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Last Updated: November 30, 2024

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BESIVANCE Drug Patent Profile


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Which patents cover Besivance, and what generic alternatives are available?

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
Drug Prices for BESIVANCE

See drug prices for BESIVANCE

Drug Sales Revenue Trends for BESIVANCE

See drug sales revenues for BESIVANCE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Ocular Therapeutix, Inc.Phase 4
Sight Medical Doctors PLLCPhase 4
Rutgers, The State University of New JerseyPhase 1

See all BESIVANCE clinical trials

Pharmacology 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 ⤷  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

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

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

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.

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
South Korea 100701721 ⤷  Sign Up
Denmark 1165058 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.