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Last Updated: August 14, 2020

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Fluorescein sodium - Generic Drug Details

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

Fluorescein sodium is the generic ingredient in four branded drugs marketed by Novartis, Akorn, and Alcon Labs Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for fluorescein sodium. Three suppliers are listed for this compound.

Summary for fluorescein sodium
Recent Clinical Trials for fluorescein sodium

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

Mayo ClinicPhase 2
UpTru Inc.Phase 1
Medicor Research Inc.Phase 1

See all fluorescein sodium clinical trials

Pharmacology for fluorescein sodium
Drug ClassDiagnostic Dye
Mechanism of ActionDyes
Medical Subject Heading (MeSH) Categories for fluorescein sodium

US Patents and Regulatory Information for fluorescein sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-001 Aug 8, 2008 AP RX Yes No   Start Trial   Start Trial   Start Trial
Akorn AK-FLUOR 25% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-002 Aug 8, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis FUNDUSCEIN-25 fluorescein sodium INJECTABLE;INJECTION 017869-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Alcon Labs Inc FLUORESCITE fluorescein sodium INJECTABLE;INTRAVENOUS 021980-001 Mar 28, 2006 AP RX Yes Yes   Start Trial   Start Trial   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:

Express Scripts
Johnson and Johnson
Harvard Business School

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