Prescription medicine
Tipiracil and trifluridine Brand names: Lonsurf
Tipiracil and trifluridine (Lonsurf) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tipiracil and trifluridine FDA label on DailyMed (effective November 5, 2025, Taiho Pharmaceutical Co., Ltd.); the NDA 207981 record on Drugs@FDA; every tipiracil and trifluridine label on DailyMed.
Highlights of the record
FDA label of November 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type
Forms and strengths
- 15 mg / 6.14 mg
- 20 mg / 8.19 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 22, 2015 Lonsurf, Taiho Oncology; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first June 13, 2023; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 3, 2037 Lonsurf tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10,666 through July 30, 2026
What is tipiracil and trifluridine used for?
From the label: indications and usageLONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: metastatic colorectal cancer as a single agent or in combination with bevacizumab who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. […]
Conditions named in the indications of tipiracil and trifluridine's FDA labels, with every medicine labeled for each:
From other tipiracil and trifluridine labelsColorectal cancer: Metastatic Colorectal Cancer LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and …
FDA pharmacologic class: Nucleoside Analog Antiviral, Nucleoside Metabolic Inhibitor and Thymidine Phosphorylase Inhibitor.
Source: FDA drug label (LONSURF), Taiho Pharmaceutical Co., Ltd., effective November 5, 2025 (SPL set f5beed22-d71d-4c0d-8dca-2c7317d65d85), via openFDA; the full label on DailyMed
What does the patient leaflet for tipiracil and trifluridine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LONSURF?Your healthcare provider should do blood tests before you receive LONSURF, at day 15 during treatment with LONSURF, and as needed to check your blood cell counts. LONSURF may cause serious side effects, including: Low blood cell counts. Low blood counts are common with LONSURF and can sometimes be severe and life-threatening. LONSURF can cause a decrease in your white blood cells, red blood cells, and platelets. Low white blood cells can make you more likely to get serious infections that could lead to death. Your healthcare provider may: lower your dose of LONSURF or stop LONSURF if you have low white blood cell or low platelet counts. Tell your healthcare provider right away if you get any of the following signs and symptoms of infection during treatment with LONSURF: fever chills body aches See “ What are the possible side effects of LONSURF? ” for more information about side effects.
From the patient leaflet: How should I store LONSURF?Store LONSURF at room temperature between 68°F and 77°F (20°C and 25°C). If you store LONSURF outside of the original bottle, throw away (dispose of) any unused LONSURF tablets after 30 days. Talk to your healthcare provider about how to safely dispose of LONSURF. Keep LONSURF and all medicines out of the reach of children.
Source: FDA drug label (LONSURF), Taiho Pharmaceutical Co., Ltd., effective November 5, 2025 (SPL set f5beed22-d71d-4c0d-8dca-2c7317d65d85), via openFDA; the full label on DailyMed
Is there a generic for tipiracil and trifluridine (Lonsurf)?
The FDA approved the first generic tipiracil and trifluridine on June 13, 2023. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 6 patents for Lonsurf tablets: the compound patent runs to June 17, 2034, and the last listed entry to February 3, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2023 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tipiracil and trifluridine label say about other medicines?
The tipiracil and trifluridine label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bevacizumab | warnings and precautions | In the 246 patients who received LONSURF in combination with bevacizumab, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4) consisting of neutropenia (52%), anemia (5%), thrombocytopenia (4%) and febrile neutropenia (0.4%). |
Source: FDA drug label (LONSURF), Taiho Pharmaceutical Co., Ltd., effective November 5, 2025 (SPL set f5beed22-d71d-4c0d-8dca-2c7317d65d85), via openFDA; the full label on DailyMed
What do FAERS reports show for tipiracil and trifluridine?
The FDA Adverse Event Reporting System holds 10,666 reports that list tipiracil and trifluridine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,219 are coded as a death and 2,932 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tipiracil and trifluridine?
4 other medicines are given the same way (oral) and in the same FDA class as tipiracil and trifluridine or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Capecitabine | Colorectal cancer | 18 labelers | $0.456 per tablet 500 mg tablet | No current entry |
| Fruquintinib | Colorectal cancer | none listed | n/a | No current entry |
| Encorafenib | Colorectal cancer | none listed | n/a | No current entry |
| Regorafenib | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as tipiracil and trifluridine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tipiracil and trifluridine
- 4 medicines for the same use
- Other nucleoside analog antivirals
- the pharmacologic class, with prices and generics
- Tipiracil and trifluridine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other