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Metformin hydrochloride; pioglitazone hydrochloride - Generic Drug Details

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

This ingredient has two hundred and six patent family members in thirty-eight countries.

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

Summary for Generic Name: metformin hydrochloride; pioglitazone hydrochloride

Tradenames:3
Patents:17
Applicants:7
NDAs:8
Drug Master File Entries: see list47
Suppliers / Packaging: see list12
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYes6,166,042► subscribe ► subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYes7,785,627► subscribeY ► subscribe
Mylan
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL090406-002Feb 25, 2011RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: 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;ORAL022024-002May 12, 20096,166,043► subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 20096,166,042► subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 20056,172,090► subscribe
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Non-Orange Book Patents for Generic Ingredient: metformin hydrochloride; pioglitazone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,156,773 Pharmaceutical composition► subscribe
6,211,207 Pharmaceutical composition► subscribe
6,169,100 Pharmaceutical composition► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: metformin hydrochloride; pioglitazone hydrochloride

Country Document Number Estimated Expiration
Japan2006502187► subscribe
World Intellectual Property Organization (WIPO)2005107750► subscribe
European Patent Office1723948► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000070Germany► subscribePRODUCT 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
1261586/02Switzerland► subscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
C/GB07/009United Kingdom► subscribeSPC/GB07/009: 20070126
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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