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, 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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for DEXAMETHASONE

International Patents:	196
US Patents:	23
Tradenames:	34
Applicants:	61
NDAs:	138
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	116
Clinical Trials:	3,367
Patent Applications:	5,006
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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
Regeneron Pharmaceuticals	Phase 3
KKS Netzwerk	Phase 3
Deutsche Studiengruppe Multiples Myelom (DSMM)	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
Pharmafair	DEXASPORIN	dexamethasone; neomycin sulfate; polymyxin b sulfate	SUSPENSION/DROPS;OPHTHALMIC	062428-001	May 18, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aspen Global Inc	HEXADROL	dexamethasone sodium phosphate	INJECTABLE;INJECTION	014694-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aspen Global Inc	HEXADROL	dexamethasone sodium phosphate	INJECTABLE;INJECTION	014694-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dell Labs	DEXAMETHASONE SODIUM PHOSPHATE	dexamethasone sodium phosphate	INJECTABLE;INJECTION	083161-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lyne	DEXAMETHASONE	dexamethasone	ELIXIR;ORAL	090891-001	Jul 12, 2011	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
Allergan	OZURDEX	dexamethasone	IMPLANT;INTRAVITREAL	022315-001	Jun 17, 2009	⤷ Try a Trial	⤷ Try a Trial
>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
Norway	342740		⤷ Try a Trial
South Korea	102081808		⤷ Try a Trial
China	111757764	用于从注射器装载和输送小体积剂量的系统、套件和方法 (SYSTEMS, KITS AND METHODS FOR LOADING AND DELIVERING A SMALL VOLUME DOSE FROM A SYRINGE)	⤷ Try a Trial
Norway	20070992		⤷ Try a Trial
European Patent Office	3563839	IMPLANT OCULAIRE BIODÉGRADABLE (BIODEGRADABLE OCULAR IMPLANT)	⤷ Try a Trial
>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	⤷ Try a Trial	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	C300552	Netherlands	⤷ Try a Trial	PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
1581193	SPC/GB12/047	United Kingdom	⤷ Try a Trial	PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
1581193	122012000081	Germany	⤷ Try a Trial	PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
1429780	13C0012	France	⤷ Try a Trial	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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