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Serving leading biopharmaceutical companies globally:

Dow
Cantor Fitzgerald
Queensland Health
Farmers Insurance
Novartis
McKesson
Express Scripts
Teva
Boehringer Ingelheim
US Department of Justice

Generated: October 23, 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 fourteen patent family members in thirty-eight countries and sixty-four supplementary protection certificates in twelve countries.

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

Summary for Generic Name: alogliptin benzoate

US Patents:12
Tradenames:3
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 list26
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
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-002Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 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
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-006Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-003Jan 25, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
OSENI
alogliptin benzoate; pioglitazone hydrochloride
TABLET;ORAL022426-005Jan 25, 2013RXYesNo► Subscribe► Subscribe ► 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;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-002Jan 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;ORAL022271-003Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-001Jan 25, 2013► Subscribe► Subscribe
Takeda Pharms Usa
NESINA
alogliptin benzoate
TABLET;ORAL022271-003Jan 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
6,211,206 Pharmaceutical composition► Subscribe
6,599,923 Pharmaceutical composition► Subscribe
6,277,869 Pharmaceutical composition► Subscribe
6,172,090 Pharmaceutical composition► Subscribe
6,239,153 Pharmaceutical composition► Subscribe
5,952,356 Pharmaceutical composition► Subscribe
6,271,243 Pharmaceutical composition► Subscribe
6,150,384 Pharmaceutical composition► Subscribe
7,795,428Dipeptidyl peptidase inhibitors► Subscribe
6,232,330 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 Ingredient: alogliptin benzoate

Country Document Number Estimated Expiration
Russian Federation2189233► Subscribe
Czech Republic291624► Subscribe
South Korea20100036363► Subscribe
Argentina065096► Subscribe
Russian Federation2327455► Subscribe
European Patent Office1520582► Subscribe
Germany122007000002► Subscribe
Australia5603496► Subscribe
European Patent Office0896538► Subscribe
European Patent Office2574336► 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
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
0280Netherlands► Subscribe300280, 20170424, EXPIRES: 20220320
382Luxembourg► Subscribe91382, EXPIRES: 20220424
0861666/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
C 038/2006Ireland► SubscribeSPC 038/2006: 20070528, EXPIRES: 20210619
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
C/GB14/082United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
00708Netherlands► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
334Luxembourg► SubscribeCERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cantor Fitzgerald
Teva
Healthtrust
Julphar
McKesson
Johnson and Johnson
AstraZeneca
Citi
Fuji

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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