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BESIVANCE Drug Profile

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Besivance is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug.

This drug has sixty-two patent family members in twenty countries.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.

Summary for Tradename: BESIVANCE

Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: BESIVANCE

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: BESIVANCE

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, 2009RXYes5,447,926<disabled>YY <disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,604,020<disabled>Y <disabled>
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,415,342<disabled> <disabled>
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Expired Patents for Tradename: BESIVANCE

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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 Tradename: BESIVANCE

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>
7,732,415Topical treatment or prevention of ocular infections<disabled in preview>
6,569,443 Topical treatment or prevention of ocular infections<disabled in preview>
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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 Tradename: BESIVANCE

Country Document Number Estimated Expiration
Spain2427596<disabled in preview>
Austria296093<disabled in preview>
World Intellectual Property Organization (WIPO)02100309<disabled in preview>
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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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