BESIVANCE Drug Patent Profile

Which patents cover Besivance, and when can generic versions of Besivance launch?

Besivance is a drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in BESIVANCE is besifloxacin hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the besifloxacin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Besivance

Besivance was eligible for patent challenges on May 28, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 9, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for BESIVANCE

International Patents:	24
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	13
Patent Applications:	28
Drug Prices:	Drug price information for BESIVANCE
Drug Sales Revenues:	Drug sales revenues for BESIVANCE
What excipients (inactive ingredients) are in BESIVANCE?	BESIVANCE excipients list
DailyMed Link:	BESIVANCE at DailyMed

See drug prices for BESIVANCE

See drug sales revenues for BESIVANCE

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

NDA:

022308

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 BESIVANCE

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

Sponsor	Phase
Ocular Therapeutix, Inc.	Phase 4
Sight Medical Doctors PLLC	Phase 4
Rutgers, The State University of New Jersey	Phase 1

See all BESIVANCE clinical trials

Pharmacology for BESIVANCE

Drug Class

Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for BESIVANCE

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BESIVANCE

BESIVANCE is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BESIVANCE

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

Expired US Patents for BESIVANCE

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
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009

International Patents for BESIVANCE

When does loss-of-exclusivity occur for BESIVANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

European Patent Office

Japan

Mexico

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BESIVANCE around the world.

Country	Patent Number	Title	Estimated Expiration
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)
Japan	H08169880	QUINOLONE CARBOXYLIC ACID DERIVATIVE
Japan	2805460
Canada	2756769	CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)