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Serving 500+ biopharmaceutical companies globally:

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Generated: September 24, 2017

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Gemifloxacin mesylate - Generic Drug Details

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What are the generic sources for gemifloxacin mesylate and what is the scope of gemifloxacin mesylate freedom to operate?

Gemifloxacin mesylate
is the generic ingredient in two branded drugs marketed by Lg Chem Ltd and Orchid Hlthcare, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Gemifloxacin mesylate has eighty-four patent family members in forty countries.

There are two drug master file entries for gemifloxacin mesylate. Two suppliers are listed for this compound.

Summary for Generic Name: gemifloxacin mesylate

Tradenames:2
Patents:7
Applicants:2
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list42
Clinical Trials: see list520
Patent Applications: see list216
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gemifloxacin mesylate at DailyMed

Pharmacology for Ingredient: gemifloxacin mesylate

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, 2003ABRXYesYes► Subscribe► Subscribe ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► Subscribe ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► Subscribe ► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Orchid Hlthcare
GEMIFLOXACIN MESYLATE
gemifloxacin mesylate
TABLET;ORAL090466-001Jun 15, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Lg Chem Ltd
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003ABRXYesYes► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gemifloxacin mesylate

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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Non-Orange Book Patents for Generic Ingredient: gemifloxacin mesylate

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
7,700,617Salt of naphthyridine carboxylic acid derivative► 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
5,698,570 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime)pyrrolidine substituent and processes for preparing thereof► Subscribe
7,595,328Methods of use of quinolone compounds against pneumococcal and Haemophilus bacteria► Subscribe
6,659,418 Positioning & locking hanging system► Subscribe
6,938,154 System, method and article of manufacture for a cryptographic key infrastructure for networked devices► Subscribe
5,633,262 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
5,962,468 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
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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 Ingredient: gemifloxacin mesylate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0100209► Subscribe
Argentina012125► Subscribe
Portugal1179533► Subscribe
Canada2283671► Subscribe
Spain2198697► Subscribe
Turkey9902313► Subscribe
Spain2213669► Subscribe
United Kingdom9915597► Subscribe
Japan2003531101► Subscribe
Japan4781614► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
Cerilliant
Mallinckrodt
Baxter
Daiichi Sankyo
QuintilesIMS
Argus Health
Farmers Insurance
Chubb
Harvard Business School

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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