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Generated: June 25, 2017
What is the patent landscape for Ozurdex, and when can generic versions of Ozurdex launch?
Ozurdex is a drug marketed by Allergan and is included in one NDA. There are fourteen patents protecting this drug.| Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 66 |
| Clinical Trials: see list | 58 |
| Patent Applications: see list | 9,379 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | OZURDEX 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 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | 8,034,370 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | 9,592,242 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | 8,063,031 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | 8,506,987 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 7,468,065 | Apparatus for delivery of ocular implants | ► Subscribe | |||||||||||||||||||||||||||
| 6,699,493 | Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor | ► Subscribe | |||||||||||||||||||||||||||
| 7,625,582 | Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor | ► Subscribe | |||||||||||||||||||||||||||
| 8,242,099 | Implants and methods for treating inflammation-mediated conditions of the eye | ► Subscribe | |||||||||||||||||||||||||||
| 7,753,916 | Methods 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hong Kong | 1156856 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 306951 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 538380 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2429998 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA05007342 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||
| 2012000081 | Germany | ► Subscribe | PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727 | ||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||
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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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