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Baxter
McKesson
Harvard Business School

Last Updated: January 20, 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-four 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

  Start Trial

A generic version of RIOMET ER was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 20th, 2020.

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
Innovent Biologics (Suzhou) Co. Ltd.Phase 2
Tianjin Medical University Cancer Institute and HospitalPhase 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 C 2014 029 Romania   Start 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
1532149 PA2012022 Lithuania   Start Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1506211 PA2014026,C1506211 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586 12C0028 France   Start 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
1506211 300677 Netherlands   Start Trial 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 DO 77; 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Baxter
Merck
Harvard Business School
Dow

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