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Last Updated: April 1, 2023

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, 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, Cadila, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, 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, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Watson Labs Inc, Yichang Humanwell, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma, Glenmark Generics, Granules India, Harman Finochem, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Laurus, Provident Pharm, Sun Pharm Inds Inc, Sunshine, 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 eighteen NDAs. There are eighteen 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-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
University of MinnesotaPhase 2
Hangzhou Sciwind Biosciences Co., Ltd.Phase 3
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.Phase 1

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
Anatomical Therapeutic Chemical (ATC) Classes 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
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Hlthcare METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 203686-002 Aug 28, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076985-001 Sep 13, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212969-001 Nov 25, 2019 AB3 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206955-002 Dec 7, 2016 AB RX 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
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Ranbaxy RIOMET metformin hydrochloride SOLUTION;ORAL 021591-001 Sep 11, 2003 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ⤷  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
European Patent Office 3445349 ⤷  Sign Up
Australia 2003211146 CONTROLLED RELEASE DOSAGE FORMS ⤷  Sign Up
Canada 2476496 FORMES POSOLOGIQUES A LIBERATION CONTROLEE (CONTROLLED RELEASE DOSAGE FORMS) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016178132 ⤷  Sign Up
Japan 2017514903 徐放性懸濁組成物 ⤷  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 CR 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
1506211 SPC/GB14/050 United Kingdom ⤷  Sign Up PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1412357 PA2008013,C1412357 Lithuania ⤷  Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1506211 PA2014026 Lithuania ⤷  Sign Up PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1412357 DO 77; 5006-2008 Slovakia ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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