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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Fish and Richardson
Accenture
US Department of Justice
QuintilesIMS
Mallinckrodt
Baxter
Citi
Cantor Fitzgerald
US Army

Generated: January 16, 2018

DrugPatentWatch Database Preview

FACTIVE Drug Profile

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When do Factive patents expire, and what generic 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 ninety-one 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 FACTIVE
Drug patent expirations by year for FACTIVE
Pharmacology for FACTIVE
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

US Patents and Regulatory Information for FACTIVE

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;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for FACTIVE

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

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Paragraph IV (Patent) Challenges for FACTIVE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 320 mg ➤ Subscribe 3/4/2008

Non-Orange Book US Patents for 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
5,633,262 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime) pyrrolidine substituent and processes for preparing thereof ➤ Subscribe
7,700,617 Salt of naphthyridine carboxylic acid derivative ➤ Subscribe
6,938,154 System, method and article of manufacture for a cryptographic key infrastructure for networked devices ➤ Subscribe
5,698,570 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime)pyrrolidine substituent and processes for preparing thereof ➤ Subscribe
6,279,257 Flush mounting security frames and hardware ➤ Subscribe
5,869,670 7-(4-aminomethyl-3-me thyloxyiminopyrrolidin-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
5,840,916 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime) pyrrolidine substituent and processes for preparing thereof ➤ Subscribe
6,659,418 Positioning & locking hanging system ➤ Subscribe
7,595,328 Methods of use of quinolone compounds against pneumococcal and Haemophilus bacteria ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for FACTIVE

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Serving leading biopharmaceutical companies globally:

Fuji
AstraZeneca
US Department of Justice
Mallinckrodt
Deloitte
Farmers Insurance
Covington
Novartis
Accenture

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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