OZURDEX Drug Patent Profile

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 seven patents protecting this drug.

This drug has one hundred and twenty-four 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-one 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 28^th, 1983.

Summary for OZURDEX

International Patents:	124
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	89
Patent Applications:	4,574
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OZURDEX
What excipients (inactive ingredients) are in OZURDEX?	OZURDEX excipients list
DailyMed Link:	OZURDEX at DailyMed

See drug prices for OZURDEX

Recent Clinical Trials for OZURDEX

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

Sponsor	Phase
Iworks Laser and Vision Center	Phase 4
Ocular Therapeutix, Inc.	Phase 4
Ottawa Hospital Research Institute	Phase 4

See all OZURDEX clinical trials

Pharmacology for OZURDEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (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

OZURDEX is protected by eleven US patents.

Patents protecting 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			Y
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009		RX	Yes	Yes
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009		RX	Yes	Yes

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
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009

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
Laboratoires CTRS	Neofordex	dexamethasone	EMEA/H/C/004071 Treatment of multiple myeloma.	Authorised	no	no	no	2016-03-16

International Patents for OZURDEX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1339438
Taiwan	200635565	Improved apparatus for delivery of ocular implants
Japan	2004501954

Supplementary Protection Certificates for OZURDEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		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		PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727