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Last Updated: March 19, 2024

Dexamethasone - Generic Drug Details


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What are the generic sources for dexamethasone and what is the scope of freedom to operate?

Dexamethasone is the generic ingredient in thirty-four branded drugs marketed by Allergan Herbert, Merck, Hikma, Alpharma Us Pharms, Anima, Chartwell Molecular, Lyne, Pharmobedient Cnsltg, Aspen Global Inc, Abbvie, Ocular Therapeutix, Watson Labs, Harrow Eye, Eyepoint Pharms, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Impax Labs, Larken Labs Inc, Novitium Pharma, Pangea, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Zydus Pharms, Solvay, Dexcel, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Bel Mar, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Geneyork Pharms, Gland Pharma Ltd, Intl Medication, Luitpold, Lyphomed, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, West-ward Pharms Int, Wyeth Ayerst, Pharmafair, Alcon, Sola Barnes Hind, Bausch And Lomb, Sandoz, Alcon Pharms Ltd, Novartis, and Padagis Us, and is included in one hundred and forty-seven NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has seventy-one patent family members in twenty countries.

There are thirty-nine drug master file entries for dexamethasone. Forty suppliers are listed for this compound.

Summary for dexamethasone
Drug Prices for dexamethasone

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Drug Sales Revenue Trends for dexamethasone

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Recent Clinical Trials for dexamethasone

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

SponsorPhase
Carl Ola Landgren, MD, PhDPhase 2
Dipenkumar ModiPhase 2
National Trauma CenterN/A

See all dexamethasone clinical trials

Pharmacology for dexamethasone
Medical Subject Heading (MeSH) Categories for dexamethasone

US Patents and Regulatory Information for dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novitium Pharma DEXAMETHASONE dexamethasone TABLET;ORAL 215604-005 Oct 5, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms DEXAMETHASONE dexamethasone TABLET;ORAL 216283-001 Feb 7, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck DECADRON dexamethasone sodium phosphate INJECTABLE;INJECTION 012071-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Solvay DEXONE 0.75 dexamethasone TABLET;ORAL 084993-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 084493-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aspen Global Inc HEXADROL dexamethasone TABLET;ORAL 012675-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 ⤷  Try a Trial ⤷  Try a Trial
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 ⤷  Try a Trial ⤷  Try a Trial
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
Abbvie OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for dexamethasone

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

International Patents for dexamethasone

Country Patent Number Title Estimated Expiration
Israel 276048 מערכות, ערכות ושיטות להעמסה והעברה של כמות קטנה של מינון ממזרק (Systems, kits and methods for loading and delivering a small volume dose from a syringe) ⤷  Try a Trial
European Patent Office 3003318 UTILISATION DE LA DÉXAMÉTHASONE À LIBÉRATION PROLONGÉE DANS UNE INFLAMMATION APRÈS UNE CHIRURGIE DE LA CATARACTE (USE OF SUSTAINED RELEASE DEXAMETHASONE IN POST-CATARACT SURGERY INFLAMMATION) ⤷  Try a Trial
Serbia 58825 VOĐICE ZA DOZIRANJE ZA INJEKCIONI ŠPRIC (DOSE GUIDES FOR INJECTION SYRINGE) ⤷  Try a Trial
South Korea 20160040471 백내장 수술 후 염증에서의 서방출 덱사메타손의 용도 (USE OF SUSTAINED RELEASE DEXAMETHASONE IN POST-CATARACT SURGERY INFLAMMATION) ⤷  Try a Trial
European Patent Office 2701773 GUIDES DE DOSE POUR SERINGUE D'INJECTION (DOSE GUIDES FOR INJECTION SYRINGE) ⤷  Try a Trial
Denmark 2701773 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dexamethasone

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

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