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Last Updated: March 19, 2024

Besifloxacin hydrochloride - Generic Drug Details


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What are the generic sources for besifloxacin hydrochloride and what is the scope of freedom to operate?

Besifloxacin hydrochloride is the generic ingredient in one branded drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Besifloxacin hydrochloride has twenty-four patent family members in thirteen countries.

There are four drug master file entries for besifloxacin hydrochloride. Two suppliers are listed for this compound.

Summary for besifloxacin hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for besifloxacin hydrochloride
Generic Entry Date for besifloxacin hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for besifloxacin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Instituto de Oftalmología Fundación Conde de ValencianaPhase 1
McGill University Health Centre/Research Institute of the McGill University Health CentreN/A
McGill University Health CenterN/A

See all besifloxacin hydrochloride clinical trials

Pharmacology for besifloxacin hydrochloride

US Patents and Regulatory Information for besifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for besifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for besifloxacin hydrochloride

Country Patent Number Title Estimated Expiration
Mexico 2009009657 FLUOROQUINOLONAS PARA EL TRATAMIENTO, REDUCCION, MEJORA, O PREVENCION DE LAS INFECCIONES PROVOCADAS POR LAS BACTERIAS RESISTENTES A LOS FARMACOS ANTIBACTERIANOS. (FLUOROQUINOLONES FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA.) ⤷  Try a Trial
South Korea 20110122202 FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS ⤷  Try a Trial
Japan 2012521433 ⤷  Try a Trial
European Patent Office 2411369 CRISTAUX MOLÉCULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS) ⤷  Try a Trial
Mexico 2011009758 CRISTALES MOLECULARES DE FLUOROQUINOLONA ACIDO CARBOXILICO. (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS.) ⤷  Try a Trial
Spain 2427596 ⤷  Try a Trial
Canada 2679626 FLUOROQUINOLONES POUR TRAITER, REDUIRE, AMELIORER OU PREVENIR DES INFECTIONS CAUSEES PAR DES BACTERIES RESISTANTES AUX MEDICAMENTS ANTIBACTERIENS (FLUOROQUINOLONES FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL-DRUG RESISTANT BACTERIA) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.