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Last Updated: August 10, 2020

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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-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
All India Institute of Medical Sciences, BhubaneswarPhase 4
Azienda Ospedaliero-Universitaria di ParmaPhase 2/Phase 3
Chang Gung Memorial HospitalPhase 2

See all metformin hydrochloride; pioglitazone hydrochloride clinical trials

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
Teva Pharms Usa PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091155-002 Mar 10, 2014 AB RX No No   Start Trial   Start Trial   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
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
Mylan PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 090406-001 Feb 25, 2011 DISCN 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
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
>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
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
1506211 300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211 C300677 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1412357 C300357 Netherlands   Start Trial PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
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
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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