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Besifloxacin hydrochloride - Generic Drug Details

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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-two patent family members in twenty countries.

There is one drug master file entry for besifloxacin hydrochloride. 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: see list1
Suppliers / Packaging: see list2

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, 2009RXYes6,685,958<disabled>Y <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, 2009RXYes8,937,062<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: besifloxacin hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 20095,447,926<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
5,385,900 Quinoline carboxylic acid derivatives<disabled in preview>
7,749,970Topical treatment of prevention of ocular infections<disabled in preview>
7,056,893Topical treatment for prevention of ocular infections<disabled in preview>
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International Patent Family for Ingredient: besifloxacin hydrochloride

Country Document Number Estimated Expiration
Japan2002540147<disabled in preview>
World Intellectual Property Organization (WIPO)02100309<disabled in preview>
Germany1165058<disabled in preview>
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