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Last Updated: April 19, 2021

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FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE Drug Profile

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Which patents cover Fluorescein Sodium And Benoxinate Hydrochloride, and when can generic versions of Fluorescein Sodium And Benoxinate Hydrochloride launch?

Fluorescein Sodium And Benoxinate Hydrochloride is a drug marketed by Bausch 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. Three 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
Suppliers / Packagers: 2
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 Generic Entry Opportunity 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

US Patents and Regulatory Information for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

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

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Merck
AstraZeneca
Express Scripts
Dow

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.