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Serving leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Johnson and Johnson
AstraZeneca
Merck
UBS
Cipla
Mallinckrodt
Healthtrust
QuintilesIMS

Generated: November 19, 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 ninety-one patent family members in forty countries.

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

Pharmacology for 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► Subscribe ► 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► 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
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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
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
7,595,328Methods of use of quinolone compounds against pneumococcal and Haemophilus bacteria► Subscribe
5,633,262 Quinoline carboxylic acid derivatives having 7-(4-amino-methyl-3-oxime) pyrrolidine substituent and processes for preparing thereof► 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
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
6,938,154 System, method and article of manufacture for a cryptographic key infrastructure for networked devices► Subscribe
6,659,418 Positioning & locking hanging system► Subscribe
5,840,916 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
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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
Austria239724► Subscribe
Canada2282066► Subscribe
Spain2213669► Subscribe
Bulgaria103750► Subscribe
Slovenia1179533► Subscribe
Saudi Arabia1397► Subscribe
Argentina012125► Subscribe
Hong Kong1026698► Subscribe
JapanH0841050► Subscribe
Germany69821147► 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 leading biopharmaceutical companies globally:

US Department of Justice
Cipla
Fish and Richardson
Fuji
UBS
Express Scripts
Harvard Business School
Cantor Fitzgerald
Dow
Healthtrust

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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