Generic Lonsurf Availability

Last updated on Apr 10, 2025.

Lonsurf is a brand name of tipiracil/trifluridine, approved by the FDA in the following formulation(s):

LONSURF (tipiracil hydrochloride; trifluridine - tablet;oral)

Manufacturer: TAIHO ONCOLOGY
Approval date: September 22, 2015
Strength(s): EQ 6.14MG BASE;15MG ^[RLD] ^[AB], EQ 8.19MG BASE;20MG ^[RLD] ^[AB]

Is there a generic version of Lonsurf available?

A generic version of Lonsurf has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Lonsurf and have been approved by the FDA:

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE (tipiracil hydrochloride; trifluridine tablet;oral)

Manufacturer: MSN
Approval date: January 8, 2025
Strength(s): EQ 6.14MG BASE;15MG ^[AB], EQ 8.19MG BASE;20MG ^[AB]
Manufacturer: NATCO
Approval date: June 13, 2023
Strength(s): EQ 6.14MG BASE;15MG ^[AB], EQ 8.19MG BASE;20MG ^[AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Lonsurf. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Method for treating cancer patients with severe renal impairment
Patent 10,456,399
Issued: October 29, 2019
Inventor(s): Yoshida Kenichiro
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
A method for treating cancer in patients with creatinine clearance of 15 mL/min or more and less than 30 mL/min, including dividing a combination drug containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5, in a dose of 30 to 50 mg/m/day as FTD-equivalent, into two to four times a day, and orally administering it to the patient.
Patent expiration dates:
- February 3, 2037
  ✓
  Patent use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY
- February 3, 2037
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  Patent use: TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent 10,457,666
Issued: October 29, 2019
Inventor(s): Kazuno Hideki & Mutsumi Tomonobu
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
Crystal Form I of 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione hydrochloride exhibiting powder X-ray peaks at two or more angles selected from the group consisting of 11.6°, 17.2°, 17.8°, 23.3°, 27.1°, and 29.3° as a diffraction angle (2θ±0.2°).
Patent expiration dates:
- June 17, 2034
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  Drug substance
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Method for treating cancer patients with severe renal impairment
Patent 10,960,004
Issued: March 30, 2021
Inventor(s): Yoshida Kenichiro
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
A method for treating cancer in patients with creatinine clearance of 15 mL/min or more and less than 30 mL/min, including dividing a combination drug containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride in a molar ratio of 1:0.5, in a dose of 30 to 50 mg/m/day as FTD-equivalent, into two to four times a day, and orally administering it to the patient.
Patent expiration dates:
- February 3, 2037
  ✓
  Patent use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY
- February 3, 2037
  ✓
  Patent use: TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
Stable crystal form of tipiracil hydrochloride and crystallization method for the same
Patent 9,527,833
Issued: December 27, 2016
Inventor(s): Kazuno Hideki & Mutsumi Tomonobu
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
An objective of the present invention is to obtain a stable crystal form of 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione hydrochloride. The present invention provides a crystal of 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione hydrochloride exhibiting characteristic peaks at angles of 11.6°, 17.2°, 17.8°, 23.3°, 27.1°, and 29.3° as a diffraction angle (2θ±0.1°) in powder X-ray diffraction.
Patent expiration dates:
- June 17, 2034
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Antitumor agent and antitumor effect enhancer
Patent 9,943,537
Issued: April 17, 2018
Inventor(s): Okabe Hiroyuki
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
Provided is a novel method for treating a cancer using an FTD/TPI combination drug, which shows remarkably excellent antitumor effect and small adverse effects.
Patent expiration dates:
- September 5, 2034
  ✓
  Patent use: TREATMENT OF METASTATIC COLORECTAL CANCER WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY
Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor
Patent RE46284
Issued: January 24, 2017
Inventor(s): Emura Tomohiro & Mita Akira
Assignee(s): TAIHO PHARMACEUTICAL CO., LTD.
The present invention relates to a method for treating a cancer comprising orally administering a composition containing α,α,α-trifluorothymidine (FTD) and 5-chloro-6-(1-(2-iminopyrrolidinyl)methyl)uracil hydrochloride in a molar ratio of 1:0.5 at a dose of 20 to 80 mg/m/day in terms of FTD in 2 to 4 divided portions per to patients in need of the treatment.
Patent expiration dates:
- September 22, 2029
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  Patent use: TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER 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
- September 22, 2029
  ✓
  Patent use: TREATMENT OF ADULTS WITH METASTATIC GASTRIC OR GJA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, EITHER A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY
- September 22, 2029
  ✓
  Patent use: TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN-BASED CHEMOTHERAPY, AN ANTI-VEGF BIOLOGICAL THERAPY, AND IF RAS WILD-TYPE, AN ANTI-EGFR THERAPY

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- February 22, 2026 - TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY

More about Lonsurf (tipiracil / trifluridine)

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB	Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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Images

Pill 102 20 mg 20 is Lonsurf tipiracil hydrochloride 8.19 mg (base) / trifluridine 20 mg — Lonsurf tipiracil hydrochloride 8.19 mg (base) / trifluridine 20 mg (102 20 mg 20)