BESIFLOXACIN HYDROCHLORIDE - Generic Drug Details

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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.

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

International Patents:	24
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	17
Patent Applications:	41
DailyMed Link:	BESIFLOXACIN HYDROCHLORIDE at DailyMed

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

Generic Entry Date for BESIFLOXACIN HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	⤷ Sign Up	⤷ Sign Up
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009	⤷ Sign Up	⤷ Sign Up
>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
Argentina	075926	CRISTALES MOLECULARES DE ACIDO CARBOXILICO DE FLUOROQUINOLONA	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2010111116		⤷ Sign Up
China	102369189	Fluoroquinolone carboxylic acid molecular crystals	⤷ Sign Up
South Korea	20130010131	FLUOROQUINOLONES FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA	⤷ Sign Up
Brazil	PI1009849	forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.	⤷ Sign Up
European Patent Office	2136812	FLUOROQUINOLONES POUR TRAITER, RÉDUIRE, AMÉLIORER OU PRÉVENIR DES INFECTIONS CAUSÉES PAR DES BACTÉRIES RÉSISTANTES AUX MÉDICAMENTS ANTIBACTÉRIENS (COMPOSITIONS AND METHODS FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008115951		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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