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Federal Trade Commission
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Generated: May 24, 2018

DrugPatentWatch Database Preview

Metformin hydrochloride - Generic Drug Details

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What are the generic drug 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, 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, 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-five 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.

Metformin hydrochloride has one hundred and twenty-three patent family members in thirty-three countries.

There are forty-eight drug master file entries for metformin hydrochloride. One hundred and thirteen suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for metformin hydrochloride
Ingredient-typeBiguanides
Drug ClassBiguanide
Medical Subject Heading (MeSH) Categories for metformin hydrochloride
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
➤ Sign Up➤ Sign Up500MGTABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
➤ Sign Up➤ Sign Up1GM; EQ 50MG BASETABLET, 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
Watson Labs METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 075979-001 Jan 24, 2002 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Atlas Pharms Llc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 076033-001 Jan 24, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE metformin hydrochloride; pioglitazone hydrochloride TABLET;ORAL 091273-002 Apr 16, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ACTOPLUS MET XR metformin hydrochloride; pioglitazone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022024-001 May 12, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021574-002 Apr 27, 2004 ➤ Sign Up ➤ Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ➤ 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

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Non-Orange Book US Patents for metformin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,128,957 Modified release compositions of at least one form of tramadol ➤ Sign Up
6,559,187 Liquid formulation of metformin ➤ Sign Up
8,158,147 Modified release formulations of at least one form of tramadol ➤ Sign Up
2,005,182,056 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for metformin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0028 France ➤ Sign Up 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
/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
77; 5006-2008 Slovakia ➤ Sign Up PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
C/GB08/040 United Kingdom ➤ Sign Up PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Chinese Patent Office
Daiichi Sankyo
Federal Trade Commission
McKinsey
Fuji
Harvard Business School
Dow
US Department of Justice

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