BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM - Generic Drug Details

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

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

Sponsor	Phase
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	N/A

See all BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM clinical trials

Pharmacology for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

Anatomical Therapeutic Chemical (ATC) Classes for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

S01JA	Colouring agents
S01J	DIAGNOSTIC AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes			Y
Altaire Pharms Inc	ALTAFLUOR BENOX	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	208582-001	Dec 14, 2017		RX	Yes	Yes
Bausch Lomb Ireland	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE	benoxinate hydrochloride; fluorescein sodium	SOLUTION/DROPS;OPHTHALMIC	211039-001	Mar 9, 2020		RX	Yes	Yes			Y

International Patents for BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM

Country	Patent Number	Title	Estimated Expiration
China	111565761	荧光素和丁氧普鲁卡因组合物 (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
European Patent Office	3710069	COMPOSITIONS DE FLUORESCÉINE ET DE BÉNOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
Canada	3082603	COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2019099739