METFORMIN HYDROCHLORIDE Drug Patent Profile

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 24^th, 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

See all METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for METFORMIN HYDROCHLORIDE

Drug Class

Biguanide

Medical Subject Heading (MeSH) Categories for METFORMIN HYDROCHLORIDE

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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