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Last Updated: November 4, 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 freedom to operate?

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
TakedaPhase 4
Celltrion Pharm, Inc.Phase 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 ⤷  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
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 ⤷  Sign Up
Takeda Pharms Usa KAZANO alogliptin benzoate; metformin hydrochloride TABLET;ORAL 203414-001 Jan 25, 2013 RX Yes No ⤷  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 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

Expired US Patents for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

International Patents for ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Hong Kong 1083338 Dipeptidyl peptidase inhibitors ⤷  Sign Up
Peru 20090882 PREPARACION SOLIDA QUE COMPRENDE ALOGLIPTINA Y CLORHIDRATO DE METFORMINA ⤷  Sign Up
Taiwan 201129553 Dipeptidyl peptidase inhibitors ⤷  Sign Up
Tunisia 2010000019 SOLID PREPARATION COMPRISING ALOGLIPTIN AND METFORMIN HYDROCHLORIDE ⤷  Sign Up
Norway 20064669 ⤷  Sign Up
Japan 4948298 ⤷  Sign Up
>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
1586571 C 2014 011 Romania ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN; NATIONAL AUTHORISATION NUMBER: EU/1/13/844/001 - EU/1/13/844/027; DATE OF NATIONAL AUTHORISATION: 20130919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/844/001 - EU/1/13/844/027; DATE OF FIRST AUTHORISATION IN EEA: 20130919
1586571 2014/012 Ireland ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 SPC/GB14/083 United Kingdom ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1586571 1490014-6 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20241222 - 20280922
1586571 252 5006-2014 Slovakia ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/13/844/001 - EU/1/13/844/027 20130923
1586571 C300640 Netherlands ⤷  Sign Up PRODUCT NAME: ALOGLIPTINE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/13/844/001-007 20130923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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