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Serving leading biopharmaceutical companies globally:

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Cantor Fitzgerald
Baxter
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Generated: December 14, 2017

DrugPatentWatch Database Preview

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.

Metformin hydrochloride; pioglitazone hydrochloride has one hundred and forty-four patent family members in thirty-two countries and thirty supplementary protection certificates in eleven countries.

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

Summary for metformin hydrochloride; pioglitazone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
SandozPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL091273-001Apr 16, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
MylanPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL090406-002Feb 25, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
SandozPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL091273-002Apr 16, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► 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 UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS METmetformin hydrochloride; pioglitazone hydrochlorideTABLET;ORAL021842-002Aug 29, 2005► Subscribe► 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
8,084,058Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative► Subscribe
8,309,125Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative► 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
Argentina054238► Subscribe
Japan2013209426► Subscribe
World Intellectual Property Organization (WIPO)2006044077► Subscribe
Australia2003272504► Subscribe
Denmark1561472► Subscribe
Japan2002506810► Subscribe
Singapore160415► Subscribe
Japan2008208141► Subscribe
Japan5827781► Subscribe
Japan2010159290► 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
00677Netherlands► SubscribePRODUCT 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
2014000071Germany► 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
9 5017-2014Slovakia► SubscribePRODUCT 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
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0028France► SubscribePRODUCT 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
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
5006-2008Slovakia► SubscribePRODUCT 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
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
/2012Austria► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Federal Trade Commission
Colorcon
Novartis
QuintilesIMS
Accenture
Baxter
Daiichi Sankyo
Queensland Health

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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