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FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE Drug Patent Profile

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

Fluorescein Sodium And Benoxinate Hydrochloride is a drug marketed by Bausch Lomb Ireland and is included in one NDA. There are three patents protecting this drug.

This drug has four patent family members in four countries.

The generic ingredient in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE 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 And Benoxinate Hydrochloride

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 15, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

International Patents:	4
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
What excipients (inactive ingredients) are in FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE excipients list
DailyMed Link:	FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Generic Entry Date for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 211039 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 FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

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

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

See all FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE clinical trials

Pharmacology for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Drug Class	Diagnostic Dye
Mechanism of Action	Dyes

US Patents and Regulatory Information for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

Fluorescein and benoxinate compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: OCULAR EXAMINATION, INTRAOCULAR PRESSURE MEASUREMENT, OR REMOVAL OF FOREIGN BODIES OR SUTURES, IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC

Fluorescein and benoxinate compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROCEDURES IN ADULT AND PEDIATRIC PATIENTS REQUIRING A DISCLOSING AGENT IN COMBINATION WITH A TOPICAL OPHTHALMIC ANESTHETIC.

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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
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
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

International Patents for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE

When does loss-of-exclusivity occur for FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 82603
Patent: COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1565761
Patent: 荧光素和丁氧普鲁卡因组合物 (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 10069
Patent: COMPOSITIONS DE FLUORESCÉINE ET DE BÉNOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE around the world.

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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)	⤷ Sign Up
European Patent Office	3710069	COMPOSITIONS DE FLUORESCÉINE ET DE BÉNOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)	⤷ Sign Up
Canada	3082603	COMPOSITIONS DE FLUORESCEINE ET DE BENOXINATE (FLUORESCEIN AND BENOXINATE COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration