.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Johnson and Johnson
Covington
Chubb
US Army
Merck
McKinsey
Federal Trade Commission
Fish and Richardson

Generated: November 24, 2017

DrugPatentWatch Database Preview

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for metformin hydrochloride; pioglitazone hydrochloride and what is the scope of metformin hydrochloride; pioglitazone hydrochloride freedom to operate?

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 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 Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Aurobindo Pharma Ltd
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL200823-001Feb 13, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
Macleods Pharms Ltd
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL204802-001Nov 5, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXYesNo► Subscribe► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-002Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 2005► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: metformin hydrochloride; pioglitazone hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2008100240► Subscribe
China101675929► Subscribe
South Korea20130039344► Subscribe
Canada2564750► Subscribe
Argentina054238► Subscribe
Slovenia1561472► Subscribe
European Patent Office1335708► Subscribe
China1852703► Subscribe
Israel186308► Subscribe
South Korea20060076299► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2008000046Germany► SubscribePRODUCT 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
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
128Luxembourg► SubscribePRODUCT 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
2013 00001Denmark► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
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
/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
496Luxembourg► SubscribePRODUCT 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
Teva
McKinsey
Cipla
Dow
Cerilliant
Boehringer Ingelheim
Federal Trade Commission
Novartis
Daiichi Sankyo

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot