Lexette is a drug owned by Mayne Pharma Llc. It is protected by 3 US drug patents filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 30, 2037. Details of Lexette'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). | |||
|
US10857159 (Pediatric) | Halobetasol foam composition and method of use thereof |
May, 2037
(12 years from now) | Active |
| US11020407 | Corticosteroid containing foam compositions and method of manufacture thereof |
Nov, 2036
(12 years from now) | Active |
| US10857159 | Halobetasol foam composition and method of use thereof |
Nov, 2036
(12 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 Lexette's patents.
Latest Legal Activities on Lexette's Patents
Given below is the list of recent legal activities going on the following patents of Lexette.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jun, 2024 | US10857159 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Jun, 2021 | US11020407 |
| Recordation of Patent Grant Mailed Critical | 01 Jun, 2021 | US11020407 |
| Email Notification Critical | 14 May, 2021 | US11020407 |
| Issue Notification Mailed Critical | 12 May, 2021 | US11020407 |
| Dispatch to FDC | 05 May, 2021 | US11020407 |
| Application Is Considered Ready for Issue Critical | 03 May, 2021 | US11020407 |
| Issue Fee Payment Verified Critical | 30 Apr, 2021 | US11020407 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 30 Apr, 2021 | US11020407 |
| Issue Fee Payment Received Critical | 30 Apr, 2021 | US11020407 |
FDA has granted several exclusivities to Lexette. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Lexette, 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 Lexette.
Exclusivity Information
Lexette holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Lexette's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | May 24, 2021 |
| New Patient Population(NPP) | Aug 18, 2024 |
US patents provide insights into the exclusivity only within the United States, but Lexette 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 Lexette's family patents as well as insights into ongoing legal events on those patents.
Lexette's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Lexette's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 30, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lexette Generic API suppliers:
Halobetasol Propionate is the generic name for the brand Lexette. 6 different companies have already filed for the generic of Lexette, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lexette's generic
How can I launch a generic of Lexette before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lexette's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lexette'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 Lexette -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 28 Jan, 2021 | 1 | 30 Nov, 2036 |
Alternative Brands for Lexette
Lexette which is used for treating plaque psoriasis in patients 18 years of age and older., has several other brand drugs using the same active ingredient (Halobetasol 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Halobetasol Propionate, Lexette's active ingredient. Check the complete list of approved generic manufacturers for Lexette
About Lexette
Lexette is a drug owned by Mayne Pharma Llc. It is used for treating plaque psoriasis in patients 18 years of age and older. Lexette uses Halobetasol Propionate as an active ingredient. Lexette was launched by Mayne Pharma in 2018.
Approval Date:
Lexette was approved by FDA for market use on 24 May, 2018.
Active Ingredient:
Lexette uses Halobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Halobetasol Propionate ingredient
Treatment:
Lexette is used for treating plaque psoriasis in patients 18 years of age and older.
Dosage:
Lexette is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% | AEROSOL, FOAM | Prescription | TOPICAL |