Metformin hydrochloride - Generic Drug Details

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What are the generic sources for metformin hydrochloride and what is the scope of freedom to operate?

Metformin hydrochloride is the generic ingredient in seventeen branded drugs marketed by Sun Pharm, Saptalis Pharms, Ranbaxy, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, 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 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, Zydus Pharms Usa, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in one hundred and six NDAs. There are twenty-three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has one hundred and eighteen patent family members in twenty-eight countries.

There are forty-nine drug master file entries for metformin hydrochloride. Eighty-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for metformin hydrochloride

International Patents:	118
US Patents:	23
Tradenames:	17
Applicants:	69
NDAs:	106
Drug Master File Entries:	49
Suppliers / Packagers:	85
Bulk Api Vendors:	131
Clinical Trials:	2,190
Patent Applications:	38
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride
DailyMed Link:	metformin hydrochloride at DailyMed

Recent Clinical Trials for metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor College of Medicine	Phase 3
US Department of Veterans Affairs	Phase 3
Mansoura University	Phase 2/Phase 3

See all metformin hydrochloride clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	500MG	TABLET, EXTENDED RELEASE;ORAL
Start Trial	Start Trial	1GM; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
Start Trial	Start Trial	500MG; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for metformin hydrochloride

Drug Class	Biguanide

Medical Subject Heading (MeSH) Categories for metformin hydrochloride

Hypoglycemic Agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ivax Sub Teva Pharms	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075975-002	Jan 24, 2002		DISCN	No	No	Start Trial	Start Trial				Start Trial
Barr	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076496-001	Nov 25, 2005		DISCN	No	No	Start Trial	Start Trial				Start Trial
Granules India	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	090564-003	Apr 22, 2010	AB	RX	No	Yes	Start Trial	Start Trial				Start Trial
Ipca Labs Ltd	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	078422-002	Aug 6, 2007		DISCN	No	No	Start Trial	Start Trial				Start Trial
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for metformin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	Start Trial	Start Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	Start Trial	Start Trial
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	Start Trial	Start Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	Start Trial	Start Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for metformin hydrochloride

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Country	Patent Number	Estimated Expiration
European Patent Office	2260832	Start Trial
Norway	20043913	Start Trial
Australia	2001239893	Start Trial
Canada	2412671	Start Trial
Australia	2018250470	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for metformin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C01506211/02	Switzerland	Start Trial	PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	CA 2008 00035	Denmark	Start Trial	PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357	PA2008013,C1412357	Lithuania	Start Trial	PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1261586	12C0028	France	Start Trial	PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1506211	CR 2014 00037	Denmark	Start Trial	PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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