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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Johnson and Johnson
Fish and Richardson
McKesson
Daiichi Sankyo
Farmers Insurance
Colorcon
QuintilesIMS
Novartis

Generated: December 15, 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 thirty 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. One hundred suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Drug patent expirations by year for FORTAMET

Pharmacology for FORTAMET

Ingredient-typeBiguanides
Drug ClassBiguanide

Medical Subject Heading (MeSH) Categories for FORTAMET

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► Subscribe► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► SubscribeY► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► Subscribe► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes► Subscribe► Subscribe► Subscribe
Andrx Labs LlcFORTAMETmetformin hydrochlorideTABLET, 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
World Intellectual Property Organization (WIPO)0236100► Subscribe
South Korea20030061392► Subscribe
Spain2540972► Subscribe
European Patent Office2087889► Subscribe
European Patent Office1063971► Subscribe
Japan2007535557► Subscribe
Australia3101999► Subscribe
New Zealand525559► Subscribe
Brazil0115390► Subscribe
Japan2010159290► 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
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
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
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
C0006France► SubscribePRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
Johnson and Johnson
Fuji
Harvard Business School
Chinese Patent Office
Cerilliant
Fish and Richardson
McKinsey
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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