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Last Updated: November 22, 2024

OZURDEX Drug Patent Profile


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

Ozurdex is a drug marketed by Abbvie and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Ozurdex

A generic version of OZURDEX was approved as dexamethasone by HIKMA on September 15th, 1983.

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Summary for OZURDEX
Drug patent expirations by year for OZURDEX
Drug Prices for OZURDEX

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Recent Clinical Trials for OZURDEX

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

SponsorPhase
Oxular LimitedPhase 2
Hospital for Special Surgery, New YorkPhase 4
Karyopharm Therapeutics IncPhase 2

See all OZURDEX clinical trials

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
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OZURDEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for OZURDEX

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH & Co. KG Ozurdex dexamethasone EMEA/H/C/001140
Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy.
Authorised no no no 2010-07-26
THERAVIA Neofordex dexamethasone EMEA/H/C/004071
Treatment of multiple myeloma.
Authorised no no no 2016-03-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for OZURDEX

See the table below for patents covering OZURDEX around the world.

Country Patent Number Title Estimated Expiration
Norway 325505 ⤷  Sign Up
Hungary E044694 ⤷  Sign Up
Taiwan 200635565 Improved apparatus for delivery of ocular implants ⤷  Sign Up
European Patent Office 1296645 PROCEDES SERVANT A TRAITER DES ETATS INFLAMMATOIRES DE L'OEIL (METHODS FOR TREATING INFLAMMATION-MEDIATED CONDITIONS OF THE EYE) ⤷  Sign Up
Japan 2006525953 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OZURDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom ⤷  Sign Up 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
1429780 13C0012 France ⤷  Sign Up 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 122012000081 Germany ⤷  Sign Up PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1581193 C300552 Netherlands ⤷  Sign Up PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1581193 SPC/GB12/047 United Kingdom ⤷  Sign Up PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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