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Last Updated: November 22, 2024

MAXIDEX Drug Patent Profile


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

Maxidex is a drug marketed by Alcon and Harrow Eye and is included in two NDAs.

The generic ingredient in MAXIDEX 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 Maxidex

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

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

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Recent Clinical Trials for MAXIDEX

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

SponsorPhase
Medical College of WisconsinPhase 2
Benha UniversityPhase 1
AbbViePhase 1

See all MAXIDEX clinical trials

Pharmacology for MAXIDEX

US Patents and Regulatory Information for MAXIDEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon MAXIDEX dexamethasone sodium phosphate OINTMENT;OPHTHALMIC 083342-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Harrow Eye MAXIDEX dexamethasone SUSPENSION/DROPS;OPHTHALMIC 013422-001 Approved Prior to Jan 1, 1982 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

EU/EMA Drug Approvals for MAXIDEX

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

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