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Serving leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Medtronic
Cantor Fitzgerald
Novartis
Farmers Insurance
Harvard Business School
Accenture
Cipla
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Generated: October 22, 2017

DrugPatentWatch Database Preview

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in thirteen countries and twenty-nine supplementary protection certificates in eleven countries.

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

Summary for Tradename: FORTAMET

US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list46
Clinical Trials: see list34
Patent Applications: see list32
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FORTAMET at DailyMed

Pharmacology for Tradename: FORTAMET

Ingredient-typeBiguanides
Drug ClassBiguanide
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;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► Subscribe ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► Subscribe ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► Subscribe ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► Subscribe ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for FORTAMET

Drugname Dosage Strength RLD Submissiondate
metformin hydrochlorideExtended-release Tablets500 mg and 1000 mgFortamet10/14/2008

International Patent Family for Tradename: FORTAMET

Country Document Number Estimated Expiration
European Patent Office2087889► Subscribe
Canada2427195► Subscribe
China1158999► Subscribe
Brazil0115390► Subscribe
Japan4557424► Subscribe
European Patent Office1723948► Subscribe
Australia3083002► Subscribe
European Patent Office1746993► Subscribe
Australia2005239716► Subscribe
MexicoPA03003994► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FORTAMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131/02Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2013 00001Denmark► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
C/GB08/040United Kingdom► SubscribePRODUCT 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
C0028France► SubscribePRODUCT 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
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Farmers Insurance
Harvard Business School
Baxter
Julphar
Cantor Fitzgerald
AstraZeneca
Cipla
Colorcon

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 verifification 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.

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