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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

METFORMIN HYDROCHLORIDE Drug Profile

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When do Metformin Hydrochloride patents expire, and when can generic versions of Metformin Hydrochloride launch?

Metformin Hydrochloride is a drug marketed by 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, 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, and Zydus Pharms Usa. and is included in eighty-two NDAs.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Ninety-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Drug patent expirations by year for METFORMIN HYDROCHLORIDE
Recent Clinical Trials for METFORMIN HYDROCHLORIDE

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

SponsorPhase
Louisiana State University Health Sciences Center in New OrleansPhase 2/Phase 3
Columbia UniversityPhase 2/Phase 3
University of IowaPhase 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

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 METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 091184-002 Nov 1, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 077787-002 Aug 23, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077113-001 Sep 8, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Lupin Ltd METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 090692-002 Jun 29, 2011 AB2 RX No Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Moodys
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Boehringer Ingelheim
Harvard Business School
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Medtronic

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