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Last Updated: September 21, 2021

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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 eighty-eight patent family members in forty countries.

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

Recent Clinical Trials for alogliptin benzoate; metformin hydrochloride

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

SponsorPhase
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 NDA Submissiondate
KAZANO TABLET;ORAL alogliptin benzoate; metformin hydrochloride 203414 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 203414-002 Jan 25, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-002 Jan 25, 2013 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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

Supplementary Protection Certificates for alogliptin benzoate; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1586571 PA2014011,C1586571 Lithuania ⤷  Try it Free PRODUCT NAME: ALOGLIPTINAS; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571 14C0013 France ⤷  Try it Free PRODUCT NAME: ALOGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/844 20130919
1586571 SPC/GB14/012 United Kingdom ⤷  Try it Free PRODUCT NAME: ALOGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/844/001-027 20130923
1084705 SPC/GB14/083 United Kingdom ⤷  Try it Free PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1084705 C01084705/05 Switzerland ⤷  Try it Free PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1084705 CA 2014 00066 Denmark ⤷  Try it Free PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; 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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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Mallinckrodt
Boehringer Ingelheim
Colorcon
AstraZeneca

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