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Alogliptin benzoate; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for alogliptin benzoate; metformin hydrochloride?

Alogliptin benzoate; metformin hydrochloride is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; metformin hydrochloride has two hundred and nineteen patent family members in forty-two countries.

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

Summary for Generic Name: alogliptin benzoate; metformin hydrochloride

Tradenames:1
Patents:10
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list2
Clinical Trials: see list1,721
Drug Prices:see low prices
DailyMed Link:alogliptin benzoate; metformin hydrochloride at DailyMed

Pharmacology for Ingredient: alogliptin benzoate; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 2013RXYesNo8,288,539► SubscribeY ► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-002Jan 25, 2013RXYesYes7,807,689► SubscribeYY ► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 2013RXYesNo► Subscribe► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-002Jan 25, 2013RXYesYes6,890,898► Subscribe ► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-002Jan 25, 2013RXYesYes6,303,661► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: alogliptin benzoate; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-002Jan 25, 20135,965,584► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20136,166,043► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20136,329,404► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20136,150,383► Subscribe
Takeda Pharms Usa
KAZANO
alogliptin benzoate; metformin hydrochloride
TABLET;ORAL203414-001Jan 25, 20135,965,584► Subscribe
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Non-Orange Book Patents for Generic Ingredient: alogliptin benzoate; metformin hydrochloride

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
8,188,275Dipeptidyl peptidase inhibitors► Subscribe
6,172,089 Pharmaceutical composition► Subscribe
6,218,409 Pharmaceutical composition► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,384,062 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; metformin hydrochloride

Country Document Number Estimated Expiration
South Africa9605190► Subscribe
Germany69637988► Subscribe
Portugal1174135► Subscribe
Japan2017008092► Subscribe
Japan2002501889► 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; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00705Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0308Netherlands► Subscribe300308, 20170424, EXPIRES: 20220423
14/012Ireland► SubscribePRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
C0008France► SubscribePRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
90014-6Sweden► SubscribePRODUCT NAME: ALOGLIPTIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/844 20130919
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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 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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