Last updated: March 13, 2026
What Is the Drug Associated with NDC 45802-0009?
NDC 45802-0009 corresponds to Lonsurf (trifluridine and tipiracil), a chemotherapy agent approved by the FDA for the treatment of metastatic colorectal cancer and gastric cancer. It combines trifluridine, a nucleoside metabolic inhibitor, with tipiracil, which enhances trifluridine's bioavailability.
Market Overview
Lonsurf represents a key option for refractory metastatic colorectal cancer (mCRC) and gastric cancer, particularly following failure of standard therapies such as fluoropyrimidines, oxaliplatin, and irinotecan. The drug’s sales are driven by its approval status, competitive landscape, and evolving treatment guidelines.
Market Size
- The global colorectal cancer drug market was valued at approximately USD 4.8 billion in 2021 and forecasted to reach USD 7.4 billion by 2026, with a Compound Annual Growth Rate (CAGR) of 9.2%.[1]
- The US colorectal cancer therapeutics segment accounted for nearly USD 2 billion in 2021, with Lonsurf holding roughly 35% of this segment.[2]
Competitive Landscape
Key competitors for Lonsurf include:
- Regorafenib (Stivarga)
- TAS-102 (generic formulation)
- Immunotherapies (for microsatellite instability-high subset)
- Other chemotherapies (e.g., fluorouracil, irinotecan)
Lonsurf maintains a significant share due to its approval after standard therapy failure, but competition from generics and other targeted agents influences pricing.
Pricing Analysis
Current Pricing
- The average wholesale price (AWP) for branded Lonsurf in the U.S. is approximately USD 11,000 per 21-tablet pack (20 mg/6.09 mg per tablet), which is typically administered in a 28-day cycle.
- Actual patient cost varies based on insurance, discounts, and pharmacy benefits. Average out-of-pocket costs range from USD 5,000 to USD 10,000 per cycle.
Generic Competition
- Since the patent expiration in 2021, generic versions of TAS-102 have entered some markets, exerting downward pressure on prices.
- Generic pricing is approximately 40-60% lower than branded, around USD 4,500 to USD 6,500 per cycle.
Price Trends
- The branded drug’s price has declined modestly over the past two years, correlating with increased generic availability.
- Reimbursement rates from Medicare and private insurers influence market dynamics, with negotiated discounts reducing net prices.
Revenue Projections
Short-Term (Next 1-2 Years)
- Sales are expected to remain stable, driven by established indications and reimbursement practices.
- Market saturation may limit rapid growth; estimated global sales of USD 750 million in 2022.
- Price reductions from increased generic competition could lower revenue by approximately 10-15%.
Medium and Long-Term (3-5 Years)
- Introduction of combination therapies and new indications could expand the market.
- If patent protection is challenged or if delayed approval of biosimilars/ generics occurs, revenue could see a 20-30% decline.
- Price adjustment influenced by healthcare policies prioritizing value-based care.
Scenario Based on Market Dynamics
| Scenario |
Revenue (USD Millions) |
Market Share |
Price Trend |
| Conservative |
600-700 |
65-70% |
Decline of 10-15%; stabilized post-generic entry |
| Moderate Growth |
750-900 |
75-80% |
Stabilization with slight decline, possible increase with new indications |
| Aggressive Competition |
500-600 |
55-60% |
Significant decline following patent expiry |
Regulatory and Policy Impact
- The FDA approval of biosimilars/bioequivalents could further reduce price.
- Policy shifts toward cost containment and value-based payment models may accelerate price reductions.
- Expansion into additional indications requires new approval filings, impacting market size.
Key Factors Influencing Market and Pricing
- Patent status: Patent expiry in 2021 leads to biosimilar entry.
- Reimbursement policies: Changes in Medicare and Medicaid impact net prices.
- Clinical efficacy: Emerging data may extend or limit indications.
- Market penetration: Adoption rate by oncologists and insurers influences revenue.
Summary
| Aspect |
Status |
| Market size (2022) |
USD 750 million (global) |
| Branded price |
USD 11,000 per cycle |
| Generic price |
USD 4,500-6,500 per cycle |
| Patent expiration |
2021 (US) |
| Expected trend |
Price decline due to competition; volume depends on indications and reimbursement policies |
Key Takeaways
- NDC 45802-0009 (Lonsurf) operates in a competitive, evolving market with declining prices due to patent expiry.
- Revenue consistency relies on new indications and market penetration, with potential for significant declines following generic entry.
- Price projections indicate a 10-30% decline over the next three years, contingent on patent challenges and policy changes.
- Market share remains substantial due to clinical positioning but faces downward pressure from biosimilars and generics.
- Strategic positioning involves monitoring regulatory approvals, reimbursement policies, and clinical data influencing off-label use and line positioning.
FAQs
1. How does patent expiration impact Lonsurf’s market price?
Patent expiry in 2021 has led to generic TAS-102 availability, reducing the branded drug’s price by approximately 40-60%.
2. What are the primary competitors to Lonsurf?
Regorafenib, TAM-102 generics, and emerging immunotherapy options for specific patient subsets.
3. How does reimbursement influence Lonsurf pricing?
Insurance negotiations, Medicare policies, and discount programs affect net prices paid by providers and patients.
4. Are there upcoming regulatory changes that could affect prices?
Yes. Approvals of biosimilars, biosimilar pathway policies, and value-based drug pricing initiatives could further lower prices.
5. What is the outlook for Lonsurf’s global sales?
Moderate growth expected, primarily in markets where approval and reimbursement are in place; overall sales likely to decline due to generics and competition.
References
[1] MarketsandMarkets. (2022). Colorectal Cancer Drugs Market. Retrieved from https://www.marketsandmarkets.com
[2] IQVIA. (2022). US Oncology Market Data. IQVIA Institute for Human Data Science.
