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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
Drug Prices: :see details

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, 2009RXYes5,447,926Apr 13, 2016YY
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,604,020Mar 12, 2030Y
Bausch And Lomb
BESIVANCE
besifloxacin hydrochloride
SUSPENSION/DROPS;OPHTHALMIC022308-001May 28, 2009RXYes8,415,342Nov 7, 2030
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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>
7,056,893Topical treatment for 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
Taiwan201038536<disabled in preview>
Mexico2009009657<disabled in preview>
Canada2065846<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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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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