Iluvien is a drug owned by Alimera Sciences Inc. It is protected by 5 US drug patents filed in 2014. Out of these, 1 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 12, 2027. Details of Iluvien'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6217895 | Method for treating and/or preventing retinal diseases with sustained release corticosteroids |
Mar, 2019
(5 years ago) |
Expired
|
| US6548078 | Method for treating and/or preventing retinal diseases with sustained release corticosteroids |
Mar, 2019
(5 years ago) |
Expired
|
| US8252307 | Method for treating and/or preventing retinal diseases with sustained release corticosteroids |
Jun, 2019
(5 years ago) |
Expired
|
| US6375972 | Sustained release drug delivery devices, methods of use, and methods of manufacturing thereof |
Apr, 2020
(4 years ago) |
Expired
|
| US8871241 | Injectable sustained release delivery devices |
Aug, 2027
(3 years from now) | Active |
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 Iluvien's patents.
Latest Legal Activities on Iluvien's Patents
Given below is the list of recent legal activities going on the following patents of Iluvien.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Apr, 2022 | US8871241 |
| Expire Patent | 05 Oct, 2020 | US8252307 |
| Maintenance Fee Reminder Mailed | 20 Apr, 2020 | US8252307 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Apr, 2018 | US8871241 |
| Correspondence Address Change | 18 Apr, 2017 | US8871241 |
| Patent Issue Date Used in PTA Calculation | 28 Oct, 2014 | US8871241 |
| Recordation of Patent Grant Mailed | 28 Oct, 2014 | US8871241 |
| Email Notification | 09 Oct, 2014 | US8871241 |
| Issue Notification Mailed | 08 Oct, 2014 | US8871241 |
| Dispatch to FDC | 30 Sep, 2014 | US8871241 |
FDA has granted several exclusivities to Iluvien. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Iluvien, 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 Iluvien.
Exclusivity Information
Iluvien holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Iluvien's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 26, 2017 |
US patents provide insights into the exclusivity only within the United States, but Iluvien 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 Iluvien's family patents as well as insights into ongoing legal events on those patents.
Iluvien's family patents
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Generic Launch
Generic Release Date:
Iluvien's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Iluvien Generics:
Fluocinolone Acetonide is the generic name for the brand Iluvien. 27 different companies have already filed for the generic of Iluvien, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Iluvien's generic
About Iluvien
Iluvien is a drug owned by Alimera Sciences Inc. It is used for treating diabetic macular edema. Iluvien uses Fluocinolone Acetonide as an active ingredient. Iluvien was launched by Alimera Sciences Inc in 2014.
Market Authorisation Date:
Iluvien was approved by FDA for market use on 26 September, 2014.
Active Ingredient:
Iluvien uses Fluocinolone Acetonide as the active ingredient. Check out other Drugs and Companies using Fluocinolone Acetonide ingredient
Treatment:
Iluvien is used for treating diabetic macular edema.
Dosage:
Iluvien is available in implant form for intravitreal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.19MG | IMPLANT | Prescription | INTRAVITREAL |