RIOMET ER Drug Patent Profile

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-eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® 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 24^th, 2002.

Summary for RIOMET ER

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	41
Patent Applications:	579
DailyMed Link:	RIOMET ER at DailyMed

Recent Clinical Trials for RIOMET ER

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
Washington State University	Early Phase 1
National Institutes of Health (NIH)	Early Phase 1

See all RIOMET ER clinical trials

US Patents and Regulatory Information for RIOMET ER

RIOMET ER is protected by one US patents.

Patents protecting 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		DISCN	Yes	No			Y

International Patents for RIOMET ER

See the table below for patents covering RIOMET ER around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3288518
European Patent Office	3288549
Mexico	2016014320	COMPOSICIONES DE SUSPENSION DE LIBERACION PROLONGADA. (EXTENDED RELEASE SUSPENSION COMPOSITIONS.)
Canada	3021475
Russian Federation	2017106010
World Intellectual Property Organization (WIPO)	2016178131
World Intellectual Property Organization (WIPO)	2016016845

Supplementary Protection Certificates for RIOMET ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	CA 2014 00037	Denmark		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
1506211	42/2014	Austria		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
1506211	132014902277722	Italy		PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2498758	301040	Netherlands		PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
2498758	PA2020003,C2498758	Lithuania		PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111