Last Updated: November 5, 2026

BESIFLOXACIN HYDROCHLORIDE - Generic Drug Details

Name: BESIFLOXACIN HYDROCHLORIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic drug sources for besifloxacin hydrochloride and what is the scope of patent protection?

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.

Three suppliers are listed for this compound.

Summary for BESIFLOXACIN HYDROCHLORIDE

International Patents:	24
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BESIFLOXACIN HYDROCHLORIDE
DailyMed Link:	BESIFLOXACIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BESIFLOXACIN HYDROCHLORIDE

Generic Entry Date for BESIFLOXACIN HYDROCHLORIDE^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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

Sponsor	Phase
Instituto de Oftalmología Fundación Conde de Valenciana	Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A
McGill University Health Center	N/A

See all BESIFLOXACIN HYDROCHLORIDE clinical trials

Pharmacology for BESIFLOXACIN HYDROCHLORIDE

Drug Class	Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for BESIFLOXACIN HYDROCHLORIDE

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BESIFLOXACIN HYDROCHLORIDE

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Glossary

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial		Y		⤷ Start Trial
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start 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

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

International Patents for BESIFLOXACIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010051291		⤷ Start Trial
Argentina	075926	CRISTALES MOLECULARES DE ACIDO CARBOXILICO DE FLUOROQUINOLONA	⤷ Start Trial
Brazil	PI1009849	forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.	⤷ Start Trial
Canada	2756769	CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)	⤷ Start Trial
China	102369189	Fluoroquinolone carboxylic acid molecular crystals	⤷ Start Trial
European Patent Office	2411369	CRISTAUX MOLÉCULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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