Last updated: February 16, 2026
What is the drug associated with NDC 46122-0738?
NDC 46122-0738 corresponds to Lonsurf (trifluridine and tipiracil). It is an oral chemotherapy agent approved by the FDA for metastatic colorectal cancer and gastric cancer.
Current Market Landscape
Lonsurf is marketed by Taiho Pharmaceutical and its U.S. partner, Taiho Oncology. It became commercially available after receiving FDA approval in 2015 for colorectal cancer and in 2019 for gastric cancer indications.
Market Size and Growth Drivers
| Parameter |
Data |
| U.S. Medicare/Medicaid spending (2019–2022) |
Estimated at $300M annually for colorectal and gastric cancers (IQVIA, 2022) |
| Number of annual new colorectal cancer diagnoses in the U.S. |
~146,000 (American Cancer Society, 2022) |
| Market penetration |
Approx. 60% in eligible patients, with room for growth due to expanded indications and line-of-therapy use |
Growth is driven by:
- Increasing prevalence of colorectal and gastric cancers, especially among aging populations.
- Expansion of indications; approval for later-line therapy due to clinical trial success.
- Competitive landscape with limited oral chemotherapy options for these indications.
Competitive Context
Primary competitors include:
- FOLFOX (oxaliplatin-based regimens)
- FOLFIRI (irinotecan-based regimens)
- Other targeted therapies (e.g., bevacizumab, ramucirumab)
Lonsurf’s advantages include oral administration and manageable safety profile, favoring patient adherence.
Price Trends and Projections
Current Pricing (2023):
- Average wholesale price (AWP): Approximately $10,000–$12,000 per month.
- Actual transaction prices (net prices): Estimated at $7,000–$9,000 per month after rebates and discounts.
Historical Pricing Trends:
- Upon launch in 2015, monthly wholesale prices were around $9,500.
- Slight price reductions observed by 2018-2020, related to generic competition for other chemotherapeutics and negotiated rebates.
Future Price Projections:
| Year |
Estimated Wholesale Monthly Price |
Notes |
| 2024 |
$9,500 |
Stable, given patent exclusivity persists. |
| 2025 |
$9,000–$9,500 |
Slight decrease possible, driven by payer negotiations. |
| 2026+ |
$8,500–$9,000 |
Potential if biosimilar or generic versions emerge, or reimbursement models shift. |
Patent Status and Biosimilar Outlook
- Patent exclusivity is expected to last until at least 2028.
- Biosimilars or generics could enter the market post-exclusivity, causing downward price pressure.
- No biosimilar currently approved for Lonsurf; patent litigation could influence timing.
Regulatory and Policy Factors Impacting Pricing
- Pricing transparency laws: Increasing pressure on pharmaceutical pricing.
- Reimbursement policies: Payer negotiations significantly influence net prices.
- Value-based pricing initiatives: Emphasize outcomes, possibly restricting price increases.
Key Markets Beyond the U.S.
- European markets exhibit similar pricing patterns, adjusted for local pricing regulations.
- Emerging markets likely to see lower prices due to access and affordability considerations.
Conclusions
Lonsurf’s market is mature but stable, with high prescription volumes driven by late-line colorectal and gastric cancers. Price points are unlikely to change dramatically before patent expiration; however, biosimilar entry could pressure prices downward.
Key Takeaways
- The drug’s annual U.S. sales are estimated at approximately $300 million, with potential for growth through expanded indications.
- Current monthly gross prices hover around $10,000, with net prices around $7,000–$9,000.
- Price stability is expected until patent expiry around 2028; afterward, biosimilar competition could lower prices.
- Payer negotiations and regulatory policies remain key influences on net pricing.
- Market growth hinges on increasing cancer prevalence and the drug’s positioning as a preferred oral therapy.
FAQs
Q1: How does Lonsurf compare price-wise to other chemotherapy options?
A: Lonsurf’s monthly gross price of around $10,000 is higher than some traditional chemotherapies (e.g., capecitabine) but offers convenience and oral administration benefits, influencing payer and patient preferences.
Q2: What factors could accelerate the entry of biosimilars or generics?
A: Patent expiry around 2028, legal challenges, or regulatory decisions could permit biosimilar development, increasing competitive pressure.
Q3: Are there geographical price differences for Lonsurf?
A: Yes. The U.S. maintains higher prices due to market size and patent protections, whereas other regions like Europe may see lower prices due to regulatory controls.
Q4: How do reimbursement policies influence market prices?
A: Payer negotiations and value-based rebate models often reduce net prices, especially amid rising healthcare cost containment efforts.
Q5: What is the outlook for Lonsurf’s market share?
A: Likely stable in the near term, with potential growth through indication expansion. Competition and biosimilar entry post-2028 could alter the landscape.
References
[1] IQVIA. "U.S. Oncology Market Trends 2022."
[2] American Cancer Society. "Cancer Statistics, 2022."
[3] FDA. "Lonsurf Approval Documents," 2015 and 2019.
