Ulesfia is a drug owned by Shionogi Inc. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Ulesfia's patents have been open to challenges since 09 April, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be May 19, 2024. Details of Ulesfia'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). | |||
| US7294342 | Ectoparasite asphyxiator compositions and methods for their application |
May, 2024
(6 months ago) |
Expired
|
| US6793931 | Ectoparasite asphyxiator compositions and methods for their applications |
Jul, 2022
(2 years ago) |
Expired
|
| US5858383 | Methods and compositions for topical treatment of ectoparasites |
Aug, 2017
(7 years ago) |
Expired
|
| US6139859 | Methods and compositions for topical treatment of ectoparasites |
Aug, 2017
(7 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 Ulesfia's patents.
Latest Legal Activities on Ulesfia's Patents
Given below is the list of recent legal activities going on the following patents of Ulesfia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jul, 2019 | US7294342 (Litigated) |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 25 Jul, 2019 | US7294342 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2019 | US7294342 (Litigated) |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 27 Oct, 2015 | US6793931 |
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 26 Oct, 2015 | US6793931 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed Critical | 16 Sep, 2015 | US6793931 |
| Email Notification Critical | 14 Sep, 2015 | US6793931 |
| Mail O.P. Petition Decision | 14 Sep, 2015 | US6793931 |
| Electronic Review Critical | 14 Sep, 2015 | US6793931 |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Dismissed | 10 Sep, 2015 | US6793931 |
FDA has granted several exclusivities to Ulesfia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ulesfia, 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 Ulesfia.
Exclusivity Information
Ulesfia holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Ulesfia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 09, 2014 |
US patents provide insights into the exclusivity only within the United States, but Ulesfia 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 Ulesfia's family patents as well as insights into ongoing legal events on those patents.
Ulesfia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ulesfia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ulesfia Generics:
There are no approved generic versions for Ulesfia as of now.
How can I launch a generic of Ulesfia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ulesfia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ulesfia'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 Ulesfia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 | 11 Apr, 2016 | 1 | 19 May, 2024 | Extinguished |
About Ulesfia
Ulesfia is a drug owned by Shionogi Inc. It is used for treating lice infestations through topical application. Ulesfia uses Benzyl Alcohol as an active ingredient. Ulesfia was launched by Shionogi Inc in 2009.
Approval Date:
Ulesfia was approved by FDA for market use on 09 April, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Ulesfia is 09 April, 2009, its NCE-1 date is estimated to be 09 April, 2013.
Active Ingredient:
Ulesfia uses Benzyl Alcohol as the active ingredient. Check out other Drugs and Companies using Benzyl Alcohol ingredient
Treatment:
Ulesfia is used for treating lice infestations through topical application.
Dosage:
Ulesfia is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION | Discontinued | TOPICAL |