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Last Updated: August 14, 2020

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RIOMET ER Drug Profile

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

Riomet Er is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Riomet Er

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

  Start Trial

Summary for RIOMET ER
International Patents:29
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 32
Formulation / Manufacturing:see details
DailyMed Link:RIOMET ER at DailyMed
Drug patent expirations by year for RIOMET ER
Recent Clinical Trials for RIOMET ER

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

SponsorPhase
Tianjin Medical University Cancer Institute and HospitalPhase 2
Innovent Biologics (Suzhou) Co. Ltd.Phase 2
National Cancer Institute (NCI)Phase 1

See all RIOMET ER clinical trials

Pharmacology for RIOMET ER
Drug ClassBiguanide

US Patents and Regulatory Information for RIOMET ER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm RIOMET ER metformin hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 212595-001 Aug 29, 2019 RX Yes Yes   Start Trial   Start Trial 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

Supplementary Protection Certificates for RIOMET ER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 42/2014 Austria   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
1261586 1290013-0 Sweden   Start Trial PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
1506211 CR 2014 00037 Denmark   Start Trial 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
2498758 PA2020003 Lithuania   Start Trial PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1412357 C 2008 016 Romania   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
1506211 122014000070 Germany   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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