OZURDEX Drug Patent Profile
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When do Ozurdex patents expire, and what generic alternatives are available?
Ozurdex is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug.
This drug has one hundred and twenty-seven patent family members in twenty-eight countries.
The generic ingredient in OZURDEX is dexamethasone. There are thirty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the dexamethasone profile page.
DrugPatentWatch® 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: | 127 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 115 |
| Clinical Trials: | 93 |
| Patent Applications: | 4,532 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OZURDEX |
| What excipients (inactive ingredients) are in OZURDEX? | OZURDEX excipients list |
| DailyMed Link: | OZURDEX at DailyMed |
Recent Clinical Trials for OZURDEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Oxular Limited | Phase 2 |
| Hospital for Special Surgery, New York | Phase 4 |
| Karyopharm Therapeutics Inc | Phase 2 |
Pharmacology for OZURDEX
| Drug Class | Corticosteroid |
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for OZURDEX
US Patents and Regulatory Information for OZURDEX
OZURDEX is protected by eleven US patents.
Patents protecting OZURDEX
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF DIABETIC MACULAR EDEMA
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR CENTRAL RETINAL VEIN OCCLUSION (CRVO)
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
Methods and apparatus for delivery of ocular implants
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION OF THE APPROVED LABELING OF OZURDEX
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MACULAR EDEMA
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF UVEITIS
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MACULAR EDEMA
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF UVEITIS
Ocular implant made by a double extrusion process
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for OZURDEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Abbvie | OZURDEX | dexamethasone | IMPLANT;INTRAVITREAL | 022315-001 | Jun 17, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for OZURDEX
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| AbbVie Deutschland GmbH & Co. KG | Ozurdex | dexamethasone | EMEA/H/C/001140 Ozurdex is indicated for the treatment of adult patients with macular oedema following either branch retinal-vein occlusion (BRVO) or central retinal-vein occlusion (CRVO).Ozurdex is indicated for the treatment of adult patients with inflammation of the posterior segment of the eye presenting as noninfectious uveitis.Ozurdex is indicated for the treatment of adult patients with visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. |
Authorised | no | no | no | 2010-07-26 | |
| THERAVIA | Neofordex | dexamethasone | EMEA/H/C/004071 Treatment of multiple myeloma. |
Authorised | no | no | no | 2016-03-16 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for OZURDEX
See the table below for patents covering OZURDEX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 102319432 | Ocular implant made by a double extrusion process | ⤷ Try a Trial |
| Japan | 3628679 | ⤷ Try a Trial | |
| Poland | 382452 | Implant do oka wytwarzany w procesie podwójnego wytłaczania (Eye implant produced in the process of double pressing) | ⤷ Try a Trial |
| Japan | 2006193532 | DELIVERY SYSTEM FOR BIOERODIBLE DRUG FOR EYE | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for OZURDEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1429780 | SPC/GB12/058 | United Kingdom | ⤷ Try a 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 |
| 1429780 | 13C0012 | France | ⤷ Try a 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 | ⤷ Try a Trial | PRODUCT NAME: DEXAMETHASONE; REGISTERED: UK EU/1/10/638/001 20100727 |
| 1581193 | 122012000081 | Germany | ⤷ Try a Trial | PRODUCT NAME: DEXAMETHASON; REGISTRATION NO/DATE: EU/1/10/638/001 20100727 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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 verification 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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