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Last Updated: January 25, 2020

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Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details

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What are the generic sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of patent protection?

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-seven 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
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-002 Aug 29, 2005   Start Trial   Start Trial
Takeda Pharms Usa ACTOPLUS MET metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 021842-001 Aug 29, 2005   Start Trial   Start Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for metformin hydrochloride; pioglitazone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1412357 77 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
1532149 92128 Luxembourg   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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