Sklice is a drug owned by Arbor Pharmaceuticals Llc. It is protected by 3 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2027. Details of Sklice'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). | |||
| US8927595 | Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment resistant strains of head lice |
Oct, 2027
(2 years from now) | Active |
| US8791153 | Topical avermectin formulations and methods for elimination and prophylaxis of susceptible and treatment-resistant strains of head lice |
Oct, 2027
(2 years from now) | Active |
| US6103248 | Topical preparation and therapy for head lice |
May, 2018
(6 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 Sklice's patents.
Latest Legal Activities on Sklice's Patents
Given below is the list of recent legal activities going on the following patents of Sklice.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Jan, 2022 | US8791153 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Jan, 2018 | US8791153 |
| Recordation of Patent Grant Mailed Critical | 29 Jul, 2014 | US8791153 |
| Patent Issue Date Used in PTA Calculation Critical | 29 Jul, 2014 | US8791153 |
| Email Notification Critical | 10 Jul, 2014 | US8791153 |
| Issue Notification Mailed Critical | 09 Jul, 2014 | US8791153 |
| Dispatch to FDC | 27 Jun, 2014 | US8791153 |
| Application Is Considered Ready for Issue Critical | 26 Jun, 2014 | US8791153 |
| Issue Fee Payment Received Critical | 23 Jun, 2014 | US8791153 |
| Issue Fee Payment Verified Critical | 23 Jun, 2014 | US8791153 |
FDA has granted several exclusivities to Sklice. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sklice, 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 Sklice.
Exclusivity Information
Sklice holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Sklice's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Feb 07, 2015 |
US patents provide insights into the exclusivity only within the United States, but Sklice 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 Sklice's family patents as well as insights into ongoing legal events on those patents.
Sklice's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sklice's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sklice Generic API suppliers:
Ivermectin is the generic name for the brand Sklice. 6 different companies have already filed for the generic of Sklice, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sklice's generic
How can I launch a generic of Sklice before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sklice's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sklice'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 Sklice -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005 | 01 Sep, 2017 | 1 | 06 May, 2020 | 12 Oct, 2027 | Eligible |
Alternative Brands for Sklice
Sklice which is used for treating head lice infestations., has several other brand drugs using the same active ingredient (Ivermectin). 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 | |
|---|---|---|
| Galderma Labs Lp |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ivermectin, Sklice's active ingredient. Check the complete list of approved generic manufacturers for Sklice
About Sklice
Sklice is a drug owned by Arbor Pharmaceuticals Llc. It is used for treating head lice infestations. Sklice uses Ivermectin as an active ingredient. Sklice was launched by Arbor Pharms Llc in 2012.
Approval Date:
Sklice was approved by FDA for market use on 07 February, 2012.
Active Ingredient:
Sklice uses Ivermectin as the active ingredient. Check out other Drugs and Companies using Ivermectin ingredient
Treatment:
Sklice is used for treating head lice infestations.
Dosage:
Sklice is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5% | LOTION | Over the counter | TOPICAL |