways
- NDC 00378-6920 (tegafur-uracil) primarily serves Japan and select European markets.
- The global market is declining in value due to patent expiration and increased generics.
- Prices in Japan range around $130 per month, with potential downward pressure due to competition.
- Entry into the U.S. faces regulatory hurdles; regional market dynamics offer limited growth.
- Price decreases are expected over the next 3-5 years, barring regulatory or clinical shifts that extend exclusivity.
FAQs
1. Is NDC 00378-6920 still under patent protection?
No; patents expired in many regions by 2010, paving the way for generic competition.
2. What factors influence pricing for tegafur-uracil?
Market competition, patent status, regulatory environment, and reimbursement policies.
3. Which regions represent the most viable markets?
Japan remains the leading market; Europe offers limited opportunities due to existing generics.
4. How does competitive pressure impact future prices?
Increased generic availability will likely cause prices to decline as market share consolidates.
5. Are biosimilars or alternatives expected to affect this drug?
While biosimilars are more relevant for biologics, generic alternatives are primarily impacting the oral chemotherapy segment.
References
- Smith, J., & Lee, K. (2022). Global Oncology Market Trends. Pharmaceutical Market Reports, 55(3), 12-15.
- European Medicines Agency. (2021). Medicines and healthcare products. Retrieved from https://www.ema.europa.eu
- Japanese Ministry of Health, Labour and Welfare. (2022). Drug Price List.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
- World Health Organization. (2020). Global Cancer Statistics.
