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Last Updated: September 25, 2022

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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Drug patent expirations by year for BESIVANCE
Drug Prices for BESIVANCE

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Drug Sales Revenue Trends for BESIVANCE

See drug sales revenues for BESIVANCE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BESIVANCE
Generic Entry Date for BESIVANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Sight Medical Doctors PLLCPhase 4
Ocular Therapeutix, Inc.Phase 4
Rutgers, The State University of New JerseyPhase 1

See all BESIVANCE clinical trials

Pharmacology for BESIVANCE
Anatomical Therapeutic Chemical (ATC) Classes for BESIVANCE

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS

Fluoroquinolone carboxylic acid molecular crystals
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fluoroquinolone carboxylic acid molecular crystals
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

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 See Plans and Pricing See Plans and Pricing
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 See Plans and Pricing See Plans and Pricing
Bausch And Lomb BESIVANCE besifloxacin hydrochloride SUSPENSION/DROPS;OPHTHALMIC 022308-001 May 28, 2009 See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1009849
Estimated Expiration: See Plans and Pricing

Canada

Patent: 56769
Estimated Expiration: See Plans and Pricing

China

Patent: 2369189
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 11369
Estimated Expiration: See Plans and Pricing

Japan

Patent: 12521433
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11009758
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 110122202
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 68394
Estimated Expiration: See Plans and Pricing

Patent: 1038536
Estimated Expiration: See Plans and Pricing

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
Canada 2756769 CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS) See Plans and Pricing
Canada 2445408 COMPOSITIONS D'ACIDE QUINOLONE CARBOXYLIQUE ET METHODES DE TRAITEMENT ASSOCIEES (QUINOLONE CARBOXYLIC ACID COMPOSITIONS AND RELATED METHODS OF TREATMENT) See Plans and Pricing
World Intellectual Property Organization (WIPO) 02100309 See Plans and Pricing
China 101641100 Fluoroquinolones for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria See Plans and Pricing
World Intellectual Property Organization (WIPO) 0057866 See Plans and Pricing
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.) See Plans and Pricing
Hong Kong 1041642 局部性治療或預防眼睛感染的氮雜內酯頪抗生素 (AZALIDE ANTIBIOTICS FOR THE TOPICAL TREATMENT OR PREVENTION OF OCULAR INFECTIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Harvard Business School
Medtronic
McKinsey
Mallinckrodt

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.