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Generated: July 24, 2017
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.| Tradenames: | 31 |
| Patents: | 18 |
| Applicants: | 46 |
| NDAs: | 123 |
| Drug Master File Entries: see list | 39 |
| Suppliers / Packagers: see list | 34 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 1,958 |
| Therapeutic Class: | Ophthalmic Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | dexamethasone at DailyMed |
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
| 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;INJECTION | 084342-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Sun Pharm Inds | DEXAMETHASONE | dexamethasone | TABLET;ORAL | 084765-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Pharmafair | NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE | dexamethasone sodium phosphate; neomycin sulfate | SOLUTION/DROPS;OPHTHALMIC | 062539-001 | Jan 10, 1985 | DISCN | No | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Organon Usa Inc | HEXADROL | dexamethasone sodium phosphate | INJECTABLE;INJECTION | 014694-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,846,468 | Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor | ► Subscribe | |||||||||||||||||||||||||||
| 7,090,681 | Methods and apparatus for delivery of ocular implants | ► Subscribe | |||||||||||||||||||||||||||
| 8,048,445 | Ocular implant made by a double extrusion process | ► Subscribe | |||||||||||||||||||||||||||
| 7,468,065 | Apparatus for delivery of ocular implants | ► Subscribe | |||||||||||||||||||||||||||
| 8,242,099 | Implants 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2006525953 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200501251 | ► Subscribe | |||||||||||||||||||||||||||
| Cyprus | 1107823 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 3628679 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1776091 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB12/058 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 00552 | Netherlands | ► Subscribe | PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727 | ||||||||||||||||||||||||||
| 2012000081 | Germany | ► Subscribe | PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727 | ||||||||||||||||||||||||||
| C0012 | France | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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