Last Updated: May 6, 2026

METFORMIN Drug Patent Profile


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When do Metformin patents expire, and what generic alternatives are available?

Metformin is a drug marketed by Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, Micro Labs, Mpp Pharma, Mylan Pharms Inc, Nostrum Pharms Llc, Novast Labs, Pharmobedient, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Regcon Holdings, Rk Pharma, Sandoz, Sciegen Pharms, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Aarxion Anda Hlding, Alkem, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Senores Pharms, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, and Zydus Pharms Usa. and is included in one hundred and four NDAs.

The generic ingredient in METFORMIN is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Metformin

A generic version of METFORMIN was approved as metformin hydrochloride by CHARTWELL on January 24th, 2002.

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Summary for METFORMIN

US Patents and Regulatory Information for METFORMIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prinston Inc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208880-002 Sep 10, 2018 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Utopic Pharms METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 213394-001 Aug 3, 2021 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Impax Labs METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076985-001 Sep 13, 2005 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glenmark Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212969-002 Nov 25, 2019 AB3 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Marksans Pharma METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 090888-003 Mar 12, 2012 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ipca Labs Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 078422-001 Aug 6, 2007 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 214629-001 Feb 22, 2022 AB2 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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