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Last Updated: April 26, 2024

Metformin hydrochloride - Generic Drug Details

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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, 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, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, Zydus, and Msd Sub Merck, and is included in one hundred and twenty-four 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-six 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:	80
NDAs:	124
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	86
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2,523
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
MRCF Pty Ltd	Phase 2
George Medicines PTY Limited	Phase 2

See all metformin hydrochloride clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	500MG	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	1GM; EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
⤷ Try a Trial	⤷ Try a Trial	1GM; 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	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

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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
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077113-001	Sep 8, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms Usa	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	077064-001	Apr 18, 2005	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
Marksans Pharma	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	090888-003	Mar 12, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Nostrum Pharms Llc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076756-002	Dec 12, 2011	AB	RX	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

Expired US Patents for metformin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Try a Trial	⤷ Try a Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Try a Trial	⤷ Try a Trial
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	⤷ Try a Trial	⤷ Try a Trial
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	⤷ Try a Trial	⤷ Try a Trial
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	⤷ Try a Trial	⤷ Try a Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	⤷ Try a Trial	⤷ Try a 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	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016016845		⤷ Try a Trial
European Patent Office	3174515		⤷ Try a Trial
Norway	20043913		⤷ Try a Trial
Australia	2017254908		⤷ Try a Trial
Canada	2984725		⤷ Try a Trial
Australia	2018250470		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for metformin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	PA2020003,C2498758	Lithuania	⤷ Try a Trial	PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211	300677	Netherlands	⤷ Try a Trial	PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2498758	CR 2020 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
2498758	301040	Netherlands	⤷ Try a Trial	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
2498758	2020C/509	Belgium	⤷ Try a Trial	PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
2498758	LUC00152	Luxembourg	⤷ Try a Trial	PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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