Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Johnson and Johnson
AstraZeneca
Merck
Medtronic

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

METFORMIN HYDROCHLORIDE - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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.

Recent Clinical Trials for METFORMIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Georgetown UniversityPhase 2/Phase 3
Wake Forest UniversityPhase 2/Phase 3
National Institute on Aging (NIA)Phase 2/Phase 3

See all METFORMIN HYDROCHLORIDE clinical trials

Recent Litigation for METFORMIN HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
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, LLC2018-10-11

See all METFORMIN HYDROCHLORIDE litigation

PTAB Litigation
PetitionerDate
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 Trial500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GM; EQ 100MG BASETABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1GM; EQ 50MG BASETABLET, 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 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
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

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

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

Supplementary Protection Certificates for METFORMIN HYDROCHLORIDE

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

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
Dow
Harvard Business School
AstraZeneca
Mallinckrodt

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 verifification 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.