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Last Updated: May 7, 2021

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FORTAMET Drug Profile

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Which patents cover Fortamet, and when can generic versions of Fortamet launch?

Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in nine countries.

The generic ingredient in FORTAMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Seventy-nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Drug patent expirations by year for FORTAMET
Drug Prices for FORTAMET

See drug prices for FORTAMET

Recent Clinical Trials for FORTAMET

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

SponsorPhase
St. Baldrick's FoundationPhase 2
St. Jude Children's Research HospitalPhase 2
St. Justine's HospitalPhase 2

See all FORTAMET clinical trials

Pharmacology for FORTAMET
Drug ClassBiguanide
Paragraph IV (Patent) Challenges for FORTAMET
Tradename Dosage Ingredient NDA Submissiondate
FORTAMET TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride 021574 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   Get Started for $10   Get Started for $10   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 DISCN Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 AB2 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004   Get Started for $10   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004   Get Started for $10   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004   Get Started for $10   Get Started for $10
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004   Get Started for $10   Get Started for $10
>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
1261586 2012C/016 Belgium   Get Started for $10 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
1506211 PA2014026,C1506211 Lithuania   Get Started for $10 PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2498758 2090013-0 Sweden   Get Started for $10 PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113
1506211 C300677 Netherlands   Get Started for $10 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
1412357 PA2008013 Lithuania   Get Started for $10 PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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