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, Chartwell Molecular, Kanchan Hlthcare, Pharmobedient Cnsltg, Rising, Aspen Global Inc, Abbvie, Ocular Therapeutix, Watson Labs, Harrow Eye, Eyepoint Pharms, Abraxeolus, Alvogen, Amneal, Apotex, Bausch, Bionpharma, Chartwell Rx, Corepharma, Impax Labs, Key Therap, Larken Labs Inc, Novitium Pharma, Phoenix Labs Ny, Prasco, Pvt Form, Roxane, Sun Pharm Industries, Upsher Smith, Whiteworth Town Plsn, Zydus Lifesciences, 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, Micro Labs, Mylan Labs Ltd, Somerset, Somerset Theraps Llc, Teva Parenteral, 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-nine NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for DEXAMETHASONE

International Patents:	72
US Patents:	14
Tradenames:	34
Applicants:	65
NDAs:	149
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	3,474
Patent Applications:	7,383
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
Albert Einstein College of Medicine	Phase 1
Columbia University	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1

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

Anatomical Therapeutic Chemical (ATC) Classes for DEXAMETHASONE

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

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
Sun Pharm Industries	DEXAMETHASONE	dexamethasone	TABLET;ORAL	084766-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	DEXAMETHASONE	dexamethasone	TABLET;ORAL	084763-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prasco	DEXAMETHASONE	dexamethasone	TABLET;ORAL	080399-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solvay	DEXONE 0.5	dexamethasone	TABLET;ORAL	084991-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	TOBRAMYCIN AND DEXAMETHASONE	dexamethasone; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	212991-001	Jul 15, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	081126-001	Aug 31, 1990		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck	DECADERM	dexamethasone	GEL;TOPICAL	013538-001	Approved Prior to Jan 1, 1982		DISCN	No	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

Expired US Patents for DEXAMETHASONE

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2701773	GUIDES DE DOSE POUR SERINGUE D'INJECTION (DOSE GUIDES FOR INJECTION SYRINGE)	⤷ Sign Up
Australia	2018200074	Biomaterials for track and puncture closure	⤷ Sign Up
Japan	2016526039	白内障手術後の炎症における徐放性デキサメタゾンの使用	⤷ Sign Up
China	105407896	Use of sustained release dexamethasone in post-cataract surgery inflammation	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2019123453		⤷ Sign Up
Canada	2339482	SYSTEMES D'ADMINISTRATION DE MEDICAMENTS AU MOYEN D'HYDROGELS COMPOSITES (COMPOSITE HYDROGEL DRUG DELIVERY SYSTEMS)	⤷ Sign Up
Japan	7394770		⤷ Sign Up
>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	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1429780	13C0012	France	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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