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Last Updated: March 28, 2024

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FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE Drug Patent Profile


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When do Fluorescein Sodium And Benoxinate Hydrochloride patents expire, and what generic alternatives are available?

Fluorescein Sodium And Benoxinate Hydrochloride is a drug marketed by Bausch Lomb Ireland and is included in one NDA. There are three patents protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is benoxinate hydrochloride; fluorescein sodium. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the benoxinate hydrochloride; fluorescein sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Fluorescein Sodium And Benoxinate Hydrochloride

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
International Patents:4
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 3
Clinical Trials: 1
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE excipients list
DailyMed Link:FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
Generic Entry Date for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION/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 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

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

SponsorPhase
Centre de recherche du Centre hospitalier universitaire de SherbrookeN/A

See all FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE clinical trials

Pharmacology for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE
Drug ClassDiagnostic Dye
Mechanism of ActionDyes
Anatomical Therapeutic Chemical (ATC) Classes for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

US Patents and Regulatory Information for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Fluorescein and benoxinate compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC

Fluorescein and benoxinate compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC

Fluorescein and benoxinate compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: PROCEDURES IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

When does loss-of-exclusivity occur for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?

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

Canada

Patent: 82603
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1565761
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 10069
Estimated Expiration: ⤷  Try a Trial

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 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3710069 COMPOSITIONS DE FLUORESCÉINE ET DE BÉNOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS) ⤷  Try a Trial
China 111565761 荧光素和丁氧普鲁卡因组合物 (FLUORESCEIN AND BENOXINATE COMPOSITIONS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019099739 ⤷  Try a Trial
Canada 3082603 COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS) ⤷  Try a Trial
>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.