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Last Updated: March 19, 2024

Alogliptin benzoate; metformin hydrochloride - Generic Drug Details


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What are the generic drug sources for alogliptin benzoate; metformin hydrochloride and what is the scope of 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 four 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 ninety patent family members in forty-one countries.

Three suppliers are listed for this compound.

Summary for alogliptin benzoate; metformin hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for alogliptin benzoate; metformin hydrochloride
Generic Entry Date for alogliptin benzoate; metformin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for alogliptin benzoate; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Celltrion Pharm, Inc.Phase 4
TakedaPhase 4
Seoul National University HospitalPhase 4

See all alogliptin benzoate; metformin hydrochloride clinical trials

Pharmacology for alogliptin benzoate; metformin hydrochloride
Paragraph IV (Patent) Challenges for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KAZANO Tablets alogliptin benzoate; metformin hydrochloride 12.5 mg/500 mg and 12.5 mg/1000 mg 203414 3 2017-01-25

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

Expired US Patents for alogliptin benzoate; metformin hydrochloride

International Patents for alogliptin benzoate; metformin hydrochloride

Country Patent Number Title Estimated Expiration
New Zealand 549716 Pyrimidin-dione derivatives as dipeptidyl peptidase inhibitors ⤷  Try a Trial
Japan 2010533643 ⤷  Try a Trial
Taiwan 200914066 Solid preparation ⤷  Try a Trial
Hungary S1400007 ⤷  Try a Trial
Japan 4948298 ⤷  Try a Trial
Canada 2559302 INHIBITEURS DE LA DIPEPTIDYLE PEPTIDASE (DIPEPTIDYL PEPTIDASE INHIBITORS) ⤷  Try a Trial
Tunisia 2010000019 SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 PA2014045 Lithuania ⤷  Try a Trial PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 CA 2014 00066 Denmark ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
1586571 2014C/010 Belgium ⤷  Try a Trial PRODUCT NAME: ALOGLIPTINE (EN TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/13/844/001 20130923
1084705 C300709 Netherlands ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 C01084705/05 Switzerland ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1586571 SPC/GB14/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/844/001-027 20130923
1586571 CA 2014 00011 Denmark ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN; REG. NO/DATE: EU/1/13/844/001-027 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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