Soolantra is a drug owned by Galderma Laboratories Lp. It is protected by 14 US drug patents filed from 2015 to 2021. Out of these, 5 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 13, 2034. Details of Soolantra'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5952372 | Method for treating rosacea using oral or topical ivermectin |
Sep, 2018
(5 years ago) |
Expired
|
| US6133310 | Method of treatment of rosacea |
Apr, 2019
(5 years ago) |
Expired
|
| US8815816 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US8093219 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US8080530 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US8415311 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US11033565 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US7550440 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US8470788 | Topical application of ivermectin for the treatment of dermatological conditions/afflictions |
Apr, 2024
(3 months ago) |
Expired
|
| US9089587 | Treatment of papulopustular rosacea with ivermectin |
Mar, 2034
(9 years from now) | Active |
| US9233117 | Treatment of inflammatory lesions of rosacea with ivermectin |
Mar, 2034
(9 years from now) | Active |
| US10206939 | Treatment of papulopustular rosacea with ivermectin |
Mar, 2034
(9 years from now) | Active |
| US9782425 | Treatment of papulopustular rosacea with ivermectin |
Mar, 2034
(9 years from now) | Active |
| US9233118 | Treatment of papulopustular rosacea with ivermectin |
Mar, 2034
(9 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 Soolantra's patents.
Latest Legal Activities on Soolantra's Patents
Given below is the list of recent legal activities going on the following patents of Soolantra.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2023 | US9233117 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jul, 2023 | US9233118 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 03 Jul, 2023 | US8093219 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2023 | US8080530 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Jan, 2023 | US9089587 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Aug, 2022 | US10206939 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Feb, 2022 | US8815816 |
| Recordation of Patent Grant Mailed | 15 Jun, 2021 | US11033565 |
| Patent Issue Date Used in PTA Calculation | 15 Jun, 2021 | US11033565 |
| Email Notification | 27 May, 2021 | US11033565 |
FDA has granted several exclusivities to Soolantra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Soolantra, 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 Soolantra.
Exclusivity Information
Soolantra holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Soolantra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Dec 19, 2017 |
US patents provide insights into the exclusivity only within the United States, but Soolantra 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 Soolantra's family patents as well as insights into ongoing legal events on those patents.
Soolantra's family patents
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Generic Launch
Generic Release Date:
Soolantra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 13, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Soolantra Generics:
Ivermectin is the generic name for the brand Soolantra. 5 different companies have already filed for the generic of Soolantra, with Teva Pharms Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Soolantra's generic
How can I launch a generic of Soolantra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Soolantra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Soolantra'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 Soolantra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.01 | 30 Dec, 2016 | 1 | 13 Sep, 2019 | 13 Mar, 2034 | Eligible |
About Soolantra
Soolantra is a drug owned by Galderma Laboratories Lp. It is used for treating inflammatory lesions of rosacea. Soolantra uses Ivermectin as an active ingredient. Soolantra was launched by Galderma Labs Lp in 2014.
Market Authorisation Date:
Soolantra was approved by FDA for market use on 19 December, 2014.
Active Ingredient:
Soolantra uses Ivermectin as the active ingredient. Check out other Drugs and Companies using Ivermectin ingredient
Treatment:
Soolantra is used for treating inflammatory lesions of rosacea.
Dosage:
Soolantra is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Prescription | TOPICAL |