RIOMET Drug Patent Profile
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Which patents cover Riomet, and what generic alternatives are available?
Riomet is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.
The generic ingredient in RIOMET 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 Riomet
A generic version of RIOMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24th, 2002.
Summary for RIOMET
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 40 |
Patent Applications: | 579 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for RIOMET |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RIOMET |
What excipients (inactive ingredients) are in RIOMET? | RIOMET excipients list |
DailyMed Link: | RIOMET at DailyMed |
Recent Clinical Trials for RIOMET
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institutes of Health (NIH) | Early Phase 1 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Early Phase 1 |
Washington State University | Early Phase 1 |
Pharmacology for RIOMET
Drug Class | Biguanide |
Anatomical Therapeutic Chemical (ATC) Classes for RIOMET
Paragraph IV (Patent) Challenges for RIOMET
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
RIOMET | Oral Solution | metformin hydrochloride | 500 mg/5 mL | 021591 | 1 | 2018-02-02 |
US Patents and Regulatory Information for RIOMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ranbaxy | RIOMET | metformin hydrochloride | SOLUTION;ORAL | 021591-001 | Sep 11, 2003 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm | RIOMET ER | metformin hydrochloride | FOR SUSPENSION, EXTENDED RELEASE;ORAL | 212595-001 | Aug 29, 2019 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 RIOMET
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Ranbaxy | RIOMET | metformin hydrochloride | SOLUTION;ORAL | 021591-001 | Sep 11, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for RIOMET
See the table below for patents covering RIOMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2416767 | ⤷ Try a Trial | |
Israel | 154307 | ⤷ Try a Trial | |
Mexico | PA03001157 | FORMULACION LIQUIDA DE METFORMINA. (LIQUID FORMULATION OF METFORMIN.) | ⤷ Try a Trial |
Japan | 2004505913 | ⤷ Try a Trial | |
Brazil | 0113102 | ⤷ Try a Trial | |
European Patent Office | 1387675 | ⤷ Try a Trial | |
Slovakia | 2102003 | Liquid formulation of metformin | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RIOMET
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 |
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1261586 | 2012C/016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |