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Last Updated: June 4, 2023

METFORMIN HYDROCHLORIDE Drug Patent Profile


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When do Metformin Hydrochloride patents expire, and when can generic versions of Metformin Hydrochloride launch?

Metformin Hydrochloride is a drug marketed by Saptalis Pharms, Vistapharm, 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, 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, and Zydus Pharms Usa. and is included in ninety-seven NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Metformin Hydrochloride

A generic version of METFORMIN HYDROCHLORIDE was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.

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Drug patent expirations by year for METFORMIN HYDROCHLORIDE
Recent Clinical Trials for METFORMIN HYDROCHLORIDE

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SponsorPhase
University of MinnesotaPhase 2
The George InstitutePhase 2
MRCF Pty LtdPhase 2

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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
Ranbaxy Labs Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076413-001 Jun 18, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Ny METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 077880-002 Jun 5, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Impax Labs METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076985-001 Sep 13, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cspc Ouyi METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 078321-001 Apr 17, 2008 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 075976-002 Jan 24, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 205330-001 Oct 31, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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