Ozurdex Patent Expiration

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, 1 month ago)

Expired
US8034366 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months ago)

Expired
US8034370 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months ago)

Expired
US10702539 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months ago)

Expired
US9192511 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months ago)

Expired
US10076526 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months ago)

Expired
US8506987 Ocular implant made by a double extrusion process
Jan, 2023

(1 year, 11 months 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.

Given below is the list of recent legal activities going on the following patents of Ozurdex.

Activity Date Patent Number
Patent litigations
Expire Patent 22 Apr, 2024 US9283178
Maintenance Fee Reminder Mailed 26 Feb, 2024 US10702539
Expire Patent 05 Feb, 2024 US8088407
Expire Patent 01 Jan, 2024 US9192511
Expire Patent 25 Dec, 2023 US8063031
Expire Patent 27 Nov, 2023 US8043628
Expire Patent 13 Nov, 2023 US8034366
Expire Patent 13 Nov, 2023 US8034370
Maintenance Fee Reminder Mailed 06 Nov, 2023 US9283178
Maintenance Fee Reminder Mailed 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

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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
Patent litigations
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

Ozurdex has patent protection in a total of 27 countries. It's US patent count contributes only to 18.9% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Ozurdex.

Family Patents

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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
Hemady
Eyepoint Pharms
Dexycu Kit
Harrow Eye
Tobradex St
Ocular Therapeutix
Dextenza
Sandoz
Ciprodex


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