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

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

FORTAMET Drug Profile

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Which patents cover Fortamet, and when can generic versions of Fortamet launch?

Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in nine countries.

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

Drug patent expirations by year for FORTAMET
Drug Prices for FORTAMET

See drug prices for FORTAMET

Recent Clinical Trials for FORTAMET

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

SponsorPhase
University of AlbertaPhase 2
St. Justine's HospitalPhase 2
Bristol-Myers SquibbPhase 2

See all FORTAMET clinical trials

Recent Litigation for FORTAMET

Identify potential future generic entrants

District Court Litigation
Case NameDate
Shionogi Inc. v. Amneal Pharmaceuticals, LLC2018-10-11
SHIONOGI INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2018-08-16
Shionogi Inc. v. Qingdao Baheal Pharmaceutical Co. Ltd.2017-09-22

See all FORTAMET 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 FORTAMET litigation

Pharmacology for FORTAMET
Drug ClassBiguanide
Synonyms for FORTAMET
(E)-2-carbamimidoyl-1,1-dimethylguanidine hydrochloride
[14C]-metformin
[14C]metformin
{[amino(dimethylamino)methylidene]amino}methanimidamide
1-[(diaminomethylidene)amino]-N,N-dimethylmethanimidamide
1-[(E)-amino(dimethylamino)methylidene]guanidine
1-carbamimidamido-N,N-dimethylmethanimidamide
1-dimethylbiguanide hydrochloride
1,1-Dimethyl biguanide
1,1-Dimethylbiguanide
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
15673-EP2269977A2
15673-EP2269989A1
15673-EP2270007A1
15673-EP2270011A1
15673-EP2272825A2
15673-EP2272834A1
15673-EP2272841A1
15673-EP2275108A1
15673-EP2275414A1
15673-EP2280001A1
15673-EP2287165A2
15673-EP2287166A2
15673-EP2292228A1
15673-EP2292620A2
15673-EP2295406A1
15673-EP2295409A1
15673-EP2295411A1
15673-EP2295422A2
15673-EP2298742A1
15673-EP2298769A1
15673-EP2298772A1
15673-EP2298776A1
15673-EP2298779A1
15673-EP2301533A1
15673-EP2301923A1
15673-EP2301929A1
15673-EP2301935A1
15673-EP2301936A1
15673-EP2305648A1
15673-EP2305674A1
15673-EP2308839A1
15673-EP2308847A1
15673-EP2308878A2
15673-EP2314576A1
15673-EP2314588A1
15673-EP2316470A2
3-(diaminomethylene)-1,1-dimethyl-guanidine
3-(diaminomethylene)-1,1-dimethyl-guanidine hydrochloride
3-(diaminomethylene)-1,1-dimethyl-guanidine;hydrochloride
3-(diaminomethylidene)-1,1-dimethylguanidine
3-(diaminomethylidene)-1,1-dimethylguanidine hydrochloride
3-(diaminomethylidene)-1,1-dimethylguanidine;hydrochloride
3-[bis(azanyl)methylidene]-1,1-dimethyl-guanidine;hydrochloride
3-carbamimidoyl-1,1-dimethyl-guanidine
3-carbamimidoyl-1,1-dimethylguanidine;hydrochloride
56258-19-6
657-24-9
657M249
786Z46389E
9100L32L2N
A19551
AB0004717
AB1009370
AB2000590
AC-2075
AC1L1HE4
AC1L23D5
ACMC-20ap7s
AI3-51264
AK163172
AKOS000121065
AKOS005206848
AKOS015894259
AKOS015966566
AN-47122
AN-8747
API0003318
Apo-Metformin
AX8041182
BBL012337
BC206669
BCP03594
BDBM50229665
BDBM57047
Benofomin
BG0401
BIDD:GT0697
BIGUANIDE, 1,1-DIMETHYL-
BIGUANIDE, 1,1-DIMETHYL-, HYDROCHLORIDE
Biguanide, 1,1-dimethyl-, monohydrochloride
Biguanide, 1,1-dimethyl-, monohydrochloride (8CI)
Biguanide,1-dimethyl-, monohydrochloride
Biocos
BP-12830
BPBio1_000009
BRD-K79602928-003-04-1
BRD-K79602928-003-08-2
BSPBio_000007
BSPBio_002314
C07151
C4H11N5
C4H11N5.HCl
C4H12ClN5
CAS-1115-70-4
CAS-657-24-9
CCG-102605
CCG-208004
CCRIS 9321
CHEBI:6801
CHEBI:6802
CHEMBL1431
CHEMBL1703
cid_14219
Cidophage
cMAP_000016
CS-1851
CTK2F2882
CTK8C6229
D 15095
D.B.I
D.B.I.
D00944
D04966
Dabex
DB-018697
DB00331
Denkaform
Dextin
Diabefagos
Diaberit
Diabesin
Diabetex
Diabetmin
Diabetosan
Diabex
Diaformin
Diamin
Dianben
Diaphage
Diformin
Diformin Retard
Dimethylbiguanid
Dimethylbiguanide
Dimethylbiguanide hydrochloride
Dimethyldiguanide
Dimethylguanylguanidine
DMBG
DMBG hydrochloride
DMGG
DMGG hydrochloride
DSSTox_CID_17246
DSSTox_CID_3270
DSSTox_GSID_23270
DSSTox_GSID_37246
DSSTox_RID_76950
DSSTox_RID_79314
DTXSID2023270
