Olux E is a drug owned by Norvium Bioscience Llc. It is protected by 4 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 05, 2028. Details of Olux E'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). | |||
| US8460641 | Microemulsion process and composition |
Nov, 2028
(3 years from now) | Active |
| US8962000 | Microemulsion and sub-micron emulsion process and compositions |
Aug, 2025
(8 months from now) | Active |
| US7029659 | Mousse composition |
Sep, 2019
(5 years ago) |
Expired
|
| US6730288 | Mousse composition |
Sep, 2019
(5 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 Olux E's patents.
Latest Legal Activities on Olux E's Patents
Given below is the list of recent legal activities going on the following patents of Olux E.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8460641 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Sep, 2017 | US7029659 (Litigated) |
| Post Issue Communication - Certificate of Correction | 04 Dec, 2014 | US8460641 |
| Email Notification Critical | 03 Oct, 2014 | US8460641 |
| Mail-Petition Decision - Dismissed Critical | 30 Sep, 2014 | US8460641 |
| Petition Decision - Dismissed Critical | 29 Sep, 2014 | US8460641 |
| Adjustment of PTA Calculation by PTO | 27 Sep, 2014 | US8460641 |
| Post Issue Communication - Certificate of Correction | 04 Oct, 2013 | US8460641 |
| Petition Entered | 09 Aug, 2013 | US8460641 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Jun, 2013 | US8460641 |
Several oppositions have been filed on Olux E'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 Olux E's generic, the next section provides detailed information on ongoing and past EP oppositions related to Olux E patents.
Olux E's Oppositions Filed in EPO
Olux E has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 14, 2014, by Generics [Uk] Limited. This opposition was filed on patent number EP05775966A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP05775966A | May, 2014 | Henkel AG & Co. KGaA | Patent maintained as amended |
| EP05775966A | May, 2014 | Generics [UK] Limited | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Olux E 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 Olux E's family patents as well as insights into ongoing legal events on those patents.
Olux E's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Olux E's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 05, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Olux E Generic API suppliers:
Clobetasol Propionate is the generic name for the brand Olux E. 35 different companies have already filed for the generic of Olux E, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Olux E's generic
How can I launch a generic of Olux E before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Olux E's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Olux E's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Olux E -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 25 Feb, 2010 | 1 | 14 Aug, 2012 | 08 Sep, 2019 | Eligible |
Alternative Brands for Olux E
Olux E which is used for treating skin conditions that respond to corticosteroids., has several other brand drugs using the same active ingredient (Clobetasol Propionate). 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 | |
|---|---|---|
| Eyenovia |
| |
| Galderma Labs |
| |
| Galderma Labs Lp |
| |
| Norvium Bioscience |
| |
| Primus Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Clobetasol Propionate, Olux E's active ingredient. Check the complete list of approved generic manufacturers for Olux E
About Olux E
Olux E is a drug owned by Norvium Bioscience Llc. It is used for treating skin conditions that respond to corticosteroids. Olux E uses Clobetasol Propionate as an active ingredient. Olux E was launched by Norvium Bioscience in 2007.
Approval Date:
Olux E was approved by FDA for market use on 12 January, 2007.
Active Ingredient:
Olux E uses Clobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Clobetasol Propionate ingredient
Treatment:
Olux E is used for treating skin conditions that respond to corticosteroids.
Dosage:
Olux E is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | AEROSOL, FOAM | Discontinued | TOPICAL |