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Last Updated: April 6, 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-six 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 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
1412357 DO 77; 5006-2008 Slovakia   Start Trial PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586 C01261586/02 Switzerland   Start Trial PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1261586 132012902044560 Italy   Start Trial PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Boehringer Ingelheim
Moodys
AstraZeneca
Dow

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