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Last Updated: August 9, 2020

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Metformin hydrochloride - Generic Drug Details

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What are the generic sources for metformin hydrochloride and what is the scope of freedom to operate?

Metformin hydrochloride is the generic ingredient in seventeen branded drugs marketed by Sun Pharm, Saptalis Pharms, Ranbaxy, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cadila, Cspc Ouyi, Glenmark Pharms Ltd, Granules India Ltd, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Watson Labs Inc, Yichang Humanwell, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Laurus Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Sunshine Lake, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in one hundred and six NDAs. There are twenty-three 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 eighteen patent family members in twenty-eight countries.

There are forty-nine drug master file entries for metformin hydrochloride. Eighty-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baylor College of MedicinePhase 3
US Department of Veterans AffairsPhase 3
Mansoura UniversityPhase 2/Phase 3

See all metformin hydrochloride clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GM; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial500MG; EQ 50MG BASETABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for metformin hydrochloride
Drug ClassBiguanide
Medical Subject Heading (MeSH) Categories for metformin hydrochloride
Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
RIOMET SOLUTION;ORAL metformin hydrochloride 021591 2018-02-02
GLUMETZA TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021748 2009-07-27
FORTAMET TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021574 2008-10-14
GLUCOPHAGE XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021202

US Patents and Regulatory Information for metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 075975-002 Jan 24, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Barr METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076496-001 Nov 25, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Granules India METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 090564-003 Apr 22, 2010 AB RX No Yes   Start Trial   Start Trial   Start Trial
Ipca Labs Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 078422-002 Aug 6, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004   Start Trial   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005   Start Trial   Start Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004   Start Trial   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005   Start Trial   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C01506211/02 Switzerland   Start Trial PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357 CA 2008 00035 Denmark   Start Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1261586 12C0028 France   Start Trial PRODUCT 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 CR 2014 00037 Denmark   Start Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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