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Last Updated: June 13, 2021

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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 eight patents protecting this drug.

This drug has one hundred and forty 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. Thirty 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 XSPIRE PHARMA on April 28th, 1983.

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

See drug prices for OZURDEX

Recent Clinical Trials for OZURDEX

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

SponsorPhase
He Eye HospitalN/A
Medical College of WisconsinPhase 1
Yeungnam University College of MedicinePhase 4

See all OZURDEX clinical trials

Pharmacology for OZURDEX
ATC Classes for OZURDEX
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AB Corticosteroids, moderately potent (group II)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XB Corticosteroids, moderately potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

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   Get Started Free   Get Started Free Y   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009   Get Started Free   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009   Get Started Free   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009   Get Started Free   Get Started Free
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for OZURDEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 13C0012 France   Get Started Free 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   Get Started Free PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1429780 SPC/GB12/058 United Kingdom   Get Started Free 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   Get Started Free PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Colorcon

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