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OZURDEX Drug Profile
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» See Plans and PricingWhen do Ozurdex patents expire, and what generic alternatives are available?
Ozurdex is a drug marketed by Allergan and is included in one NDA. There are sixteen patents protecting this drug.
This drug has one hundred and fifty-eight patent family members in twenty-seven countries.
The generic ingredient in OZURDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
US ANDA Litigation and Generic Entry Outlook for Ozurdex
A generic version of OZURDEX was approved as dexamethasone by XSPIRE PHARMA on April 28th, 1983.
Summary for OZURDEX
| International Patents: | 158 |
| US Patents: | 16 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 100 |
| Clinical Trials: | 76 |
| Patent Applications: | 4,501 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OZURDEX |
| DailyMed Link: | OZURDEX at DailyMed |
Recent Clinical Trials for OZURDEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Medical College of Wisconsin | Phase 1 |
| Yeungnam University College of Medicine | Phase 4 |
| Hospices Civils de Lyon | Phase 2 |
Pharmacology for OZURDEX
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
US Patents and Regulatory Information for OZURDEX
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Allergan | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for OZURDEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 325505 | Start Trial |
| Mexico | PA05007342 | Start Trial |
| Hong Kong | 1084021 | Start Trial |
| New Zealand | 553891 | Start Trial |
| Norway | 20050934 | Start Trial |
| Cyprus | 1120147 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for OZURDEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1581193 | 122012000081 | Germany | Start Trial | PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727 |
| 1429780 | 13C0012 | France | Start Trial | 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 |
| 1581193 | SPC/GB12/047 | United Kingdom | Start Trial | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| 1429780 | SPC/GB12/058 | United Kingdom | Start Trial | 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 |
| 1581193 | C300552 | Netherlands | Start Trial | PRODUCT NAME: VOOR GEBRUIK IN EEN WERKWIJZE VOOR DE BEHANDELING VAN MACULAIR OEDEEM; REG. NO/DATE: EU/1/10/638/001 20100727 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
