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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
UBS
Argus Health
US Army
Harvard Business School
Fish and Richardson
Daiichi Sankyo
Accenture

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021158

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NDA 021158 describes FACTIVE, which is a drug marketed by Lg Chem Ltd and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FACTIVE profile page.

The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Additional details are available on the gemifloxacin mesylate profile page.
Summary for 021158
Tradename:FACTIVE
Applicant:Lg Chem Ltd
Ingredient:gemifloxacin mesylate
Patents:6
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 320MG BASE
Approval Date:Apr 4, 2003TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
Patent:➤ Try a Free TrialPatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
Patent:➤ Try a Free TrialPatent Expiration:Sep 14, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA

Expired US Patents for NDA 021158

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ 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:

Merck
Fish and Richardson
Harvard Business School
Accenture
Chubb
US Army
Dow
Chinese Patent Office
McKinsey

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