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Metformin hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for metformin hydrochloride?

Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed by Bristol Myers Squibb, Apotex, Intellipharmaceutics, Ranbaxy Labs Ltd, Torrent Pharms, Mylan, Torrent Pharm, Sun Pharma Global, Aurobindo Pharma Ltd, Watson Labs Inc, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Sandoz, Sun Pharm Inds, Torrent Pharms Ltd, 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-two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and thirty patent family members in thirty-three countries.

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

Summary for Generic Name: metformin hydrochloride

Tradenames:16
Patents:33
Applicants:54
NDAs:91
Drug Master File Entries: see list47
Suppliers / Packagers: see list92
Bulk Api Vendors: see list82
Clinical Trials: see list1,693
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. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL500MG; EQ 50MG BASE
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL1GM; EQ 50MG BASE
► Subscribe► SubscribeTABLET, EXTENDED RELEASE;ORAL1GM; EQ 100MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds (in)
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077336-001Feb 9, 2006RXNoNo► Subscribe► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004RXYesNo6,495,162► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYesYes7,125,873► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-005Aug 25, 2003DISCNYesNo8,236,345► SubscribeY ► Subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-002May 12, 2009RXYesYes9,060,941► SubscribeY ► 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;ORAL021748-001Jun 3, 20056,340,475► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 20056,635,280► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,635,280► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-002Jun 3, 20056,340,475► 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
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
2,005,182,056► 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
Slovenia1476138► Subscribe
Hungary0302700► Subscribe
African Intellectual Property Organization (OAPI)11484► Subscribe
Portugal1294363► Subscribe
European Patent Office2332522► 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
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. 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
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:
/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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