Xeglyze is a drug owned by Hatchtech Pty Ltd. It is protected by 5 US drug patents filed in 2020. Out of these, 2 drug patents are active and 3 have expired. Xeglyze's patents have been open to challenges since 24 July, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 17, 2034. Details of Xeglyze's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9839631 | Methods and compositions for controlling ectoparasites |
Jul, 2024
(9 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10292389 | Pediculicidal composition |
Dec, 2034
(9 years from now) | Active |
| US7812163 | Methods and compositions for controlling ectoparasites |
Oct, 2026
(1 year, 5 months from now) | Active |
| US8212038 | Methods and compositions for controlling ectoparasites |
Jul, 2024
(9 months ago) |
Expired
|
| US9357783 | Methods and compositions for controlling ectoparasites |
Jul, 2024
(9 months 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 Xeglyze's patents.
Latest Legal Activities on Xeglyze's Patents
Given below is the list of recent legal activities going on the following patents of Xeglyze.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 03 May, 2024 | US8212038 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US9357783 |
| Email Notification Critical | 03 May, 2024 | US9839631 |
| Email Notification Critical | 03 May, 2024 | US9357783 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US8212038 |
| Email Notification Critical | 03 May, 2024 | US7812163 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US7812163 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US9839631 |
| Email Notification Critical | 18 Apr, 2024 | US10292389 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Apr, 2024 | US10292389 |
FDA has granted several exclusivities to Xeglyze. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xeglyze, 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 Xeglyze.
Exclusivity Information
Xeglyze holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Xeglyze's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 24, 2025 |
US patents provide insights into the exclusivity only within the United States, but Xeglyze 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 Xeglyze's family patents as well as insights into ongoing legal events on those patents.
Xeglyze's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xeglyze's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xeglyze Generics:
There are no approved generic versions for Xeglyze as of now.
About Xeglyze
Xeglyze is a drug owned by Hatchtech Pty Ltd. It is used for treating head lice infestation in patients 6 months of age and older. Xeglyze uses Abametapir as an active ingredient. Xeglyze was launched by Hatchtech in 2020.
Approval Date:
Xeglyze was approved by FDA for market use on 24 July, 2020.
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 Xeglyze is 24 July, 2020, its NCE-1 date is estimated to be 24 July, 2024.
Active Ingredient:
Xeglyze uses Abametapir as the active ingredient. Check out other Drugs and Companies using Abametapir ingredient
Treatment:
Xeglyze is used for treating head lice infestation in patients 6 months of age and older.
Dosage:
Xeglyze is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.74% | LOTION | Discontinued | TOPICAL |