FORTAMET Drug Patent Profile

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. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fortamet

A generic version of FORTAMET was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24^th, 2002.

Summary for FORTAMET

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	41
Patent Applications:	680
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FORTAMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORTAMET
What excipients (inactive ingredients) are in FORTAMET?	FORTAMET excipients list
DailyMed Link:	FORTAMET at DailyMed

See drug prices for FORTAMET

Recent Clinical Trials for FORTAMET

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1
University of Colorado, Denver	Phase 1
St. Baldrick's Foundation	Phase 2

See all FORTAMET clinical trials

Pharmacology for FORTAMET

Drug Class

Biguanide

Anatomical Therapeutic Chemical (ATC) Classes for FORTAMET

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004		DISCN	Yes	No

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	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004

International Patents for FORTAMET

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1723948
World Intellectual Property Organization (WIPO)	2005107750
European Patent Office	2087889	Comprimé oral à libération contrôlée doté d'un coeur unitaire (Controlled release oral tablet having a unitary core)
Brazil	0115390
New Zealand	525559	Controlled release metformin compositions for the reduction of serum glucose levels in human patients with NIDDM
World Intellectual Property Organization (WIPO)	9947125

Supplementary Protection Certificates for FORTAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CR 2014 00037	Denmark		PRODUCT 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
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
2498758	LUC00152	Luxembourg		PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1532149	92128	Luxembourg		PRODUCT 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
2498758	2090013-0	Sweden		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
1412357	50/2008	Austria		PRODUCT 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