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Generated: November 19, 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, Xspire Pharma, Par Pharm, Sti Pharma Llc, Wockhardt Eu Operatn, Larken Labs Inc, 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-four NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dexamethasone has one hundred and thirty-four patent family members in twenty-six countries and five supplementary protection certificates in four countries.

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

Pharmacology for dexamethasone

Medical Subject Heading (MeSH) Categories for dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
DEXAMETHASONE
dexamethasone
TABLET;ORAL084457-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Parenteral
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION081126-001Aug 31, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION083702-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Abraxis Pharm
DEXAMETHASONE
dexamethasone sodium phosphate
INJECTABLE;INJECTION088448-001Jan 25, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Merck
DECADRON
dexamethasone sodium phosphate
SOLUTION/DROPS;OPHTHALMIC, OTIC011984-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Wyeth Ayerst
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION085641-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Impax Labs
DEXAMETHASONE
dexamethasone
TABLET;ORAL085376-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Parenteral
DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone sodium phosphate
INJECTABLE;INJECTION081125-001Aug 31, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
dexamethasone sodium phosphate
INJECTABLE;INJECTION040491-001Apr 11, 2003APRXNoYes► Subscribe► Subscribe► Subscribe
Watson Labs
DEXAMETHASONE
dexamethasone
SUSPENSION/DROPS;OPHTHALMIC089170-001May 9, 1989DISCNNoNo► 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
8,048,445Ocular implant made by a double extrusion process► Subscribe
8,828,446Method for reducing transplant rejection in the eye and intraocular implants for use therefor► Subscribe
8,242,099Implants and methods for treating inflammation-mediated conditions of the eye► Subscribe
8,071,120Methods for treating neovascularization and intravitreal implants► Subscribe
7,147,644Apparatus for delivery of ocular implants► Subscribe
7,625,582Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor► Subscribe
6,699,493 Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor► Subscribe
7,846,468Methods 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
7,090,681Methods and apparatus for delivery of ocular implants► 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
Poland223153► Subscribe
Japan2004501954► Subscribe
Canada2576392► Subscribe
Taiwan200621263► Subscribe
Spain2613028► Subscribe
Spain2412881► Subscribe
Germany60114229► Subscribe
South Korea101365772► Subscribe
Austria306951► Subscribe
Japan2008509727► 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
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
2012000081Germany► SubscribePRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727
00552Netherlands► SubscribePRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727
C/GB12/047United Kingdom► SubscribePRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Julphar
QuintilesIMS
Colorcon
Healthtrust
Dow
Cipla
Medtronic
Mallinckrodt
Fish and Richardson

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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