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Generated: October 23, 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. It is available from two suppliers. 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. Two suppliers are listed 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021158
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 021158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FACTIVE gemifloxacin mesylate TABLET;ORAL 021158 NDA Merus Labs International Inc. 44001-321 44001-321-05 5 TABLET in 1 BLISTER PACK (44001-321-05)
FACTIVE gemifloxacin mesylate TABLET;ORAL 021158 NDA Merus Labs International Inc. 44001-321 44001-321-07 7 TABLET in 1 BLISTER PACK (44001-321-07)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 320MG BASE
Approval Date:Apr 4, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
Patent:➤ Sign UpPatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
Patent:➤ Sign UpPatent 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 ➤ Sign Up ➤ Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Sign Up ➤ Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Sign Up ➤ Sign Up
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Cantor Fitzgerald
Federal Trade Commission
Queensland Health
Cerilliant
Express Scripts
Farmers Insurance

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