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Generated: June 27, 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.

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

Summary for Tradename: FORTAMET

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list46
Clinical Trials: see list33
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, 2004AB2RXYesYes6,495,162► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo6,099,859► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004AB2RXYesYes7,919,116► SubscribeY ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo6,790,459► Subscribe ► Subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004AB2RXYesNo6,866,866► SubscribeY ► Subscribe
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Paragraph IV activity 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
Australia739226► Subscribe
European Patent Office1746993► Subscribe
China1158999► Subscribe
New Zealand525559► Subscribe
Australia3083002► 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
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
00677Netherlands► SubscribePRODUCT 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
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
UBS
Accenture
Boehringer Ingelheim
Queensland Health
Moodys
McKinsey
Cantor Fitzgerald
Cerilliant
Novartis

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