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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Cipla
Boehringer Ingelheim
McKesson
Chubb
Cantor Fitzgerald
Medtronic
Fish and Richardson

Generated: July 23, 2018

DrugPatentWatch Database Preview

Alogliptin benzoate; metformin hydrochloride - Generic Drug Details

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

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 seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alogliptin benzoate; metformin hydrochloride has one hundred and five patent family members in thirty-seven countries.

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

US Patents and Regulatory Information for alogliptin benzoate; metformin hydrochloride

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;ORAL 203414-001 Jan 25, 2013 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;ORAL 203414-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,157,429 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
7,829,530 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/012 Ireland ➤ Sign Up PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
2014 00011 Denmark ➤ Sign Up PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130923
90014-6 Sweden ➤ Sign Up PRODUCT NAME: ALOGLIPTIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; REG. NO/DATE: EU/1/13/844 20130919
2 5006-2014 Slovakia ➤ Sign Up PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130919
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Express Scripts
QuintilesIMS
McKinsey
Citi
AstraZeneca
Deloitte
US Department of Justice

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.