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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
Queensland Health
Covington
Chubb
Deloitte
Harvard Business School
McKinsey
AstraZeneca
Daiichi Sankyo

Generated: July 24, 2017

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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 dexamethasone patent protection?

Dexamethasone
is the generic ingredient in thirty-one branded drugs marketed by ECR, Phoenix Labs Ny, West-ward Pharms Int, Sun Pharm Inds, Roxane, Allergan, Watson Labs, Pvt Form, Novartis Pharms Corp, Whiteworth Town Plsn, Merck, Upsher Smith, Par Pharm, Sti Pharma Llc, Wockhardt Eu Operatn, Organon Usa Inc, Impax Labs, Vintage Pharms, Solvay, Lyne, Allergan Herbert, Alpharma Us Pharms, Idt Australia Ltd, Watson Labs Teva, Mylan Labs Ltd, Ucb Inc, Fresenius Kabi Usa, Intl Medication, Teva Parenteral, Pharmafair, Luitpold, Wyeth Ayerst, Cent Pharms, Alcon, Abraxis Pharm, Bel Mar, Akorn, Dell Labs, Lyphomed, Bausch And Lomb, Sola Barnes Hind, Sandoz Inc, Aurobindo Pharma Ltd, Alcon Pharms Ltd, Perrigo Co Tennessee, and Novartis, and is included in one hundred and twenty-three NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: dexamethasone

Tradenames:31
Patents:18
Applicants:46
NDAs:123
Drug Master File Entries: see list39
Suppliers / Packagers: see list34
Bulk Api Vendors: see list76
Clinical Trials: see list1,958
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:dexamethasone at DailyMed

Pharmacology for Ingredient: dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cent Pharms
DEXACEN-4
dexamethasone sodium phosphate
INJECTABLE;INJECTION084342-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
DEXAMETHASONE
dexamethasone
TABLET;ORAL084765-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Pharmafair
NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate; neomycin sulfate
SOLUTION/DROPS;OPHTHALMIC062539-001Jan 10, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Allergan
OZURDEX
dexamethasone
IMPLANT;INTRAVITREAL022315-001Jun 17, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Organon Usa Inc
HEXADROL
dexamethasone sodium phosphate
INJECTABLE;INJECTION014694-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: dexamethasone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,846,468Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor► Subscribe
7,090,681Methods and apparatus for delivery of ocular implants► Subscribe
8,048,445Ocular implant made by a double extrusion process► Subscribe
7,468,065Apparatus for delivery of ocular implants► Subscribe
8,242,099Implants and methods for treating inflammation-mediated conditions of the eye► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: dexamethasone

Country Document Number Estimated Expiration
Japan2006525953► Subscribe
South Africa200501251► Subscribe
Cyprus1107823► Subscribe
Japan3628679► Subscribe
Denmark1776091► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DEXAMETHASONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB12/058United Kingdom► SubscribePRODUCT 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
00552Netherlands► SubscribePRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
2012000081Germany► SubscribePRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
C0012France► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim
Covington
US Army
Colorcon
Deloitte
Farmers Insurance
Mallinckrodt
Harvard Business School
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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