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Last Updated: August 12, 2020

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METFORMIN HYDROCHLORIDE Drug 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, 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, 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, and Zydus Pharms Usa. and is included in eighty-five NDAs.

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

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

See all METFORMIN HYDROCHLORIDE clinical trials

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
Watson Labs Inc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 076818-001 Dec 14, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 205096-003 Jul 11, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 206955-001 Dec 7, 2016 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
Teva METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 076328-002 Dec 16, 2002 DISCN 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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