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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. One hundred and eleven 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:	3
Bulk Api Vendors:	52
Clinical Trials:	40
Patent Applications:	4,452
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GLUMETZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLUMETZA
DailyMed Link:	GLUMETZA at DailyMed

Pharmacology for GLUMETZA

Drug Class

Biguanide

Medical Subject Heading (MeSH) Categories for GLUMETZA

Hypoglycemic Agents

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

AK310686

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

D09AYI

D0D7LA

DB00331

Diabetosan

Diabex

Diabex (TN)

Diaformin (TN)

Diamin

Dianben

Dianben (TN)

Dimethylbiguanid

Dimethylbiguanide

Dimethylbiguanidine

Dimethyldiguanide

Dimethylguanylguanidine

DMBG

DMGG

DSSTox_CID_3270

DSSTox_GSID_23270

DSSTox_RID_76950

DTXSID2023270

EINECS 211-517-8

Fluamine

Flumamine

Fortamet

Fortamet (TN)

FT-0628266

Gen-Metformin

Glifage

Gliguanid

Glucophage

Glucophage (Salt/Mix)

Glucophage (TN)

Glumetza (TN)

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

MolPort-006-112-103

Mylan-Metformin

N-dimethylbiguanide

N-OCTYL L-2-PYRROLIDI-5-CARBOXYLATE

N,N-Dimethylbiguanide

N,N-Dimethyldiguanide

N,N-Dimethylguanylguanidin

N,N-dimethylguanylguanidine

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

Obimet (TN)

OR000602

OR026300

OR273467

OR300308

OR321414

PMS-Metformin

Prestwick0_000004

Prestwick1_000004

Prestwick2_000004

Prestwick3_000004

Ran-Metformin

Ratio-Metformin

Riomet (TN)

Sandoz Metformin

SBI-0206876.P001

SC-73311

SCHEMBL10276396

SCHEMBL8944

SCHEMBL9913821

Siofor

SMR000058277

SPBio_001928

STK011633

STL483693

STL484070

T5895664

Teva-Metformin

Tox21_302370

UNII-9100L32L2N

W-109589

XZWYZXLIPXDOLR-UHFFFAOYSA-N

ZINC12859773

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

Paragraph IV (Patent) Challenges for GLUMETZA

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	500 mg and 1000 mg

International Patents for GLUMETZA

Country	Document Number	Estimated Expiration
Japan	5069395
Canada	2476496
Germany	60101581
World Intellectual Property Organization (WIPO)	03035177
Israel	153464
Cyprus	1112517
World Intellectual Property Organization (WIPO)	2010064126

Supplementary Protection Certificates for GLUMETZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00037	Denmark		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
00357	Netherlands		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
C/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
2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
1506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
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