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Metformin hydrochloride - Generic Drug Details

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Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed by Bristol Myers Squibb, Apotex, 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 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.

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:36
Applicants:53
NDAs:90
Drug Master File Entries: see list47
Suppliers / Packagers: see list92
Bulk Api Vendors: see list82
Clinical Trials: see list1,688
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
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL500MG; EQ 50MG BASE
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL1GM; EQ 50MG BASE
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL1GM; EQ 100MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075973-001Jan 25, 2002RXNo► subscribe► subscribe
Beximco Pharms Usa
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL207427-001Dec 13, 2016RXNo► subscribe► subscribe
Takeda Pharms Usa
ACTOPLUS MET XR
metformin hydrochloride; pioglitazone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022024-001May 12, 2009RXNo6,495,162► 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;ORAL021748-002Jun 3, 20056,340,475► 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
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
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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
Australia2003211145► subscribe
World Intellectual Property Organization (WIPO)9947128► subscribe
Germany69941115► 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
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
77; 5006-2008Slovakia► subscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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
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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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