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Serving hundreds of leading biopharmaceutical companies globally:

Citi
QuintilesIMS
Chubb
Daiichi Sankyo
UBS
Express Scripts
Cipla
Medtronic
Moodys

Generated: September 24, 2018

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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 metformin hydrochloride; pioglitazone hydrochloride 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 thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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
Sandoz PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091273-002 Apr 16, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Macleods Pharms Ltd PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 204802-001 Nov 5, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 090406-001 Feb 25, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 090406-002 Feb 25, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-002 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012022 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1506211/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
77; 5006-2008 Slovakia ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2014000071 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2014026 Lithuania ➤ Try a Free Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2008 00035 Denmark ➤ Try a Free Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
QuintilesIMS
Chubb
Daiichi Sankyo
UBS
Express Scripts
Cipla
Medtronic
Moodys

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