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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
Medtronic
Chinese Patent Office
Cipla
QuintilesIMS
Colorcon
US Army
Express Scripts
Deloitte

Generated: November 18, 2017

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 seven 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:
1
Applicant:
1
Ingredient:
1
Patents:7
Therapeutic Class:Antibacterials
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 320MG BASE
Approval Date:Apr 4, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Apr 4, 2017Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
Patent:► SubscribePatent Expiration:Sep 21, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA

Expired Orange Book Patents for NDA: 021158

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003► Subscribe► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003► Subscribe► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Dow
Express Scripts
Queensland Health
US Department of Justice
Argus Health
Merck
Covington
Healthtrust
Farmers Insurance

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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