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Last Updated: May 23, 2024

METFORMIN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for metformin hydrochloride and what is the scope of patent protection?

Metformin hydrochloride is the generic ingredient in twenty branded drugs marketed by Sun Pharm, Saptalis Pharms, Vistapharm, 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, Amta, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Harman Finochem, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, and Msd Sub Merck, and is included in one hundred and twenty-five NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has fifty-five patent family members in sixteen countries.

There are forty-three drug master file entries for metformin hydrochloride. Eighty-six 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
University of MinnesotaPhase 2
George Medicines PTY LimitedPhase 2
The George InstitutePhase 2

See all METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up500MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up1GM; 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 Strength NDA ANDAs Submitted Submissiondate
RIOMET Oral Solution metformin hydrochloride 500 mg/5 mL 021591 1 2018-02-02
GLUMETZA Extended-release Tablets metformin hydrochloride 500 mg and 1000 mg 021748 1 2009-07-27
FORTAMET Extended-release Tablets metformin hydrochloride 500 mg and 1000 mg 021574 1 2008-10-14

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
Marksans Pharma METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 090888-001 Mar 12, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Twi Pharms METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 213247-002 Sep 29, 2021 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 077064-002 Apr 18, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 203769-003 Sep 11, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206081-003 Jul 31, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs Inc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076818-001 Dec 14, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Ranbaxy RIOMET metformin hydrochloride SOLUTION;ORAL 021591-001 Sep 11, 2003 ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ⤷  Sign Up ⤷  Sign Up
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for METFORMIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Japan 2005526043 ⤷  Sign Up
Japan 2010155864 MODIFIED RELEASE PHARMACEUTICAL COMPOSITION OF AT LEAST ONE FORM OF TRAMADOL ⤷  Sign Up
European Patent Office 3288549 ⤷  Sign Up
Canada 2476496 FORMES POSOLOGIQUES A LIBERATION CONTROLEE (CONTROLLED RELEASE DOSAGE FORMS) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016178131 ⤷  Sign Up
Canada 2947528 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 2090013-0 Sweden ⤷  Sign Up PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1261586 12C0028 France ⤷  Sign Up 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
1261586 15/2012 Austria ⤷  Sign Up PRODUCT 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
1412357 DO 77; 5006-2008 Slovakia ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2498758 CA 2020 00017 Denmark ⤷  Sign Up PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1412357 SPC/GB08/040 United Kingdom ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.