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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, 2009RXYes8,481,526<disabled>Y<disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes5,447,926<disabled>YY<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, 2009RXYes8,604,020<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
7,749,970Topical treatment of prevention of ocular infections<disabled in preview>
5,385,900 Quinoline carboxylic acid derivatives<disabled in preview>
6,569,443 Topical treatment or prevention of ocular infections<disabled in preview>
7,056,893Topical treatment for 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
Austria296093Jun 15, 2005
European Patent Office1165058May 25, 2005
Argentina075926May 04, 2011
Denmark0493608Feb 19, 1996
China102369189Mar 07, 2012
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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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