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Details for Generic Name: besifloxacin hydrochloride

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Besifloxacin hydrochloride is the generic ingredient in one branded drug marketed by Bausch And Lomb and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-one patent family members in nineteen countries.

Two suppliers are listed for this compound.

Summary for Generic Name: besifloxacin hydrochloride

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list3

Pharmacology for Ingredient: besifloxacin hydrochloride

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: besifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,415,342<disabled><disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes6,685,958<disabled>Y<disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,937,062<disabled><disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes6,699,492<disabled>Y<disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,481,526<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: besifloxacin hydrochloride

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
7,056,893Topical treatment for prevention of ocular infections<disabled in preview>
5,385,900 Quinoline carboxylic acid derivatives<disabled in preview>
7,732,415Topical treatment or prevention of ocular infections<disabled in preview>
6,569,443 Topical treatment or prevention of ocular infections<disabled in preview>
6,239,113 Topical treatment or prevention of ocular infections<disabled in preview>
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International Patent Family for Ingredient: besifloxacin hydrochloride

Country Document Number Publication Date
Germany1165058Oct 02, 2002
Hong Kong1063721Jun 20, 2014
Japan2613139May 21, 1997
Cyprus1107259Nov 21, 2012
Portugal1165058Oct 31, 2005
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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