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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Harvard Business School
Daiichi Sankyo
Medtronic
QuintilesIMS
Cerilliant
Dow
Express Scripts
US Department of Justice

Generated: November 18, 2017

DrugPatentWatch Database Preview

NESINA Drug Profile

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Which patents cover Nesina, and what generic Nesina alternatives are available?

Nesina is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fourteen patent family members in thirty-eight countries and sixty-four supplementary protection certificates in twelve countries.

The generic ingredient in NESINA is alogliptin benzoate. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the alogliptin benzoate profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for NESINA

Drugname Dosage Strength RLD Submissiondate
alogliptinTablets6.25 mg, 12.5 mg and 25 mgNesina1/25/2017

Non-Orange Book Patents for Tradename: NESINA

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
6,133,293 Pharmaceutical composition► Subscribe
6,288,090 Pharmaceutical composition► Subscribe
6,225,326 Pharmaceutical composition► Subscribe
6,239,153 Pharmaceutical composition► Subscribe
7,538,125Pharmaceutical composition► Subscribe
6,211,205 Pharmaceutical composition► Subscribe
7,906,523Dipeptidyl peptidase inhibitors► Subscribe
6,323,225 Pharmaceutical composition► Subscribe
5,952,356 Pharmaceutical composition► Subscribe
6,218,409 Pharmaceutical composition► 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 Tradename: NESINA

Country Document Number Estimated Expiration
China102134231► Subscribe
European Patent Office1416932► Subscribe
China1530105► Subscribe
Norway20021172► Subscribe
TaiwanI344962► Subscribe
Czech Republic291624► Subscribe
China102127057► Subscribe
China1289082► Subscribe
New Zealand332707► Subscribe
Japan5284967► 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: NESINA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 5006-2014Slovakia► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
0280Netherlands► Subscribe300280, 20170424, EXPIRES: 20220320
C0013France► SubscribePRODUCT NAME: ALOGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/844 20130919
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
382Luxembourg► Subscribe91382, EXPIRES: 20220424
C0035France► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
0258Netherlands► Subscribe300258, 20160620, EXPIRES: 20210619
C/GB07/009United Kingdom► SubscribeSPC/GB07/009: 20070126
2014042Lithuania► SubscribePRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Boehringer Ingelheim
McKinsey
Cipla
Dow
Harvard Business School
Baxter
UBS
Cantor Fitzgerald
Express Scripts

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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