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Profile for Tradename: BESIVANCE

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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-one patent family members in nineteen countries.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. 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 list3

Pharmacology for Tradename: BESIVANCE

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: BESIVANCE

Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Status: Completed Condition: Congenital Nasolacrimal Duct Obstruction

Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Status: Completed Condition: Bacterial Conjunctivitis

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation
Status: Completed Condition: Healthy

2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Status: Completed Condition: Corneal Health; Cataract Surgery

Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Status: Terminated Condition: Bacterial Conjunctivitis

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Status: Completed Condition: Cataract Extraction

Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification
Status: Recruiting Condition: Cataracts

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Status: Terminated Condition: Bacterial Conjunctivitis

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis
Status: Completed Condition: Bacterial Conjunctivitis

Besifloxacin in Bacterial Keratitis
Status: Not yet recruiting Condition: Bacterial Keratitis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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>
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>
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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
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 Tradename: BESIVANCE

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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