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Last Updated: May 24, 2022

FORTAMET Drug Patent 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.

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
National Heart, Lung, and Blood Institute (NHLBI)Phase 1
University of Colorado, DenverPhase 1
St. Jude Children's Research HospitalPhase 2

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 See Plans and Pricing See Plans and Pricing
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FORTAMET

See the table below for patents covering FORTAMET around the world.

Country Patent Number Title Estimated Expiration
Brazil 0115390 See Plans and Pricing
Japan 5427677 See Plans and Pricing
European Patent Office 1063971 COMPRIMES ORAUX A NOYAU MONOLITHIQUE A LIBERATION CONTROLEE (CONTROLLED RELEASE ORAL TABLET HAVING A UNITARY CORE) See Plans and Pricing
China 1308520 See Plans and Pricing
Australia 3083002 See Plans and Pricing
European Patent Office 1746993 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FORTAMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2498758 2090013-0 Sweden See Plans and Pricing 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
1261586 12C0028 France See Plans and Pricing 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
1261586 15/2012 Austria See Plans and Pricing 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
1412357 DO 77; 5006-2008 Slovakia See Plans and Pricing PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2498758 CA 2020 00017 Denmark See Plans and Pricing PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1412357 SPC/GB08/040 United Kingdom See Plans and Pricing PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Moodys
Boehringer Ingelheim
AstraZeneca
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.