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Last Updated: May 2, 2024

GLUCOPHAGE XR Drug Patent Profile


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

Glucophage Xr is a drug marketed by Emd Serono Inc and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Glucophage Xr

A generic version of GLUCOPHAGE XR was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.

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Drug patent expirations by year for GLUCOPHAGE XR
Drug Prices for GLUCOPHAGE XR

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Recent Clinical Trials for GLUCOPHAGE XR

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

SponsorPhase
Arab Contractors Medical CentrePhase 4
Peking University First HospitalPhase 4
Turning Point Therapeutics, Inc.Phase 1

See all GLUCOPHAGE XR clinical trials

US Patents and Regulatory Information for GLUCOPHAGE XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 GLUCOPHAGE XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-004 Apr 11, 2003 ⤷  Try a Trial ⤷  Try a Trial
Emd Serono Inc GLUCOPHAGE XR metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021202-001 Oct 13, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GLUCOPHAGE XR

See the table below for patents covering GLUCOPHAGE XR around the world.

Country Patent Number Title Estimated Expiration
Australia 736951 ⤷  Try a Trial
African Intellectual Property Organization (OAPI) 11484 Biphasic controlled release delivery system for high solubility pharmaceuticals and method. ⤷  Try a Trial
China 1295467 ⤷  Try a Trial
European Patent Office 1063973 SYSTEME D'APPORT A LIBERATION LENTE BIPHASIQUE DESTINE A DES MEDICAMENTS A SOLUBILITE ELEVEE ET PROCEDE ASSOCIE (BIPHASIC CONTROLLED RELEASE DELIVERY SYSTEM FOR HIGH SOLUBILITY PHARMACEUTICALS AND METHOD) ⤷  Try a Trial
Eurasian Patent Organization 200000968 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLUCOPHAGE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C 2014 029 Romania ⤷  Try a Trial 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
1412357 PA2008013 Lithuania ⤷  Try a Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1532149 132013902118390 Italy ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1261586 12C0028 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
2498758 2020C/509 Belgium ⤷  Try a Trial PRODUCT NAME: QTRILMET - METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.