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Last Updated: November 4, 2024

HEXADROL Drug Patent Profile


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Which patents cover Hexadrol, and what generic alternatives are available?

Hexadrol is a drug marketed by Aspen Global Inc and is included in three NDAs.

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

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Summary for HEXADROL
Drug patent expirations by year for HEXADROL
Recent Clinical Trials for HEXADROL

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

SponsorPhase
Medical College of WisconsinPhase 2
Southwest Oncology GroupPhase 3
University of Southern CaliforniaPhase 1/Phase 2

See all HEXADROL clinical trials

US Patents and Regulatory Information for HEXADROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aspen Global Inc HEXADROL dexamethasone ELIXIR;ORAL 012674-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc HEXADROL dexamethasone TABLET;ORAL 012675-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc HEXADROL dexamethasone sodium phosphate INJECTABLE;INJECTION 014694-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc HEXADROL dexamethasone TABLET;ORAL 012675-010 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc HEXADROL dexamethasone sodium phosphate INJECTABLE;INJECTION 014694-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aspen Global Inc HEXADROL dexamethasone sodium phosphate INJECTABLE;INJECTION 014694-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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 HEXADROL

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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