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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, Lannett Co Inc, Lyne, Wockhardt Bio Ag, Aspen Global Inc, Allergan, Ocular Therapeutix, Watson Labs, Novartis, Eyepoint Pharms, Ani Pharms Inc, ECR, Fera Pharms Llc, Heritage Pharma, Impax Labs, Larken Labs Inc, Par Pharm, Phoenix Labs Ny, Pvt Form, Roxane, 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, Amneal, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Dr Reddys, 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, Perrigo Co Tennessee, and Eyevance, and is included in one hundred and thirty-two NDAs. There are twenty-nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has two hundred and nineteen patent family members in thirty countries.

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

Summary for dexamethasone

International Patents:	219
US Patents:	29
Tradenames:	34
Applicants:	58
NDAs:	132
Drug Master File Entries:	39
Suppliers / Packagers:	29
Bulk Api Vendors:	101
Clinical Trials:	2,709
Patent Applications:	7,381
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
CHU de Quebec-Universite Laval	Phase 3
Poitiers University Hospital	Phase 3
Jacob Laubach	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
Solvay	DEXONE 1.5	dexamethasone	TABLET;ORAL	084990-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmafair	DEXAIR	dexamethasone sodium phosphate	OINTMENT;OPHTHALMIC	088071-001	Dec 28, 1982		DISCN	No	No
Aurobindo Pharma Ltd	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	210967-001	Jun 7, 2019	AP	RX	No	No
Mylan Labs Ltd	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	040802-001	Aug 29, 2008	AP	RX	No	No

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

International Patents for dexamethasone

Country	Patent Number	Estimated Expiration
Hong Kong	1082902
European Patent Office	2427233
Russian Federation	2007103318
Canada	2429998

Supplementary Protection Certificates for dexamethasone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1581193	C300552	Netherlands		PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
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