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Last Updated: November 4, 2024

DEXAMETHASONE INTENSOL Drug Patent Profile


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

Dexamethasone Intensol is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DEXAMETHASONE INTENSOL 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 Dexamethasone Intensol

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

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Drug patent expirations by year for DEXAMETHASONE INTENSOL
Drug Prices for DEXAMETHASONE INTENSOL

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Recent Clinical Trials for DEXAMETHASONE INTENSOL

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

SponsorPhase
Mayo ClinicPhase 1
Southwest Oncology GroupPhase 3
University of Southern CaliforniaPhase 1/Phase 2

See all DEXAMETHASONE INTENSOL clinical trials

Pharmacology for DEXAMETHASONE INTENSOL

US Patents and Regulatory Information for DEXAMETHASONE INTENSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DEXAMETHASONE INTENSOL dexamethasone CONCENTRATE;ORAL 088252-001 Sep 1, 1983 RX No 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 DEXAMETHASONE INTENSOL

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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