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Last Updated: March 28, 2024

BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM - Generic Drug Details


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What are the generic drug sources for benoxinate hydrochloride; fluorescein sodium and what is the scope of patent protection?

Benoxinate hydrochloride; fluorescein sodium is the generic ingredient in two branded drugs marketed by Altaire Pharms Inc and Bausch Lomb Ireland, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benoxinate hydrochloride; fluorescein sodium has four patent family members in four countries.

Four suppliers are listed for this compound.

Summary for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
International Patents:4
US Patents:3
Tradenames:2
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 4
Clinical Trials: 1
DailyMed Link:BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Generic Entry Date for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM*:
Constraining patent/regulatory exclusivity:
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 BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

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

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

See all BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM clinical trials

Pharmacology for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM
Drug ClassDiagnostic Dye
Mechanism of ActionDyes

US Patents and Regulatory Information for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

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 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 ⤷  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
Altaire Pharms Inc ALTAFLUOR BENOX benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 208582-001 Dec 14, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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 BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

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.