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Last Updated: June 29, 2022

DEXTENZA Drug Patent Profile


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Which patents cover Dextenza, and when can generic versions of Dextenza launch?

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

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

The generic ingredient in DEXTENZA 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 Dextenza

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

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

See drug prices for DEXTENZA

Recent Clinical Trials for DEXTENZA

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

SponsorPhase
Grene Vision GroupPhase 4
Brian Jerkins, MDPhase 4
Massachusetts Eye and Ear InfirmaryPhase 4

See all DEXTENZA clinical trials

Pharmacology for DEXTENZA
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 three US patents and two FDA Regulatory Exclusivities.

Patents protecting DEXTENZA

Drug delivery through hydrogel plugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Drug delivery through hydrogel plugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: DEXTENZA IS APPROVED FOR THE TREATMENT OF OCULAR PAIN FOLLOWING OPHTHALMIC SURGERY

Composite hydrogel drug delivery systems
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DEXTENZA

TREATMENT OF OCULAR INFLAMMATION FOLLOWING OPHTHALMIC SURGERY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Ocular Therapeutix DEXTENZA dexamethasone INSERT;OPHTHALMIC 208742-001 Nov 30, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
Laboratoires CTRS  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 DEXTENZA

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

Country Patent Number Title Estimated Expiration
European Patent Office 3153194 BIOMATÉRIAUX POUR FERMETURE DE PERFORATION ET DE VOIE (BIOMATERIALS FOR TRACK AND PUNCTURE CLOSURE) See Plans and Pricing
Japan 5684239 See Plans and Pricing
Japan 2012525925 See Plans and Pricing
Japan 5890182 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010129510 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DEXTENZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780 13C0012 France See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Colorcon
Moodys
Harvard Business School
Boehringer Ingelheim

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