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BESIVANCE Drug Patent Profile

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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

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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:	17
Drug Prices:	Drug price information for BESIVANCE
What excipients (inactive ingredients) are in BESIVANCE?	BESIVANCE excipients list
DailyMed Link:	BESIVANCE at DailyMed

Drug patent expirations by year for BESIVANCE

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

Generic Entry Date for BESIVANCE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Sight Medical Doctors PLLC	Phase 4
Ocular Therapeutix, Inc.	Phase 4
Rutgers, The State University of New Jersey	Phase 1

See all BESIVANCE clinical trials

Pharmacology for BESIVANCE

Drug Class	Quinolone Antimicrobial

US Patents and Regulatory Information for BESIVANCE

BESIVANCE is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BESIVANCE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Besifloxacin ophthalmic composition for the treatment or control of infection
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

Fluoroquinolone carboxylic acid molecular crystals
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions and methods for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

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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				⤷ 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
>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 BESIVANCE

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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 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

Patent: 5926
Patent: CRISTALES MOLECULARES DE ACIDO CARBOXILICO DE FLUOROQUINOLONA
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 1009849
Patent: forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 56769
Patent: CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 2369189
Patent: Fluoroquinolone carboxylic acid molecular crystals
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 11369
Patent: CRISTAUX MOLÉCULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 12521433
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 11009758
Patent: CRISTALES MOLECULARES DE FLUOROQUINOLONA ACIDO CARBOXILICO. (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS.)
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 110122202
Patent: FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 68394
Estimated Expiration: ⤷ Sign Up

Patent: 1038536
Patent: Fluoroquinolone carboxylic acid molecular crystals
Estimated Expiration: ⤷ Sign Up

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.

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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)	⤷ Sign Up
Japan	H08169880	QUINOLONE CARBOXYLIC ACID DERIVATIVE	⤷ Sign Up
Japan	2805460		⤷ Sign Up
Canada	2756769	CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)	⤷ Sign Up
Austria	296093		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration