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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Dow
Fuji
Fish and Richardson
Queensland Health
Deloitte
Mallinckrodt
Cipla
Daiichi Sankyo

Generated: April 25, 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 three 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 twelve 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

Expired US Patents for NDA 021574

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 ➤ Try a Free Trial ➤ Try a Free Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-002 Apr 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Andrx Labs Llc FORTAMET metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021574-001 Apr 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Fish and Richardson
Cantor Fitzgerald
Healthtrust
QuintilesIMS
AstraZeneca
Chubb
Covington

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