METFORMIN HYDROCHLORIDE - Generic Drug Details

✉ Email this page to a colleague

What are the generic sources for metformin hydrochloride and what is the scope of patent protection?

Metformin hydrochloride is the generic ingredient in twenty branded drugs marketed by Sun Pharm, Saptalis Pharms, Vistapharm, 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, 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 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, 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, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, and Msd Sub Merck, and is included in one hundred and twenty-five NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has fifty-five patent family members in sixteen countries.

There are forty-three 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:	55
US Patents:	10
Tradenames:	20
Applicants:	78
NDAs:	125
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	85
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2,543
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
State University of New York - Downstate Medical Center	Phase 1/Phase 2
University of Arkansas	Phase 1
Alexion Pharmaceuticals, Inc.	Phase 1

See all METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	500MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	500MG; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	1GM; EQ 100MG 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

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075967-003	Jan 29, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206955-002	Dec 7, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; repaglinide	TABLET;ORAL	200624-002	Jul 15, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cspc Ouyi	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	205096-003	Jul 11, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-002	May 12, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mylan	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205981-002	Jul 31, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	090406-002	Feb 25, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for METFORMIN HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Mexico	2016014320	COMPOSICIONES DE SUSPENSION DE LIBERACION PROLONGADA. (EXTENDED RELEASE SUSPENSION COMPOSITIONS.)	⤷ Sign Up
Cyprus	1112517		⤷ Sign Up
European Patent Office	3445349		⤷ Sign Up
Denmark	1476138		⤷ Sign Up
Japan	2010155864	MODIFIED RELEASE PHARMACEUTICAL COMPOSITION OF AT LEAST ONE FORM OF TRAMADOL	⤷ Sign Up
Japan	4704685		⤷ Sign Up
Australia	2017254908		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania	⤷ Sign Up	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	92128	Luxembourg	⤷ Sign Up	PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
1506211	C 2014 029	Romania	⤷ Sign Up	PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211	92496	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1261586	15/2012	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1261586	C01261586/02	Switzerland	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
2498758	301040	Netherlands	⤷ Sign Up	PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.