Sorilux is a drug owned by Mayne Pharma Llc. It is protected by 3 US drug patents filed from 2013 to 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 07, 2028. Details of Sorilux'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). | |||
| US8263580 | Vitamin formulation |
May, 2028
(3 years from now) | Active |
| US8269128 | Vacuum switch tube |
May, 2026
(1 year, 5 months from now) | Active |
| US8629128 | Vitamin formulation |
May, 2026
(1 year, 5 months 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 Sorilux's patents.
Latest Legal Activities on Sorilux's Patents
Given below is the list of recent legal activities going on the following patents of Sorilux.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 04 Mar, 2024 | US8269128 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Feb, 2024 | US8263580 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Jun, 2021 | US8629128 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 16 Mar, 2020 | US8269128 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Feb, 2020 | US8263580 |
| Recordation of Patent Grant Mailed Critical | 14 Jan, 2014 | US8629128 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Jan, 2014 | US8629128 |
| Email Notification Critical | 25 Dec, 2013 | US8629128 |
| Issue Notification Mailed Critical | 24 Dec, 2013 | US8629128 |
| Dispatch to FDC | 18 Dec, 2013 | US8629128 |
FDA has granted several exclusivities to Sorilux. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sorilux, 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 Sorilux.
Exclusivity Information
Sorilux holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Sorilux's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Oct 06, 2013 |
| New Indication(I-657) | Sep 27, 2015 |
| New Patient Population(NPP) | Nov 05, 2022 |
US patents provide insights into the exclusivity only within the United States, but Sorilux 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 Sorilux's family patents as well as insights into ongoing legal events on those patents.
Sorilux's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sorilux's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 07, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sorilux Generic API suppliers:
Calcipotriene is the generic name for the brand Sorilux. 6 different companies have already filed for the generic of Sorilux, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sorilux's generic
Alternative Brands for Sorilux
Sorilux which is used for treating plaque psoriasis in patients aged 4 years and older., has several other brand drugs using the same active ingredient (Calcipotriene). 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 Calcipotriene, Sorilux's active ingredient. Check the complete list of approved generic manufacturers for Sorilux
About Sorilux
Sorilux is a drug owned by Mayne Pharma Llc. It is used for treating plaque psoriasis in patients aged 4 years and older. Sorilux uses Calcipotriene as an active ingredient. Sorilux was launched by Mayne Pharma in 2010.
Approval Date:
Sorilux was approved by FDA for market use on 06 October, 2010.
Active Ingredient:
Sorilux uses Calcipotriene as the active ingredient. Check out other Drugs and Companies using Calcipotriene ingredient
Treatment:
Sorilux is used for treating plaque psoriasis in patients aged 4 years and older.
Dosage:
Sorilux is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.005% | AEROSOL, FOAM | Prescription | TOPICAL |