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FORTAMET Drug Profile

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Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA. It is available from four suppliers. 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-two suppliers are listed for this compound. There is one tentative approval 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 list31
Patent Applications: see list6,414
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 Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004RXYes6,790,459► subscribe ► subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-001Apr 27, 2004RXNo6,790,459► subscribe ► subscribe
Andrx Labs Llc
FORTAMET
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021574-002Apr 27, 2004RXYes6,099,859► 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
European Patent Office1063971► subscribe
European Patent Office1335708► subscribe
Japan2013237689► 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
/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
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
00524Netherlands► subscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
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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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