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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 207981


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NDA 207981 describes LONSURF, which is a drug marketed by Taiho Oncology and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the LONSURF profile page.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
Summary for 207981
Tradename:LONSURF
Applicant:Taiho Oncology
Ingredient:tipiracil hydrochloride; trifluridine
Patents:6
Pharmacology for NDA: 207981
Suppliers and Packaging for NDA: 207981
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981 NDA Taiho Pharmaceutical Co., Ltd. 64842-1020 64842-1020-1 20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1)
LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981 NDA Taiho Pharmaceutical Co., Ltd. 64842-1020 64842-1020-2 40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.14MG BASE;15MG
Approval Date:Sep 22, 2015TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Feb 22, 2026
Regulatory Exclusivity Use: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
Patent:⤷  Sign UpPatent Expiration:Feb 3, 2037Product Flag?Substance Flag?Delist Request?
Patented 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
Patent:⤷  Sign UpPatent Expiration:Feb 3, 2037Product Flag?Substance Flag?Delist Request?
Patented 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

Expired US Patents for NDA 207981

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-002 Sep 22, 2015 ⤷  Sign Up ⤷  Sign Up
Taiho Oncology LONSURF tipiracil hydrochloride; trifluridine TABLET;ORAL 207981-001 Sep 22, 2015 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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