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Last Updated: November 22, 2019

DrugPatentWatch Database Preview

GLUMETZA Drug Profile

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When do Glumetza patents expire, and what generic alternatives are available?

Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in eighteen countries.

The generic ingredient in GLUMETZA 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 GLUMETZA
Drug Prices for GLUMETZA

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Drug Sales Revenue Trends for GLUMETZA

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Recent Clinical Trials for GLUMETZA

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

See all GLUMETZA clinical trials

Recent Litigation for GLUMETZA

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District Court Litigation
Case NameDate
BAUSCH HEALTH IRELAND LIMITED v. APOTEX INC.2019-06-28
In re: Depomed, Inc.2015-12-30
Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-15

See all GLUMETZA litigation

PTAB Litigation
PetitionerDate
Endo Pharmaceutical Inc.2014-04-17
Purdue Pharma L.P.2014-01-24

See all GLUMETZA litigation

Pharmacology for GLUMETZA
Drug ClassBiguanide
Synonyms for GLUMETZA
[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
1,1-Dimethyl biguanide
1,1-Dimethylbiguanide
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-(diaminomethylidene)-1,1-dimethylguanidine
3-(diaminomethylidene)-1,1-dimethylguanidine;hydrochloride
3-[bis(azanyl)methylidene]-1,1-dimethyl-guanidine;hydrochloride
3-carbamimidoyl-1,1-dimethyl-guanidine
657-24-9
657M249
9100L32L2N
A19551
AB2000590
AC1L1HE4
AKOS000121065
AKOS005206848
AKOS015966566
AN-47122
BBL012337
BDBM50229665
BDBM57047
BIDD:GT0697
BIGUANIDE, 1,1-DIMETHYL-
BPBio1_000009
BRD-K79602928-003-04-1
BRD-K79602928-003-08-2
BSPBio_000007
BSPBio_002314
C07151
C4H11N5
CAS-1115-70-4
CAS-657-24-9
CCG-102605
CCRIS 9321
CHEBI:6801
CHEMBL1431
cid_14219
cMAP_000016
CTK2F2882
D04966
DB00331
Diabex
Dianben
Dimethylbiguanid
Dimethylbiguanide
Dimethyldiguanide
Dimethylguanylguanidine
DMBG
DMGG
DSSTox_CID_3270
DSSTox_GSID_23270
DSSTox_RID_76950
DTXSID2023270
EINECS 211-517-8
Fluamine
Flumamine
Fortamet
FT-0628266
Gen-Metformin
Glifage
Gliguanid
Glucophage
Glucophage (Salt/Mix)
Glycon
GTPL4503
GTPL4779
Haurymelin
HMS2089D19
HSCI1_000295
Imidodicarbonimidic diamide-, N,N-dimethyl-
Imidodicarbonimidic diamide, N,N-dimethyl-
Imidodicarbonimidicdiamide, N,N-dimethyl-
Islotin
K070
KBio2_002310
KBio2_004878
KBio2_007446
KBio3_002790
KBioGR_002310
KBioSS_002312
LA 6023 (Salt/Mix)
LA-6023
LS-43899
MCULE-7393156510
Melbin
metformin
Metformin (USAN/INN)
Metformin [USAN:INN:BAN]
Metformin base
Metformina
Metformina [DCIT]
Metformina [Spanish]
Metformine
Metformine [INN-French]
Metforminum
Metforminum [INN-Latin]
Metiguanide
MF8
MLS000028493
MolPort-002-929-560
MolPort-005-767-418
Mylan-Metformin
N-dimethylbiguanide
N,N-Dimethylbiguanide
N,N-Dimethyldiguanide
N,N-Dimethylguanylguanidin
N,N-dimethylimidodicarbonimidic diamide
n',n'-dimethylbiguanide
N1,N1-Dimethylbiguanide
NCGC00016564-01
NCGC00016564-02
NCGC00016564-03
NCGC00016564-05
NCGC00016564-07
NCGC00188959-01
NCGC00255255-01
NNDG
Nu-Metformin
Obimet
PMS-Metformin
Prestwick0_000004
Prestwick1_000004
Prestwick2_000004
Prestwick3_000004
Ran-Metformin
Ratio-Metformin
Sandoz Metformin
SBI-0206876.P001
SC-73311
SCHEMBL10276396
SCHEMBL8944
SCHEMBL9913821
Siofor
SMR000058277
SPBio_001928
STK011633
STL483693
STL484070
Teva-Metformin
Tox21_302370
UNII-9100L32L2N
W-109589
XZWYZXLIPXDOLR-UHFFFAOYSA-N
ZINC12859773
Paragraph IV (Patent) Challenges for GLUMETZA
Tradename Dosage Ingredient NDA Submissiondate
GLUMETZA TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021748 2009-07-27

US Patents and Regulatory Information for GLUMETZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No   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 GLUMETZA

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   Start Trial   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   Start Trial   Start Trial
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   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 GLUMETZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2012022 Lithuania   Start Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149 C300569 Netherlands   Start Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1412357 SPC/GB08/040 United Kingdom   Start Trial 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
1412357 DO 77; 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357 CA 2008 00035 Denmark   Start Trial PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1506211 179 5017-2014 Slovakia   Start Trial PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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