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METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Metformin hydrochloride is the generic ingredient in sixteen branded drugs marketed by Sun Pharm Inds Ltd, Andrx Labs Llc, Bristol Myers Squibb, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Alignscience Pharma, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi Pharm Co, Granules India Ltd, Impax Labs, Intellipharmaceutics, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Mylan, Mylan Pharms Inc, Nostrum Labs Inc, Nostrum Pharms Llc, Prinston Inc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Sun Pharm Industries, Sun Pharma Global, Teva, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Laurus Labs Ltd, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Takeda Pharms Usa, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, and Merck Sharp Dohme, and is included in ninety-seven NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are forty-eight drug master file entries for metformin hydrochloride. One hundred and fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for METFORMIN HYDROCHLORIDE

US Patents:	31
Tradenames:	16
Applicants:	58
NDAs:	97
Drug Master File Entries:	48
Suppliers / Packagers:	114
Bulk Api Vendors:	114
Clinical Trials:	1,987
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

Pharmacology for METFORMIN HYDROCHLORIDE

Ingredient-type	Biguanides
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

BB_SC-5098

BC206669

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

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, British Pharmacopoeia (BP) Reference Standard

Metformin hydrochloride, European Pharmacopoeia (EP) Reference Standard

Metformin hydrochloride, pharmaceutical secondary standard; traceable to USP and PhEur

Metformin hydrochloride, United States Pharmacopeia (USP) Reference Standard

Metformin monohydrochloride

Metiguanide monohydrochloride

Metolmin

Metomin

MFCD00012582

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

OR145246

Pharmakon1600-01505814

Prestwick_519

Q-201360

Riomet

Risidon

RP22848

RTR-002281

s1950

SC-17468

SCHEMBL10325580

SCHEMBL22977

Siamformet

SMR000058277

SPECTRUM1505814

ST24048701

SY001217

Thiabet

TL8000340

Tox21_110498

Tox21_110498_1

TR-002281

TRA0069243

UNII-786Z46389E

Walaphage

Z2244578658

Tentative approvals for METFORMIN HYDROCHLORIDE

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

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
Granules India	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	090564-001	Apr 22, 2010	AB	RX	No	No
Sun Pharm Inds Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075967-003	Jan 29, 2002	AB	RX	No	No
Lupin Ltd	REPAGLINIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; repaglinide	TABLET;ORAL	200624-001	Jul 15, 2015		DISCN	No	No
Mylan	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076650-001	Sep 13, 2005		DISCN	No	No
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes			Y	Y
Takeda Pharms Usa	ACTOPLUS MET XR	metformin hydrochloride; pioglitazone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022024-001	May 12, 2009		RX	Yes	No			Y
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes			Y

Expired US Patents for METFORMIN HYDROCHLORIDE

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
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Bristol Myers Squibb	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003
Bristol Myers Squibb	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000
Bristol Myers Squibb	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000

International Patents for METFORMIN HYDROCHLORIDE

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03035177
Brazil	0113102
Australia	2005239716
Japan	2004505913
World Intellectual Property Organization (WIPO)	03072025
Japan	2009040787
Mexico	PA03001157

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
496	Luxembourg		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
00524	Netherlands		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:
/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID