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Boehringer Ingelheim
Harvard Business School

Last Updated: December 7, 2021

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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. Four 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
University of Colorado, DenverN/A
Technische Universit√§t M√ľnchenPhase 2

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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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis FUNDUSCEIN-25 fluorescein sodium INJECTABLE;INJECTION 017869-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn AK-FLUOR 25% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-002 Aug 8, 2008 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn AK-FLUOR 10% fluorescein sodium INJECTABLE;INTRAVENOUS 022186-001 Aug 8, 2008 AP RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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