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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Argus Health
Express Scripts
Colorcon
Deloitte
McKesson
Accenture
AstraZeneca
Healthtrust
US Department of Justice

Generated: January 19, 2018

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 fifteen 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 alogliptin benzoate
Pharmacology for alogliptin benzoate

US Patents and Regulatory Information for 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;ORAL 022426-005 Jan 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-004 Jan 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Takeda Pharms Usa OSENI alogliptin benzoate; pioglitazone hydrochloride TABLET;ORAL 022426-003 Jan 25, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-002 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-003 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Takeda Pharms Usa NESINA alogliptin benzoate TABLET;ORAL 022271-001 Jan 25, 2013 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,911,459 Pharmaceutical composition ➤ Subscribe
5,965,584 Pharmaceutical composition ➤ Subscribe
7,842,706 Pharmaceutical composition ➤ Subscribe
8,329,900 Dipeptidyl peptidase inhibitors ➤ Subscribe
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
7,781,584 Dipeptidyl peptidase inhibitors ➤ Subscribe
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Subscribe
6,172,090 Pharmaceutical composition ➤ Subscribe
6,232,330 Pharmaceutical composition ➤ Subscribe
6,225,326 Pharmaceutical composition ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for alogliptin benzoate

Supplementary Protection Certificates for alogliptin benzoate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00064 Denmark ➤ Subscribe PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
0280 Netherlands ➤ Subscribe 300280, 20170424, EXPIRES: 20220320
2014 00064 Denmark ➤ Subscribe PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
0308 Netherlands ➤ Subscribe 300308, 20170424, EXPIRES: 20220423
2014041 Lithuania ➤ Subscribe PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1174135/01 Switzerland ➤ Subscribe FORMER REPRESENTATIVE: BOHEST AG, CH
C0006 France ➤ Subscribe PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1084705/01 Switzerland ➤ Subscribe PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
0258 Netherlands ➤ Subscribe 300258, 20160620, EXPIRES: 20210619
C/GB07/009 United Kingdom ➤ Subscribe SPC/GB07/009: 20070126
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Boehringer Ingelheim
Farmers Insurance
Queensland Health
Express Scripts
Harvard Business School
Chinese Patent Office
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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