DrugPatentWatch Database Preview

GLUMETZA Drug Profile

« Back to Dashboard

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.

Summary for GLUMETZA

International Patents:	56
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	55
Clinical Trials:	42
Patent Applications:	6,506
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLUMETZA
Drug Sales Revenues:	Drug sales revenues for GLUMETZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLUMETZA
DailyMed Link:	GLUMETZA at DailyMed

See drug prices for GLUMETZA

See drug sales revenues for GLUMETZA

Recent Clinical Trials for GLUMETZA

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

Sponsor	Phase
University of Alberta	Phase 2
St. Justine's Hospital	Phase 2
Bristol-Myers Squibb	Phase 2

See all GLUMETZA clinical trials

Recent Litigation for GLUMETZA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Petitioner	Date
Endo Pharmaceutical Inc.	2014-04-17
Purdue Pharma L.P.	2014-01-24

See all GLUMETZA litigation

Pharmacology for GLUMETZA

Drug Class

Biguanide

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			Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	AB3	RX	Yes	No			Y	Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	AB3	RX	Yes	Yes			Y	Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	AB3	RX	Yes	No			Y	Y

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
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005

International Patents for GLUMETZA

Country	Patent Number	Estimated Expiration
Australia	2003211146
European Patent Office	1294363
Mexico	PA04008164
Germany	60101581
Denmark	1294363
Japan	2005526043

Supplementary Protection Certificates for GLUMETZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1532149	C300569	Netherlands		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		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		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	CA 2008 00035	Denmark		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		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