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.

Summary for dexamethasone

International Patents:	194
US Patents:	22
Tradenames:	34
Applicants:	61
NDAs:	138
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	3,286
Patent Applications:	7,287
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

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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

Sponsor	Phase
Acacia Pharma Ltd	Phase 2/Phase 3
Premier Research Group plc	Phase 2/Phase 3
Amicus CD LLC	Phase 2/Phase 3

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

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Glossary

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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

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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

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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

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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

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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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