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Serving leading biopharmaceutical companies globally:

Novartis
Farmers Insurance
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Healthtrust
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Baxter
Merck
Cantor Fitzgerald
UBS
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021574

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NDA 021574 describes FORTAMET, which 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. Additional details are available on the FORTAMET profile page.

The generic ingredient in FORTAMET is metformin hydrochloride. There are forty-eight drug master file entries for this compound. One hundred and nine suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021574
Tradename:FORTAMET
Applicant:Andrx Labs Llc
Ingredient:metformin hydrochloride
Patents:6
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 021574
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 021574
Suppliers and Packaging for NDA: 021574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2719 N 0591-2719-60
FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574 NDA AUTHORIZED GENERIC Actavis Pharma, Inc. 0591-2720 N 0591-2720-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Apr 27, 2004TE:AB2RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 17, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION

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Fuji
Federal Trade Commission
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US Department of Justice
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Daiichi Sankyo
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Dow

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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