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Dexamethasone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for dexamethasone?

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

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

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

Summary for Generic Name: dexamethasone

Tradenames:31
Patents:17
Applicants:45
NDAs:123
Drug Master File Entries: see list38
Suppliers / Packagers: see list32
Bulk Api Vendors: see list66
Clinical Trials: see list857
Patent Applications: see list5,038
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck
NEODECADRON
dexamethasone sodium phosphate; neomycin sulfate
SOLUTION/DROPS;OPHTHALMIC050322-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Novartis Pharms Corp
TOBRADEX
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC050592-001Aug 18, 1988RXYesYes► Subscribe► Subscribe
Organon Usa Inc
HEXADROL
dexamethasone sodium phosphate
INJECTABLE;INJECTION014694-003Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe
Bausch And Lomb
NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate; neomycin sulfate
SOLUTION/DROPS;OPHTHALMIC064055-001Oct 30, 1995DISCNNoNo► Subscribe► Subscribe
Bausch And Lomb
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
SOLUTION/DROPS;OPHTHALMIC, OTIC040069-001Jul 26, 1996RXNoNo► 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
8,071,120Methods for treating neovascularization and intravitreal implants► Subscribe
8,242,099Implants and methods for treating inflammation-mediated conditions of the eye► Subscribe
7,625,582Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor► Subscribe
7,753,916Methods and apparatus for delivery of ocular implants► Subscribe
8,778,381Ocular implant made by a double extrusion process► 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
China102319432► Subscribe
European Patent Office2799064► Subscribe
Cyprus1107823► Subscribe
Australia2010235967► Subscribe
Australia2003272575► 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
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
00552Netherlands► SubscribePRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
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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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