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Last Updated: November 21, 2019

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METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Metformin hydrochloride is the generic ingredient in seventeen branded drugs marketed by Sun Pharm, Sun Pharm Inds Ltd, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cadila, Cspc Ouyi, 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 three NDAs. There are twenty-six 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. Ninety-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for METFORMIN HYDROCHLORIDE

International Patents:	118
US Patents:	26
Tradenames:	17
Applicants:	66
NDAs:	103
Drug Master File Entries:	49
Suppliers / Packagers:	98
Bulk Api Vendors:	122
Clinical Trials:	2,112
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

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Sponsor	Phase
Georgetown University	Phase 2/Phase 3
Wake Forest University	Phase 2/Phase 3
National Institute on Aging (NIA)	Phase 2/Phase 3

See all METFORMIN HYDROCHLORIDE clinical trials

Recent Litigation for METFORMIN HYDROCHLORIDE

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District Court Litigation

Case Name	Date
BAUSCH HEALTH IRELAND LIMITED v. APOTEX INC.	2019-06-28
SUN PHARMACEUTICAL INDUSTRIES LTD. v. VISTAPHARM, INC.	2019-03-01
Shionogi Inc. v. Amneal Pharmaceuticals, LLC	2018-10-11

See all METFORMIN HYDROCHLORIDE litigation

PTAB Litigation

Petitioner	Date
Aurobindo Pharma USA Inc.	2018-01-24
Aurobindo Pharma USA Inc.	2017-06-23
Aurobindo Pharma USA Inc.	2017-06-22

See all METFORMIN HYDROCHLORIDE litigation

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 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
Start Trial	Start 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

