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Gemifloxacin mesylate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for gemifloxacin mesylate?

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

Gemifloxacin mesylate has eighty-two patent family members in thirty-nine 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:8
Applicants:2
NDAs:2
Drug Master File Entries: see list2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list42
Clinical Trials: see list176
Patent Applications: see list215
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orchid Hlthcare
GEMIFLOXACIN MESYLATE
gemifloxacin mesylate
TABLET;ORAL090466-001Jun 15, 2015RXNoNo► Subscribe► Subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYesYes6,262,071► Subscribe ► Subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYesYes6,723,734► SubscribeYY ► Subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYesYes6,455,540► Subscribe ► Subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 2003RXYesYes6,331,550► 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 Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,633,262► Subscribe
Lg Life Sciences
FACTIVE
gemifloxacin mesylate
TABLET;ORAL021158-001Apr 4, 20035,962,468► 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
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
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
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
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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
South Korea100222082► Subscribe
United Kingdom9915597► Subscribe
Canada2281817► Subscribe
South Korea100266499► Subscribe
Spain2198697► 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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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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