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Last Updated: December 6, 2019

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Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of freedom to operate?

Metformin hydrochloride; pioglitazone hydrochloride is the generic ingredient in three branded drugs marketed by Takeda Pharms Usa, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan, Sandoz, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; pioglitazone hydrochloride has one hundred and twenty-eight patent family members in thirty-one countries.

There are forty-nine drug master file entries for metformin hydrochloride; pioglitazone hydrochloride. Six suppliers are listed for this compound.

Recent Clinical Trials for metformin hydrochloride; pioglitazone hydrochloride

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

SponsorPhase
Khyber Medical University PeshawarPhase 4
Wayne State UniversityPhase 2/Phase 3
Hamad Medical CorporationPhase 3

See all metformin hydrochloride; pioglitazone hydrochloride clinical trials

Recent Litigation for metformin hydrochloride; pioglitazone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Shionogi Inc. v. Amneal Pharmaceuticals, LLC2018-10-11
SHIONOGI INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2018-08-16
Shionogi Inc. v. Qingdao Baheal Pharmaceutical Co. Ltd.2017-09-22

See all metformin hydrochloride; pioglitazone hydrochloride litigation

PTAB Litigation
PetitionerDate
Aurobindo Pharma USA Inc.2018-01-24
Aurobindo Pharma USA Inc.2017-06-23
Aurobindo Pharma USA Inc.2017-06-22

See all metformin hydrochloride; pioglitazone hydrochloride litigation

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ACTOPLUS MET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; pioglitazone hydrochloride 022024 2011-09-23

US Patents and Regulatory Information for metformin hydrochloride; pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 200823-001 Feb 13, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Macleods Pharms Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 204802-001 Nov 5, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent Pharms Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 202001-001 Feb 13, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 090406-002 Feb 25, 2011 DISCN No No   Start Trial   Start Trial   Start 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 metformin hydrochloride; pioglitazone hydrochloride

Supplementary Protection Certificates for metformin hydrochloride; pioglitazone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 179 5017-2014 Slovakia   Start Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1506211 92496 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211 C 2014 029 Romania   Start Trial PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1261586 12C0028 France   Start Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1412357 122008000046 Germany   Start Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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