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Last Updated: July 10, 2020

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DEXYCU KIT Drug Profile


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Which patents cover Dexycu Kit, and when can generic versions of Dexycu Kit launch?

Dexycu Kit is a drug marketed by Eyepoint Pharms and is included in one NDA. There are five patents protecting this drug.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in DEXYCU KIT is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.

US ANDA Litigation and Generic Entry Outlook for Dexycu Kit

A generic version of DEXYCU KIT was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983.

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Summary for DEXYCU KIT
International Patents:34
US Patents:5
Applicants:1
NDAs:1
Clinical Trials: 3
Formulation / Manufacturing:see details
DailyMed Link:DEXYCU KIT at DailyMed
Drug patent expirations by year for DEXYCU KIT
Recent Clinical Trials for DEXYCU KIT

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

SponsorPhase
MDbackline, LLCPhase 2
Ocular Therapeutix, Inc.Phase 4
Silverstein Eye CentersPhase 4

See all DEXYCU KIT clinical trials

US Patents and Regulatory Information for DEXYCU KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 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

Supplementary Protection Certificates for DEXYCU KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1581193 SPC/GB12/047 United Kingdom   Start Trial PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780 13C0012 France   Start Trial PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
McKesson
Colorcon
AstraZeneca
Johnson and Johnson

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