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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Summary for FLUORESCEIN SODIUM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Clinical Trials:	44
Patent Applications:	703
Formulation / Manufacturing:	see details
DailyMed Link:	FLUORESCEIN SODIUM at DailyMed

Drug patent expirations by year for FLUORESCEIN SODIUM

Recent Clinical Trials for FLUORESCEIN SODIUM

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

Sponsor	Phase
Stanford University	Phase 2
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Early Phase 1
Seoul National University Bundang Hospital	Phase 4

See all FLUORESCEIN SODIUM clinical trials

Pharmacology for FLUORESCEIN SODIUM

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

Medical Subject Heading (MeSH) Categories for FLUORESCEIN SODIUM

Contrast Media
Fluorescent Dyes

Anatomical Therapeutic Chemical (ATC) Classes for FLUORESCEIN SODIUM

S01JA	Colouring agents
S01J	DIAGNOSTIC AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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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