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Last Updated: November 22, 2024

FLUORESCEIN SODIUM Drug Patent Profile


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

Fluorescein Sodium is a drug marketed by Nexus Pharms and Bausch Lomb Ireland and is included in two NDAs. There are three patents protecting this drug.

The generic ingredient in FLUORESCEIN SODIUM 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

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Drug patent expirations by year for FLUORESCEIN SODIUM
Recent Clinical Trials for FLUORESCEIN SODIUM

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

SponsorPhase
Stanford UniversityPhase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolEarly Phase 1
Seoul National University Bundang HospitalPhase 4

See all FLUORESCEIN SODIUM clinical trials

Pharmacology for FLUORESCEIN SODIUM
Drug ClassDiagnostic Dye
Mechanism of ActionDyes
Medical Subject Heading (MeSH) Categories for FLUORESCEIN SODIUM
Anatomical Therapeutic Chemical (ATC) Classes for FLUORESCEIN SODIUM

US Patents and Regulatory Information for FLUORESCEIN SODIUM

FLUORESCEIN SODIUM is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting FLUORESCEIN SODIUM

COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nexus Pharms FLUORESCEIN SODIUM fluorescein sodium INJECTABLE;INTRAVENOUS 215709-001 Sep 25, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Nexus Pharms FLUORESCEIN SODIUM fluorescein sodium INJECTABLE;INTRAVENOUS 215709-002 Sep 25, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch Lomb Ireland FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE benoxinate hydrochloride; fluorescein sodium SOLUTION/DROPS;OPHTHALMIC 211039-001 Mar 9, 2020 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

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