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Last Updated: December 1, 2022

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, Wockhardt Bio Ag, Aspen Global Inc, Allergan, Ocular Therapeutix, Watson Labs, Novartis, Eyepoint Pharms, Alvogen, Amneal, Bausch, Heritage Pharma, Impax Labs, Larken Labs Inc, Novitium Pharma, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Strides Pharma, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Xspire Pharma, Solvay, Dexcel Pharma, Watson Labs Teva, Ucb Inc, Cent Pharms, Abraxis Pharm, Fresenius Kabi Usa, Akorn, Bel Mar, Dell Labs, Dr Reddys, Eugia Pharma, 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 Inc, Alcon Pharms Ltd, Padagis Us, Imprimis Pharms Usa, and Eyevance, and is included in one hundred and thirty-eight NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has one hundred and ninety-four patent family members in thirty countries.

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

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
Acacia Pharma LtdPhase 2/Phase 3
Premier Research Group plcPhase 2/Phase 3
Amicus CD LLCPhase 2/Phase 3

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
Novartis TOBRADEX dexamethasone; tobramycin OINTMENT;OPHTHALMIC 050616-001 Sep 28, 1988 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Industries DEXAMETHASONE dexamethasone TABLET;ORAL 084013-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Parenteral DEXAMETHASONE SODIUM PHOSPHATE dexamethasone sodium phosphate INJECTABLE;INJECTION 081126-001 Aug 31, 1990 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Imprimis Pharms Usa MAXITROL dexamethasone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OPHTHALMIC 050023-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novitium Pharma DEXAMETHASONE dexamethasone TABLET;ORAL 215604-002 Aug 8, 2022 AB RX No No 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

Expired US Patents for dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 See Plans and Pricing See Plans and Pricing
Eyepoint Pharms DEXYCU KIT dexamethasone SUSPENSION;INTRAOCULAR 208912-001 Feb 9, 2018 See Plans and Pricing See Plans and Pricing
>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
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 dexamethasone

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0009088 See Plans and Pricing
Australia 2016228285 Ocular implant made by a double extrusion process See Plans and Pricing
Japan 2014521372 See Plans and Pricing
Croatia P20190828 See Plans and Pricing
Turkey 201802793 See Plans and Pricing
Australia 2003272575 METHODS AND APPARATUS FOR DELIVERY OF OCULAR IMPLANTS See Plans and Pricing
>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 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
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
1581193 SPC/GB12/047 United Kingdom See Plans and Pricing PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1581193 122012000081 Germany See Plans and Pricing PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1581193 C300552 Netherlands See Plans and Pricing PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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