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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

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 five 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:5
Generic Entry Opportunity Date for 207981
Generic Entry Date for 207981*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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)
Paragraph IV (Patent) Challenges for 207981
Tradename Dosage Ingredient NDA Submissiondate
LONSURF TABLET;ORAL tipiracil hydrochloride; trifluridine 207981 2019-09-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 6.14MG BASE;15MG
Approval Date:Sep 22, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 22, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 22, 2022
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
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

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

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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 verification 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.