Synonyms for METFORMIN HYDROCHLORIDE

(E)-2-carbamimidoyl-1,1-dimethylguanidine hydrochloride
1-dimethylbiguanide hydrochloride
1,1-Dimethylbiguanide hydrochloride
1,1-Dimethylbiguanide hydrochloride, 97%
1,1-Dimethylbiguanide monohydrochloride
1,1-Dimethylbiguanide, Hydrochloride
1115-70-4
144377-16-2
15537-72-1
3-(diaminomethylene)-1,1-dimethyl-guanidine hydrochloride
3-(diaminomethylidene)-1,1-dimethylguanidine hydrochloride
3-carbamimidoyl-1,1-dimethylguanidine;hydrochloride
56258-19-6
786Z46389E
AB0004717
AB1009370
AC-2075
AC1L23D5
ACMC-20ap7s
AI3-51264
AK163172
AKOS015894259
AN-8747
API0003318
Apo-Metformin
AX8041182
BC206669
BCP03594
Benofomin
BG0401
BIGUANIDE, 1,1-DIMETHYL-, HYDROCHLORIDE
Biguanide, 1,1-dimethyl-, monohydrochloride
Biguanide, 1,1-dimethyl-, monohydrochloride (8CI)
Biguanide,1-dimethyl-, monohydrochloride
Biocos
BP-12830
C4H11N5.HCl
C4H12ClN5
CAS-1115-70-4
CCG-208004
CHEBI:6802
CHEMBL1703
Cidophage
CS-1851
CTK8C6229
D 15095
D.B.I
D.B.I.
D00944
Dabex
DB-018697
Denkaform
Dextin
Diabefagos
Diaberit
Diabesin
Diabetex
Diabetmin
Diabetosan
Diaformin
Diamin
Diaphage
Diformin
Diformin Retard
Dimethylbiguanide hydrochloride
DMBG hydrochloride
DMGG hydrochloride
DSSTox_CID_17246
DSSTox_GSID_37246
DSSTox_RID_79314
DTXSID9037246
EC 214-230-6
EINECS 214-230-6
F2173-0894
Fornidd
Fortamet
FT-0628265
Geamet
Glibomet
Glucofago
Glucoform
Glucoliz
Glucomet
Glucomine
Gluconil
Glucophage
Glucophage (TN)
Glucophage 850
Glucophage Forte
Glucophage Retard
Glucophage XR
Glucophage-Mite
Gluformin
Glupermin
Glyciphage
Glycoran
Glyformin
GP2747
Haurymellin hydrochloride
HMS1568A09
HMS1922H14
HSDB 7080
HY-17471A
I05-0228
I14-7880
I506
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride (9CI)
Imidodicarbonimidic diamide,N-dimethyl-, monohydrochloride
Islotin retard
J10020
J10377
Jsp000870
KS-000006B5
KS-1272
KSC926E2T
LA 6023
LA 6063
LS-43900
M-2922
M2009
MCULE-9784059944
Meglucon
Meguan
Mescorit
Metbay
Metforal
Metformin (hydrochloride)
Metformin HCL
Metformin HCl ER
Metformin HCl(Glucophage)
Metformin hydrochloride (Glucophage)
Metformin hydrochloride (JP17/USP)
Metformin hydrochloride [USAN:USP:JAN]
Metformin hydrochloride [USAN]
Metformin Hydrochloride 1.0 mg/ml in Methanol (as free base)
Metformin hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Metformin hydrochloride, British Pharmacopoeia (BP) Reference Standard
Metformin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Metformin hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Metformin hydrochloride, pharmaceutical secondary standard; traceable to USP and PhEur
Metformin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Metformin Hydrochloride,(S)
Metformin monohydrochloride
Metformin, HCl
Metiguanide monohydrochloride
Metolmin
Metomin
MFCD00012582
MFCD00012582 (97+%)
MLS000028493
MLS002222221
MolPort-000-771-764
MolPort-039-227-817
N-[amino(dimethylamino)methylidene]guanidine hydrochloride
N,N-Dimethylbiguanide hydrochloride
N,N-dimethylimidodicarbonimidic diamide hydrochloride
N,N-Dimethylimidodicarbonimidic diamine
N',N'-dimethylbiguanide hydrochloride
N1,N1-Dimethylbiguanide hydrochloride
NCGC00016564-01
NCGC00016564-06
NCGC00095185-01
NCGC00095185-02
Novo-Metformin
NSC 91485
NSC-759262
NSC-91485
NSC759262
NSC91485
OETHQSJEHLVLGH-UHFFFAOYSA-N
OR322044
Pharmakon1600-01505814
Prestwick_519
Q-201360
Riomet
Risidon
RP22848
RTR-002281
s1950
SB19704
SC-17468
SCHEMBL10325580
SCHEMBL20140191
SCHEMBL22977
Siamformet
SMR000058277
SPECTRUM1505814
SR-05000001764-2
ST24048701
SY001217
Thiabet
TL8000340
Tox21_110498
Tox21_110498_1
TR-002281
TRA0069243
UNII-786Z46389E
Walaphage
Z2244578658

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
Alkem Labs Ltd	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206145-001	Oct 22, 2018	AB1	RX	No	No	Start Trial	Start Trial				Start Trial
Chartwell Life Sci	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075972-005	Jan 24, 2002		RX	No	No	Start Trial	Start Trial				Start Trial
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823-001	Feb 13, 2013	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Sandoz	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075965-001	Jan 25, 2002	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005	AB	RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Alkem	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	091184-003	Nov 1, 2010	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	Start Trial	Start Trial	Y	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
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	021748-001	Jun 3, 2005	Start Trial	Start Trial
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	Start Trial	Start Trial
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	Start Trial	Start Trial
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	Start Trial	Start Trial
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	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
Mexico	PA02012614	Start Trial
Denmark	1476138	Start Trial
Canada	2947528	Start Trial
Australia	2017254908	Start Trial
South Africa	200300990	Start Trial
European Patent Office	3288518	Start Trial
World Intellectual Property Organization (WIPO)	2016178131	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
1261586	C300524	Netherlands	Start Trial	PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
1730131	C01730131/02	Switzerland	Start Trial	PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1506211	42/2014	Austria	Start Trial	PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1412357	C300357	Netherlands	Start Trial	PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
0861666	07C0006	France	Start Trial	PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1506211	C01506211/02	Switzerland	Start Trial	PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	DO 77; 5006-2008	Slovakia	Start Trial	PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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