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Serving leading biopharmaceutical companies globally:

Dow
Citi
Julphar
Healthtrust
Chubb
Deloitte
Merck
Teva
Baxter
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Tipiracil hydrochloride; trifluridine - Generic Drug Details

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What are the generic drug sources for tipiracil hydrochloride; trifluridine and what is the scope of tipiracil hydrochloride; trifluridine freedom to operate?

Tipiracil hydrochloride; trifluridine
is the generic ingredient in one branded drug marketed by Taiho Oncology and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tipiracil hydrochloride; trifluridine has forty-nine patent family members in twenty-two countries and four supplementary protection certificates in four countries.

There is one drug master file entry for tipiracil hydrochloride; trifluridine. One supplier is listed for this compound.

Summary for tipiracil hydrochloride; trifluridine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 2015RXYesNo► Subscribe► SubscribeYY ► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tipiracil hydrochloride; trifluridine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-001Sep 22, 2015► Subscribe► Subscribe
Taiho Oncology
LONSURF
tipiracil hydrochloride; trifluridine
TABLET;ORAL207981-002Sep 22, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: tipiracil hydrochloride; trifluridine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,799,783Method of administrating an anticancer drug containing .alpha., .alpha., .alpha.-trifluorothymidine and thymidine phosphorylase inhibitor► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: tipiracil hydrochloride; trifluridine

Country Document Number Estimated Expiration
Denmark1080726► Subscribe
European Patent Office1849470► Subscribe
Denmark1849470► Subscribe
Russian Federation2007132181► Subscribe
Japan5576591► Subscribe
China1144587► Subscribe
Germany60027369► Subscribe
Australia3192800► Subscribe
Australia2014282281► Subscribe
JapanWO2006080327► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0889Netherlands► SubscribePRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACIL OF EEN ZOUT VAN TIPIRACIL, ZOALS TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
2017 00036Denmark► SubscribePRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
2017000052Germany► SubscribePRODUCT NAME: TRIFLURIDIN IN KOMBINATION MIT TIPIRACIL ODER EINEM SALZ VON TIPIRACIL WIE TIPIRACIL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1096 20160425
2017024Lithuania► SubscribePRODUCT NAME: TRIFLURIDINAS/TIPIRACILAS; REGISTRATION NO/DATE: EU/1/16/1096 20160425
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Covington
Harvard Business School
Fish and Richardson
Chinese Patent Office
Accenture
Cerilliant
Deloitte
Colorcon

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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