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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 three patents protecting this drug. Additional details are available on the LONSURF profile page.

The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.

Summary for NDA: 207981

Tradename:
LONSURF
Applicant:
Taiho Oncology
Ingredient:
tipiracil hydrochloride; trifluridine
Patents:3
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.14MG BASE;15MG
Approval Date:Sep 22, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Sep 22, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:5,744,475Patent Expiration:Mar 28, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented 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
Patent:6,479,500Patent Expiration:Mar 16, 2020Product Flag?Substance Flag?Delist Request?
Patented 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

Expired Orange Book Patents for NDA: 207981

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 20155,744,475► subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 20155,744,475► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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