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Last Updated: March 19, 2024

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, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Laurus, 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, Rk Pharma, 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, Zydus Lifesciences, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Glenmark Generics, Granules India, Harman Finochem, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, and Dr Reddys Labs Sa. and is included in one hundred NDAs.

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

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

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SponsorPhase
University of MinnesotaPhase 2
George Medicines PTY LimitedPhase 2
The George InstitutePhase 2

See all METFORMIN HYDROCHLORIDE clinical trials

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
Alkem METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 091184-001 Nov 1, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intellipharmaceutics METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 202306-002 Feb 23, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Pharms Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212969-002 Nov 25, 2019 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 075976-003 Jan 24, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Laurus METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 209882-003 Aug 27, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077124-001 Dec 21, 2005 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.