DEXTENZA Drug Patent Profile

When do Dextenza patents expire, and when can generic versions of Dextenza launch?

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

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dextenza

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

Summary for DEXTENZA

International Patents:	26
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	45
Patent Applications:	4,555
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DEXTENZA
What excipients (inactive ingredients) are in DEXTENZA?	DEXTENZA excipients list
DailyMed Link:	DEXTENZA at DailyMed

See drug prices for DEXTENZA

Recent Clinical Trials for DEXTENZA

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

Sponsor	Phase
Wyse Eyecare	Phase 4
Duke University	Early Phase 1
Navy Medical Center San Diego	Phase 4

See all DEXTENZA clinical trials

Pharmacology for DEXTENZA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for DEXTENZA

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 DEXTENZA

DEXTENZA is protected by five US patents and one FDA Regulatory Exclusivity.

Patents protecting DEXTENZA

FDA Regulatory Exclusivity protecting 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
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes			Y
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes
Ocular Therapeutix	DEXTENZA	dexamethasone	INSERT;OPHTHALMIC	208742-001	Nov 30, 2018		RX	Yes	Yes

EU/EMA Drug Approvals for DEXTENZA

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

International Patents for DEXTENZA

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

Country	Patent Number	Title	Estimated Expiration
Canada	2760704	BIOMATERIAUX POUR LA FERMETURE DE VOIE ET DE PONCTION (BIOMATERIALS FOR TRACK AND PUNCTURE CLOSURE)
World Intellectual Property Organization (WIPO)	2010093873
Japan	2003523926
Australia	5486399

Supplementary Protection Certificates for DEXTENZA

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	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	SPC/GB12/058	United Kingdom		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