DEXAMETHASONE - Generic Drug Details

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-one suppliers are listed for this compound.

Summary for DEXAMETHASONE

International Patents:	71
US Patents:	14
Tradenames:	34
Applicants:	64
NDAs:	147
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	3,400
Patent Applications:	7,332
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for DEXAMETHASONE
Drug Sales Revenues:	Drug sales revenues for DEXAMETHASONE
What excipients (inactive ingredients) are in DEXAMETHASONE?	DEXAMETHASONE excipients list
DailyMed Link:	DEXAMETHASONE at DailyMed

See drug prices for DEXAMETHASONE

See drug sales revenues for DEXAMETHASONE

Recent Clinical Trials for DEXAMETHASONE

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

Sponsor	Phase
Dipenkumar Modi	Phase 2
National Trauma Center	N/A
Genmab	Phase 2

See all DEXAMETHASONE clinical trials

Pharmacology for DEXAMETHASONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for DEXAMETHASONE

Anti-Inflammatory Agents

Antiemetics

Antineoplastic Agents, Hormonal

Glucocorticoids

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
Bausch And Lomb	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	064135-001	Sep 13, 1995	AT	RX	No	No
Novitium Pharma	DEXAMETHASONE	dexamethasone	TABLET;ORAL	215604-005	Oct 5, 2023	AB	RX	No	No
Sun Pharm Industries	DEXAMETHASONE	dexamethasone	TABLET;ORAL	084013-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bionpharma	DEXAMETHASONE	dexamethasone	TABLET;ORAL	217001-001	Apr 19, 2023	AB	RX	No	No
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009		RX	Yes	Yes

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
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009
Abbvie	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009

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

International Patents for DEXAMETHASONE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1104286
World Intellectual Property Organization (WIPO)	2014190248
Japan	2021512670	注射器から少量の用量を装填および送達するためのシステム、キット、および方法
Canada	2339482	SYSTEMES D'ADMINISTRATION DE MEDICAMENTS AU MOYEN D'HYDROGELS COMPOSITES (COMPOSITE HYDROGEL DRUG DELIVERY SYSTEMS)
Canada	3088420	SYSTEMES, KITS ET PROCEDES POUR CHARGER ET DISTRIBUER UNE DOSE DE PETIT VOLUME A PARTIR D'UNE SERINGUE (SYSTEMS, KITS AND METHODS FOR LOADING AND DELIVERING A SMALL VOLUME DOSE FROM A SYRINGE)

Supplementary Protection Certificates for DEXAMETHASONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	SPC/GB12/058	United Kingdom		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
1581193	SPC/GB12/047	United Kingdom		PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	13C0012	France		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