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Last Updated: July 24, 2024

FORTAMET Drug Patent Profile


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Which patents cover Fortamet, and what generic alternatives are available?

Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA.

The generic ingredient in FORTAMET 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fortamet

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

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Drug patent expirations by year for FORTAMET
Drug Prices for FORTAMET

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Recent Clinical Trials for FORTAMET

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SponsorPhase
Arthritis FoundationPhase 2
Brigham and Women's HospitalPhase 2
University of Colorado, DenverPhase 1

See all FORTAMET clinical trials

Paragraph IV (Patent) Challenges for FORTAMET
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORTAMET Extended-release Tablets metformin hydrochloride 500 mg and 1000 mg 021574 1 2008-10-14

US Patents and Regulatory Information for FORTAMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 AB2 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 FORTAMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FORTAMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 122014000071 Germany ⤷  Sign Up 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
1412357 CA 2008 00035 Denmark ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1506211 C 2014 029 Romania ⤷  Sign Up 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
1506211 C01506211/02 Switzerland ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2498758 122020000018 Germany ⤷  Sign Up PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211 122014000070 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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