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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Cerilliant
Moodys
McKesson
Novartis
Daiichi Sankyo
Johnson and Johnson
Express Scripts
Cipla
Fish and Richardson

Generated: September 22, 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-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-three patent family members in thirty-three countries.

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

Summary for Generic Name: METFORMIN HYDROCHLORIDE

Tradenames:16
Patents:36
Applicants:53
NDAs:91
Drug Master File Entries: see list48
Suppliers / Packagers: see list94
Bulk Api Vendors: see list82
Clinical Trials: see list3,979
Patent Applications: see list32
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
Indicus Pharma
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL079148-003Nov 25, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL076223-001Dec 14, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL076706-002Dec 29, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sciegen Pharms Inc
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL203769-002Sep 11, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYesYes► Subscribe► Subscribe ► Subscribe
Amneal Pharms Ny
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL077880-001Jun 5, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL076328-001Dec 16, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Takeda Pharms Usa
ACTOPLUS MET
metformin hydrochloride; pioglitazone hydrochloride
TABLET;ORAL021842-001Aug 29, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► 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, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 2005► Subscribe► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005► Subscribe► 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
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
6,559,187 Liquid formulation of metformin► 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
Canada2290624► Subscribe
China1308520► Subscribe
New Zealand535456► Subscribe
World Intellectual Property Organization (WIPO)03072025► Subscribe
Israel154307► Subscribe
Australia2003211145► Subscribe
Australia2001239893► Subscribe
Austria302597► Subscribe
Japan2013237689► Subscribe
Iceland6709► 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
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
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
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:
0677Netherlands► 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
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
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
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
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Merck
Fuji
Deloitte
AstraZeneca
Johnson and Johnson
Medtronic
McKinsey
Moodys
QuintilesIMS
UBS

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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