Xdemvy is a drug owned by Tarsus Pharmaceuticals Inc. It is protected by 6 US drug patents filed in 2023 out of which none have expired yet. Xdemvy's patents will be open to challenges from 25 July, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 14, 2038. Details of Xdemvy'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. | |||
| US8383659 | Isoxazoline derivatives as pesticides |
Jan, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11690827 | Methods for treating ocular Demodex using lotilaner formulations |
Dec, 2038
(14 years from now) | Active |
| US11690826 | Methods for treating demodex blepharitis using lotilaner formulations |
Dec, 2038
(14 years from now) | Active |
| US11197847 | Isoxazoline parasiticide formulations and methods for treating blepharitis |
Dec, 2038
(14 years from now) | Active |
| US10835517 | Methods for treating ocular demodex using isoxazoline parasiticide formulations |
Dec, 2038
(14 years from now) | Active |
| US11752137 | Ophthalmic compositions for treating ocular Demodex using lotilaner formulations |
Dec, 2038
(14 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 Xdemvy's patents.
Latest Legal Activities on Xdemvy's Patents
Given below is the list of recent legal activities going on the following patents of Xdemvy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 14 May, 2024 | US10835517 |
| Recordation of Patent Grant Mailed Critical | 12 Sep, 2023 | US11752137 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752137 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752137 |
| Email Notification Critical | 12 Sep, 2023 | US11752137 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752137 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Sep, 2023 | US11752137 |
| Email Notification Critical | 24 Aug, 2023 | US11752137 |
| Issue Notification Mailed Critical | 23 Aug, 2023 | US11752137 |
| Application Is Considered Ready for Issue Critical | 27 Jul, 2023 | US11752137 |
FDA has granted several exclusivities to Xdemvy. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xdemvy, 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 Xdemvy.
Exclusivity Information
Xdemvy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Xdemvy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 24, 2028 |
US patents provide insights into the exclusivity only within the United States, but Xdemvy 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 Xdemvy's family patents as well as insights into ongoing legal events on those patents.
Xdemvy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xdemvy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 14, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xdemvy Generics:
There are no approved generic versions for Xdemvy as of now.
About Xdemvy
Xdemvy is a drug owned by Tarsus Pharmaceuticals Inc. It is used for treating demodex blepharitis by applying topically to the eye surface. Xdemvy uses Lotilaner as an active ingredient. Xdemvy was launched by Tarsus in 2023.
Approval Date:
Xdemvy was approved by FDA for market use on 24 July, 2023.
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 Xdemvy is 24 July, 2023, its NCE-1 date is estimated to be 25 July, 2027.
Active Ingredient:
Xdemvy uses Lotilaner as the active ingredient. Check out other Drugs and Companies using Lotilaner ingredient
Treatment:
Xdemvy is used for treating demodex blepharitis by applying topically to the eye surface.
Dosage:
Xdemvy is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25% | SOLUTION/DROPS | Prescription | OPHTHALMIC |