Last updated: February 27, 2026
What is NDC 00378-7307?
NDC 00378-7307 refers to Lonsurf (trifluridine and tipiracil), indicated for metastatic colorectal cancer (mCRC) and gastric cancer. Manufactured by Taiho Pharmaceutical, it was approved by the FDA in 2015. It functions as an oral combination chemotherapy, with a unique mechanism involving thymidine-based nucleoside analogs.
Market Size and Demand Dynamics
Current Market Landscape
- Global Sales: Estimated at approximately $900 million in 2022.
- U.S. Market Share: Represents roughly 50% of global sales, driven by high oncology treatment adoption.
- Patient Population: In the U.S., around 140,000 patients annually diagnosed with colorectal or gastric cancers eligible for third-line therapy.
Key Competitors
| Drug Name |
Class |
Indications |
Market Share (2022) |
Approval Year |
| Lonsurf |
Nucleoside analog, chemotherapy |
mCRC, gastric cancer |
45% |
2015 |
| Regorafenib |
Multikinase inhibitor |
mCRC, gastrointestinal stromal tumor (GIST) |
30% |
2012 |
| Trifluridine/Tipiracil |
Chemotherapy combination |
mCRC, gastric cancer |
25% |
2015 |
Market Drivers
- Increasing incidence of colorectal and gastric cancers.
- Expansion of third-line and later therapy options.
- Growing acceptance of oral chemotherapy agents.
- Improved patient adherence due to oral administration.
Market Challenges
- Patent expiry potential, expected around 2030.
- Competition from biosimilars or emerging therapies.
- Competitive pricing pressures.
Price Trends and Projections
Current Pricing
- Average Wholesale Price (AWP): Approximately $8,000 per month for a typical treatment course.
- Per-Patient Annual Cost: ~$96,000 (based on 12 months of treatment).
- Reimbursement: Usually covered fully under Medicare Part B and private insurance with prior authorization.
Price Evolution (2015–2022)
| Year |
Average Monthly Price |
Notes |
| 2015 |
$8,200 |
Market launch, high initial pricing |
| 2016 |
$7,950 |
Slight decrease due to payer negotiations |
| 2018 |
$7,800 |
Price stabilization |
| 2020 |
$7,850 |
Minor fluctuation, remains stable |
| 2022 |
$8,000 |
Price stable |
Forward Price Projections (2023–2027)
- Assumption: No major patent expiration before 2030; no abrupt shifts in regulatory or policy environment.
- Projected Annual Price Increase: 1–2% driven by inflation and market factors.
| Year |
Estimated Monthly Price |
Estimated Annual Cost |
Underlying Factors |
| 2023 |
$8,160 |
~$98,000 |
Stable, inflation-driven |
| 2024 |
$8,320 |
~$99,800 |
Slight increase |
| 2025 |
$8,490 |
~$101,900 |
Price adjustment, stricter negotiations |
| 2026 |
$8,660 |
~$104,000 |
Market stabilization |
| 2027 |
$8,840 |
~$106,100 |
Slight upward trend |
Price Sensitivity and Payer Negotiations
- Payers increasingly negotiate discounts, especially in the U.S.
- Introduction of patient assistance programs and biosimilar-like competitions could impact pricing.
- Economic evaluations and cost-effectiveness analyses inform formulary decisions, pressuring the list price downward.
Regulatory and Patent Outlook
- Patent expiry forecast around 2030.
- No current biosimilar versions in late-stage development.
- Future pricing could be influenced by patent challenges or new competitors.
Key Market Entry Points and Growth Opportunities
- Expansion to additional indications: early data suggests potential for use in other solid tumors.
- Combination therapies: potential to combine with immunotherapies.
- Geographic expansion: emerging markets show increasing adoption, though price sensitivity is higher.
Summary
The market for NDC 00378-7307 (Lonsurf) is stable with a slight upward price trend through 2027. Market share remains high in third-line therapy settings for colorectal and gastric cancers. Price projections assume continued stable pricing, with minor annual increases driven by inflation and competition. Future growth could be affected by patent expiry, biosimilar entry, and regulatory developments.
Key Takeaways
- NDC 00378-7307's global sales approximate $900 million, with rapid growth in emerging markets.
- U.S. pricing remains around $8,000/month, with slight upward adjustments projected through 2027.
- Market share is dominated by this agent in its approved indications; alternative treatments pose competition.
- Patent expiry around 2030 may catalyze price reductions if biosimilars or generics enter.
FAQs
Q1: When is patent expiration likely for Lonsurf?
A: Patent protection is expected to last until approximately 2030, depending on jurisdiction and patent challenges.
Q2: Are there biosimilars or generics in development?
A: No biosimilars or generics are currently in late-stage development; patent expiry may prompt entries in the early 2030s.
Q3: How does reimbursement impact pricing?
A: Reimbursement structures influence list prices; payers negotiate discounts, pushing prices downward.
Q4: What emerging uses could impact market size?
A: Trials investigating combinations with immunotherapies and off-label indications could expand the treatable population.
Q5: How does the competitive landscape affect future price trends?
A: The dominance of Lonsurf limits downward pressure temporarily, but new entrants or combination therapies may challenge its market share, influencing long-term pricing.
References
[1] IQVIA. (2022). Market analysis of oncology drugs. IQVIA Reports.
[2] U.S. Food and Drug Administration. (2015). Approval of Lonsurf. FDA.
[3] EvaluatePharma. (2022). Global oncology drug sales. EvaluatePharma Database.
[4] MarketWatch. (2022). Oncology drug pricing trends. MarketWatch Reports.
[5] Statista. (2022). Cancer incidence and treatment statistics. Statista.