DTXSID9037246
EC 214-230-6
EINECS 211-517-8
EINECS 214-230-6
F2173-0894
Fluamine
Flumamine
Fornidd
FT-0628265
FT-0628266
Geamet
Gen-Metformin
Glibomet
Glifage
Gliguanid
Glucofago
Glucoform
Glucoliz
Glucomet
Glucomine
Gluconil
Glucophage
Glucophage (Salt/Mix)
Glucophage (TN)
Glucophage 850
Glucophage Forte
Glucophage Retard
Glucophage XR
Glucophage-Mite
Gluformin
Glumetza
Glupermin
Glyciphage
Glycon
Glycoran
Glyformin
GP2747
GTPL4503
GTPL4779
Haurymelin
Haurymellin hydrochloride
HMS1568A09
HMS1922H14
HMS2089D19
HSCI1_000295
HSDB 7080
HY-17471A
I05-0228
I14-7880
I506
Imidodicarbonimidic diamide-, N,N-dimethyl-
Imidodicarbonimidic diamide, N,N-dimethyl-
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride
Imidodicarbonimidic diamide, N,N-dimethyl-, monohydrochloride (9CI)
Imidodicarbonimidic diamide,N-dimethyl-, monohydrochloride
Imidodicarbonimidicdiamide, N,N-dimethyl-
Islotin
Islotin retard
J10020
J10377
Jsp000870
K070
KBio2_002310
KBio2_004878
KBio2_007446
KBio3_002790
KBioGR_002310
KBioSS_002312
KS-000006B5
KS-1272
KSC926E2T
LA 6023
LA 6023 (Salt/Mix)
LA 6063
LA-6023
LS-43899
LS-43900
M-2922
M2009
MCULE-7393156510
MCULE-9784059944
Meglucon
Meguan
Melbin
Mescorit
Metbay
Metforal
metformin
Metformin (hydrochloride)
Metformin (USAN/INN)
Metformin [USAN:INN:BAN]
Metformin base
Metformin HCL
Metformin HCl ER
Metformin HCl(Glucophage)
Metformin hydrochloride
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
Metformina
Metformina [DCIT]
Metformina [Spanish]
Metformine
Metformine [INN-French]
Metforminum
Metforminum [INN-Latin]
Metiguanide
Metiguanide monohydrochloride
Metolmin
Metomin
MF8
MFCD00012582
MFCD00012582 (97+%)
MLS000028493
MLS002222221
MolPort-000-771-764
MolPort-002-929-560
MolPort-005-767-418
MolPort-039-227-817
Mylan-Metformin
N-[amino(dimethylamino)methylidene]guanidine hydrochloride
N-dimethylbiguanide
N,N-Dimethylbiguanide
N,N-Dimethylbiguanide hydrochloride
N,N-Dimethyldiguanide
N,N-Dimethylguanylguanidin
N,N-dimethylimidodicarbonimidic diamide
N,N-dimethylimidodicarbonimidic diamide hydrochloride
N,N-Dimethylimidodicarbonimidic diamine
n',n'-dimethylbiguanide
N',N'-dimethylbiguanide hydrochloride
N1,N1-Dimethylbiguanide
N1,N1-Dimethylbiguanide hydrochloride
NCGC00016564-01
NCGC00016564-02
NCGC00016564-03
NCGC00016564-05
NCGC00016564-06
NCGC00016564-07
NCGC00095185-01
NCGC00095185-02
NCGC00188959-01
NCGC00255255-01
NNDG
Novo-Metformin
NSC 91485
NSC-759262
NSC-91485
NSC759262
NSC91485
Nu-Metformin
Obimet
OETHQSJEHLVLGH-UHFFFAOYSA-N
OR322044
Pharmakon1600-01505814
PMS-Metformin
Prestwick_519
Prestwick0_000004
Prestwick1_000004
Prestwick2_000004
Prestwick3_000004
Q-201360
Ran-Metformin
Ratio-Metformin
Riomet
Risidon
RP22848
RTR-002281
s1950
Sandoz Metformin
SB19704
SBI-0206876.P001
SC-17468
SC-73311
SCHEMBL10276396
SCHEMBL10325580
SCHEMBL20140191
SCHEMBL22977
SCHEMBL8944
SCHEMBL9913821
Siamformet
Siofor
SMR000058277
SPBio_001928
SPECTRUM1505814
SR-05000001764-2
ST24048701
STK011633
STL483693
STL484070
SY001217
Teva-Metformin
Thiabet
TL8000340
Tox21_110498
Tox21_110498_1
Tox21_302370
TR-002281
TRA0069243
UNII-786Z46389E
UNII-9100L32L2N
W-109589
Walaphage
XZWYZXLIPXDOLR-UHFFFAOYSA-N
Z2244578658
ZINC12859773
Paragraph IV (Patent) Challenges for FORTAMET
Tradename Dosage Ingredient NDA Submissiondate
FORTAMET TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021574 2008-10-14

US Patents and Regulatory Information for FORTAMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 DISCN Yes No   Start Trial   Start Trial 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 FORTAMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 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
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FORTAMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 2012C/016 Belgium   Start Trial PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1506211 CR 2014 00037 Denmark   Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Mallinckrodt
Boehringer Ingelheim
McKinsey
AstraZeneca

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