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.
Summary for METFORMIN HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 66 |
NDAs: | 97 |
Finished Product Suppliers / Packagers: | 83 |
Raw Ingredient (Bulk) Api Vendors: | 160 |
Clinical Trials: | 2,511 |
Patent Applications: | 897 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METFORMIN HYDROCHLORIDE |
What excipients (inactive ingredients) are in METFORMIN HYDROCHLORIDE? | METFORMIN HYDROCHLORIDE excipients list |
DailyMed Link: | METFORMIN HYDROCHLORIDE at DailyMed |

Recent Clinical Trials for METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Minnesota | Phase 2 |
The George Institute | Phase 2 |
MRCF Pty Ltd | Phase 2 |
Pharmacology for METFORMIN HYDROCHLORIDE
Drug Class | Biguanide |
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 |