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Serving 500+ biopharmaceutical companies globally:

Queensland Health
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Metformin hydrochloride - Generic Drug Details

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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 Bristol Myers Squibb, Apotex, Intellipharmaceutics, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharms Ltd, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, Beximco Pharms Usa, Teva, Atlas Pharms Llc, Sun Pharm Inds (in), Ivax Sub Teva Pharms, Santarus Inc, Indicus Pharma, Impax Labs, Actavis Elizabeth, Provident Pharm, Actavis Labs Fl Inc, Macleods Pharms Ltd, Nostrum Pharms Llc, Zydus Pharms Usa, Watson Labs Florida, Barr, Lupin Ltd, Granules India, Sun Pharm Inds Inc, Mylan Pharms Inc, Sciegen Pharms Inc, Glenmark Generics, Chartwell Life Sci, Andrx Labs Llc, Watson Labs, Amneal Pharms Ny, Alkem, Zydus Hlthcare, Dr Reddys Labs Inc, Marksans Pharma, Sun Pharm Inds Ltd, Inventia Hlthcare, Aurobindo, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in ninety-one NDAs. There are thirty-seven 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-one patent family members in thirty-three countries.

There are forty-seven drug master file entries for metformin hydrochloride. Ninety-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: metformin hydrochloride

Tradenames:16
Patents:37
Applicants:53
NDAs:91
Drug Master File Entries: see list47
Suppliers / Packagers: see list93
Bulk Api Vendors: see list82
Clinical Trials: see list3,918
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:metformin hydrochloride at DailyMed

Pharmacology for Ingredient: metformin hydrochloride

Ingredient-typeBiguanides
Drug ClassBiguanide

Tentative approvals for METFORMIN HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe500MGTABLET, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
► Subscribe► 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
Sandoz
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075985-001Jan 25, 2002ABRXNoNo► Subscribe► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo► Subscribe► Subscribe
Apotex
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075984-003Apr 23, 2002ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL091664-001Jul 19, 2013AB3RXNoNo► Subscribe► Subscribe
Amneal Pharms Ny
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL078596-001Jan 3, 2008AB1RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,635,280► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,635,280► Subscribe
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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
2,005,182,056► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
6,559,187 Liquid formulation of metformin► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► 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

Country Document Number Estimated Expiration
Canada2409999► Subscribe
Japan2005526043► Subscribe
Spain2213108► Subscribe
Japan2000513028► Subscribe
European Patent Office1446106► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
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
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
C0006France► SubscribePRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
AstraZeneca
UBS
Fuji
US Army
US Department of Justice
Novartis
Moodys
Fish and Richardson
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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