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Last Updated: August 7, 2020

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DEXTENZA Drug Profile

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

Dextenza is a drug marketed by Ocular Therapeutix and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-five patent family members in six countries.

The generic ingredient in DEXTENZA 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 Dextenza

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

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Drug patent expirations by year for DEXTENZA
Drug Prices for DEXTENZA

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Recent Clinical Trials for DEXTENZA

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SponsorPhase
Ocular TherapeutixPhase 4
New England Retina AssociatesPhase 4
Eye Surgeons of IndianaPhase 4

See all DEXTENZA clinical trials

Pharmacology for DEXTENZA

US Patents and Regulatory Information for DEXTENZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 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 DEXTENZA

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:

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Boehringer Ingelheim

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