.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Deloitte
Cantor Fitzgerald
Julphar
Accenture
Mallinckrodt
Citi
Cerilliant
Novartis
Queensland Health
AstraZeneca

Generated: December 18, 2017

DrugPatentWatch Database Preview

Metformin hydrochloride - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for metformin hydrochloride and what is the scope of metformin hydrochloride patent protection?

Metformin hydrochloride
is the generic ingredient in sixteen branded drugs marketed by Sun Pharm Inds Ltd, Andrx Labs Llc, Bristol Myers Squibb, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi Pharm Co, Impax Labs, Intellipharmaceutics, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in ninety-two NDAs. There are thirty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has one hundred and thirty-six patent family members in thirty-three countries and thirty supplementary protection certificates in eleven countries.

There are forty-eight drug master file entries for metformin hydrochloride. One hundred suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for metformin hydrochloride

Ingredient-typeBiguanides
Drug ClassBiguanide

Medical Subject Heading (MeSH) Categories for metformin hydrochloride

Tentative approvals for METFORMIN HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe500MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
u► Subscribe1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cspc Ouyi Pharm CoMETFORMIN HYDROCHLORIDEmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL078321-001Apr 17, 2008AB1RXNoNo► Subscribe► Subscribe► Subscribe
Granules IndiaMETFORMIN HYDROCHLORIDEmetformin hydrochlorideTABLET;ORAL090564-003Apr 22, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdMETFORMIN HYDROCHLORIDEmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL079118-002Jul 20, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Ipca Labs LtdMETFORMIN HYDROCHLORIDEmetformin hydrochlorideTABLET;ORAL078422-003Aug 6, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaACTOPLUS MET XRmetformin hydrochloride; pioglitazone hydrochlorideTABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
Sciegen Pharms IncMETFORMIN HYDROCHLORIDEmetformin hydrochlorideTABLET;ORAL203769-003Sep 11, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Astrazeneca AbKOMBIGLYZE XRmetformin hydrochloride; saxagliptin hydrochlorideTABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005AB3RXYesYes► 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus IncGLUMETZAmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 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

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
6,559,187 Liquid formulation of metformin► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
2,005,182,056► 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

Country Document Number Estimated Expiration
Portugal998271► Subscribe
Spain2248908► Subscribe
European Patent Office2260832► Subscribe
World Intellectual Property Organization (WIPO)2010064126► Subscribe
Japan2010159290► Subscribe
Japan4557424► Subscribe
Japan2002506812► Subscribe
Austria536863► Subscribe
Iceland6709► Subscribe
Germany69831335► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
1506211/02Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
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
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
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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
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 plans and pricing

Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Fuji
Covington
Cerilliant
Cipla
Moodys
US Army
UBS
QuintilesIMS

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:

botpot