Ozurdex is a drug owned by Abbvie Inc. It is protected by 17 US drug patents filed from 2013 to 2020 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 01, 2023. Details of Ozurdex's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6899717 | Methods and apparatus for delivery of ocular implants |
Nov, 2023
(1 year, 8 months ago) |
Expired
|
| US8034366 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US8034370 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US10702539 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US9192511 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US10076526 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US8506987 | Ocular implant made by a double extrusion process |
Jan, 2023
(2 years ago) |
Expired
|
| US7767223 | Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use |
Nov, 2021
(3 years ago) |
Expired
|
| US8043628 | Methods for reducing edema |
Oct, 2020
(4 years ago) |
Expired
|
| US9592242 | Methods for treating edema in the eye and intraocular implants for use therefor |
Oct, 2020
(4 years ago) |
Expired
|
| US6726918 | Methods for treating inflammation-mediated conditions of the eye |
Oct, 2020
(4 years ago) |
Expired
|
| US8063031 | Implants and methods for treating inflammation-mediated conditions of the eye |
Oct, 2020
(4 years ago) |
Expired
|
| US7033605 | Methods for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor |
Oct, 2020
(4 years ago) |
Expired
|
| US9775849 | Implants and methods for treating inflammation-mediated conditions of the eye |
Oct, 2020
(4 years ago) |
Expired
|
| US8088407 | Method for reducing or preventing transplant rejection in the eye and intraocular implants for use therefor |
Oct, 2020
(4 years ago) |
Expired
|
| US9012437 | Implants and methods for treating inflammation-mediated conditions of the eye |
Oct, 2020
(4 years ago) |
Expired
|
| US9283178 | Methods for treating edema in the eye and intraocular implants for use therefor |
Oct, 2020
(4 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ozurdex's patents.
Latest Legal Activities on Ozurdex's Patents
Given below is the list of recent legal activities going on the following patents of Ozurdex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 22 Apr, 2024 | US9283178 |
| Maintenance Fee Reminder Mailed Critical | 26 Feb, 2024 | US10702539 |
| Expire Patent Critical | 05 Feb, 2024 | US8088407 |
| Expire Patent Critical | 01 Jan, 2024 | US9192511 |
| Expire Patent Critical | 25 Dec, 2023 | US8063031 |
| Expire Patent Critical | 27 Nov, 2023 | US8043628 |
| Expire Patent Critical | 13 Nov, 2023 | US8034366 |
| Expire Patent Critical | 13 Nov, 2023 | US8034370 |
| Maintenance Fee Reminder Mailed Critical | 06 Nov, 2023 | US9283178 |
| Maintenance Fee Reminder Mailed Critical | 21 Aug, 2023 | US8088407 |
FDA has granted several exclusivities to Ozurdex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ozurdex, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ozurdex.
Exclusivity Information
Ozurdex holds 3 exclusivities. All of its exclusivities have expired in 2017. Details of Ozurdex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 17, 2012 |
| New Indication(I-686) | Jun 29, 2017 |
| Orphan Drug Exclusivity(ODE) | Sep 24, 2017 |
Several oppositions have been filed on Ozurdex's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Ozurdex's generic, the next section provides detailed information on ongoing and past EP oppositions related to Ozurdex patents.
Ozurdex's Oppositions Filed in EPO
Ozurdex has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 18, 2013, by Generics [Uk] Limited. This opposition was filed on patent number EP07017089A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10185774A | Dec, 2013 | Generics [UK] Limited | Revoked |
| EP07017089A | Dec, 2013 | Generics [UK] Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Ozurdex is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ozurdex's family patents as well as insights into ongoing legal events on those patents.
Ozurdex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ozurdex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ozurdex Generic API suppliers:
Dexamethasone is the generic name for the brand Ozurdex. 30 different companies have already filed for the generic of Ozurdex, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ozurdex's generic
Alternative Brands for Ozurdex
Ozurdex which is used for treating eye conditions such as diabetic macular edema, macular edema, non-infectious uveitis, and uveitis by delivering an ocular implant., has several other brand drugs using the same active ingredient (Dexamethasone). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Dexcel |
| |
| Eyepoint Pharms |
| |
| Harrow Eye |
| |
| Ocular Therapeutix |
| |
| Sandoz |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexamethasone, Ozurdex's active ingredient. Check the complete list of approved generic manufacturers for Ozurdex
About Ozurdex
Ozurdex is a drug owned by Abbvie Inc. It is used for treating eye conditions such as diabetic macular edema, macular edema, non-infectious uveitis, and uveitis by delivering an ocular implant. Ozurdex uses Dexamethasone as an active ingredient. Ozurdex was launched by Abbvie in 2009.
Approval Date:
Ozurdex was approved by FDA for market use on 17 June, 2009.
Active Ingredient:
Ozurdex uses Dexamethasone as the active ingredient. Check out other Drugs and Companies using Dexamethasone ingredient
Treatment:
Ozurdex is used for treating eye conditions such as diabetic macular edema, macular edema, non-infectious uveitis, and uveitis by delivering an ocular implant.
Dosage:
Ozurdex is available in implant form for intravitreal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.7MG | IMPLANT | Prescription | INTRAVITREAL |