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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Queensland Health
QuintilesIMS
Citi
Fish and Richardson
Mallinckrodt
US Department of Justice
Cantor Fitzgerald
Julphar
Chubb

Generated: July 20, 2017

DrugPatentWatch Database Preview

FACTIVE Drug Profile

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What is the patent landscape for Factive, and what generic Factive alternatives are available?

Factive is a drug marketed by Lg Chem Ltd and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in forty countries.

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 Tradename: FACTIVE

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list28
Clinical Trials: see list2
Patent Applications: see list139
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:FACTIVE at DailyMed

Pharmacology for Tradename: FACTIVE

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes6,723,734► SubscribeYY ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes6,331,550► Subscribe ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes6,262,071► Subscribe ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes5,776,944► SubscribeYY ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes6,803,376► SubscribeYY ► Subscribe
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Expired Patents for Tradename: FACTIVE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,633,262► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,962,468► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,776,944► Subscribe
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Paragraph IV activity for: FACTIVE

Drugname Dosage Strength RLD Submissiondate
gemifloxacin mesylateTablets320 mgFactive3/4/2008

Non-Orange Book Patents for Tradename: FACTIVE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,962,468 7-(4-aminomethyl-3-methyloxyiminopyrrolidin-1-yl)-1- cyclopropyl-6-fluoro-4-oxo-1, 4-dihydro-1, 8-naphthyridine-3-carboxylic acid and the process for the preparation thereof► Subscribe
6,279,257 Flush mounting security frames and hardware► Subscribe
5,633,262 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime) pyrrolidine substituent and processes for preparing thereof► Subscribe
7,700,617Salt of naphthyridine carboxylic acid derivative► Subscribe
6,659,418 Positioning & locking hanging system► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: FACTIVE

Country Document Number Estimated Expiration
Slovakia123699► Subscribe
China1058010► Subscribe
European Patent Office1179533► Subscribe
Peru67999► Subscribe
African Regional IP Organization (ARIPO)9901649► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Baxter
Queensland Health
AstraZeneca
McKinsey
Medtronic
Moodys
Novartis
Mallinckrodt
Federal Trade Commission

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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