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Last Updated: July 18, 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

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

SponsorPhase
Brigham and Women's HospitalPhase 2
Arthritis FoundationPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 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 021574-001 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
>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 92496 Luxembourg ⤷  Sign Up PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1730131 C01730131/02 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1261586 C300524 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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