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Last Updated: May 7, 2021

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Seventy-nine 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
St. Baldrick's FoundationPhase 2
St. Jude Children's Research HospitalPhase 2
University of AlbertaPhase 2

See all GLUMETZA clinical trials

Pharmacology for GLUMETZA
Drug ClassBiguanide
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   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>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   Get Started for $10   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005   Get Started for $10   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   Get Started for $10   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   Get Started for $10   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005   Get Started for $10   Get Started for $10
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GLUMETZA

Country Patent Number Estimated Expiration
Israel 153464   Get Started for $10
World Intellectual Property Organization (WIPO) 03035177   Get Started for $10
Australia 8138698   Get Started for $10
Japan 2003535886   Get Started for $10
Denmark 1294363   Get Started for $10
Canada 2412671   Get Started for $10
Australia 3989301   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for GLUMETZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1261586 2012C/016 Belgium   Get Started for $10 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
1506211 PA2014026,C1506211 Lithuania   Get Started for $10 PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2498758 2090013-0 Sweden   Get Started for $10 PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1506211 C300677 Netherlands   Get Started for $10 PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1412357 PA2008013 Lithuania   Get Started for $10 PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1506211 C 2014 029 Romania   Get Started for $10 PRODUCT NAME: COMBINATIE DE DAPAGLIFLOZIN SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTUIA SI METFORMINA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/900; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/900; DATE OF FIRST AUTHORISATION IN EEA: 20140116
1506211 300677 Netherlands   Get Started for $10 PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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