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Serving 500+ biopharmaceutical companies globally:

Deloitte
Express Scripts
Merck
Chubb
Moodys
Citi
Cerilliant
Queensland Health
US Army
McKesson

Generated: August 18, 2017

DrugPatentWatch Database Preview

Alogliptin benzoate - Generic Drug Details

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What are the generic sources for alogliptin benzoate and what is the scope of alogliptin benzoate patent protection?

Alogliptin benzoate
is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa and is included in three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate has two hundred and three patent family members in thirty-eight countries.

There are nine drug master file entries for alogliptin benzoate. Two suppliers are listed for this compound.

Summary for Generic Name: alogliptin benzoate

Tradenames:3
Patents:12
Applicants:1
NDAs:3
Drug Master File Entries: see list9
Suppliers / Packagers: see list2
Bulk Api Vendors: see list32
Clinical Trials: see list75
Patent Applications: see list23
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:alogliptin benzoate at DailyMed

Pharmacology for Ingredient: alogliptin benzoate

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
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 2013RXYesNo► Subscribe► SubscribeYY ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-004Jan 25, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-001Jan 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alogliptin benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: alogliptin benzoate

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
6,172,090 Pharmaceutical composition► Subscribe
6,169,099 Pharmaceutical composition► Subscribe
6,384,062 Pharmaceutical composition► Subscribe
5,952,356 Pharmaceutical composition► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► 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: alogliptin benzoate

Country Document Number Estimated Expiration
South Korea20070008620► Subscribe
Japan4068118► Subscribe
Eurasian Patent Organization200601701► Subscribe
Portugal861666► Subscribe
JapanH0967271► 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: ALOGLIPTIN BENZOATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
0258Netherlands► Subscribe300258, 20160620, EXPIRES: 20210619
1084705/01Switzerland► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Deloitte
Healthtrust
McKinsey
Cipla
US Department of Justice
Dow
Cerilliant
Teva
Johnson and Johnson

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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ISSN: 2162-2639

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