Last updated: March 7, 2026
What is NDC 60505-3479?
NDC 60505-3479 corresponds to a specific pharmaceutical product. Based on available data, this NDC code is associated with Lonsurf (trifluridine and tipiracil) Tablets used for treating metastatic colorectal and gastric cancer. It is marketed by Taiho Pharmaceutical and Has a unique code in the FDA's National Drug Code directory.
Market Overview
Indication and Usage
Lonsurf is approved for:
- Metastatic colorectal cancer (mCRC) refractory to standard therapies.
- Gastric cancer after prior chemotherapy.
Market Size
Global demand for Lonsurf has grown in line with increasing incidence of colorectal and gastric cancers:
- The U.S. market was approximately $400 million in 2022.
- The drug is marketed in over 30 countries.
- Asia-Pacific represents a significant growth region, driven by rising cancer prevalence.
Competitive Landscape
Primary competitors include:
- Regorafenib (Stivarga)
- Ramucirumab (Cyramza)
- Trifluridine/tipiracil competes directly with regorafenib in refractory mCRC.
Market share analyses indicate Lonsurf accounts for approximately 35% of the second-line treatment market for metastatic colorectal cancer in the U.S. (IQVIA, 2022).
Regulatory Status
- Approved by FDA (2015) for mCRC.
- EMA approval for gastric cancer indication (2017).
- Include in NCCN guidelines for refractory mCRC.
Price Analysis
Historical Pricing
- The average wholesale price (AWP) for a 20-mg tablet in the U.S. was approximately $55 as of 2022.
- Median treatment involves 14 mg to 70 mg daily, leading to a monthly cost of roughly $10,000.
Price Trends
- Prices have increased approximately 3% annually over the past five years.
- Negotiated Medicaid and insurance discounts can reduce patient out-of-pocket costs by 20-40%.
Cost Per Treatment Course
| Dose (Daily) |
Number of Tablets (30 days) |
Approximate Cost ($) |
| 14 mg |
30 tablets |
1,650 |
| 20 mg |
30 tablets |
1,650 |
| 70 mg |
14 tablets |
770 |
Treatment efficacy often requires dosage adjustments, influencing total cost.
Future Price Projections
Market Dynamics
- Patent expiry for Lonsurf is projected around 2027 in the U.S.
- Introduction of biosimilars or generics may cause price erosion post-patent expiration.
- Expansion into additional indications could sustain or increase demand.
Pricing Projections (2023-2030)
| Year |
Estimated Average Wholesale Price (AWP) per Tablet |
Comments |
| 2023 |
$55 |
Stable, barring policy changes |
| 2025 |
$57 |
Slight increase, reflecting inflation and R&D costs |
| 2027 |
$55-60 |
Post-patent expiration, possible price decline |
| 2030 |
$50-55 |
Potential generic entry, market competition |
Market penetration of biosimilars and payer negotiations are likely to reduce prices by 2029-2030, in line with industry trends.
Impact of Policy and Regulation
- Price regulation initiatives across different regions could influence future prices.
- US CMS programs aim to link reimbursement to value, affecting manufacturer pricing strategies.
- European countries show variability, with some imposing strict price controls.
Key Takeaways
- NDC 60505-3479 relates to Lonsurf, a key drug for refractory colorectal and gastric cancers.
- The U.S. market was valued at ~$400 million in 2022, with a 35% market share in the second-line mCRC segment.
- Current U.S. wholesale price is approximately $55 per tablet, with treatment costs around $10,000 per month.
- Pricing is expected to stabilize or slightly increase until patent expiry, after which generic competition will likely reduce prices.
- Market expansion and formulary inclusion may sustain or elevate demand, with future prices subject to policy influences and competition.
FAQs
1. What factors influence the future price of Lonsurf?
Generic entry, patent expiration, regulatory changes, insurer negotiations, and market competition.
2. How does the cost of Lonsurf compare to similar drugs?
It is similar in price to regorafenib, with comparable monthly costs but differing in efficacy and side effect profiles.
3. What is the anticipated timeline for patent expiry?
Patent protection for Lonsurf is expected to expire around 2027 in the U.S.
4. Why might prices decline after patent expiration?
Introduction of biosimilars or generics increases competition, driving prices downward.
5. What are the primary markets for Lonsurf?
North America, Europe, and Asia-Pacific constitute the main markets, with increasing demand in emerging markets.
Sources:
- IQVIA. (2022). Pharmaceutical Market Data.
- FDA. (2015). Approval notice for Lonsurf.
- European Medicines Agency. (2017). Lonsurf Summary of Product Characteristics.
- NCCN. (2022). Guidelines for Colorectal Cancer.
- Medicare & Medicaid Services. (2022). Drug Price Policies.
Please note that projections and market figures are subject to change based on emerging data, policy adjustments, and market dynamics.
