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Last Updated: July 13, 2020

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OZURDEX Drug Profile


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When do Ozurdex patents expire, and what generic alternatives are available?

Ozurdex is a drug marketed by Allergan and is included in one NDA. There are sixteen patents protecting this drug.

This drug has one hundred and fifty-eight patent family members in twenty-seven countries.

The generic ingredient in OZURDEX 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 Ozurdex

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

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Drug patent expirations by year for OZURDEX
Drug Prices for OZURDEX

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Recent Clinical Trials for OZURDEX

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SponsorPhase
Medical College of WisconsinPhase 1
Yeungnam University College of MedicinePhase 4
Hospices Civils de LyonPhase 2

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Pharmacology for OZURDEX

US Patents and Regulatory Information for OZURDEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 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 OZURDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1581193 122012000081 Germany   Start Trial PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: 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
1581193 SPC/GB12/047 United Kingdom   Start Trial PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
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 C300552 Netherlands   Start Trial PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Colorcon

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