Soolantra Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9233118 Treatment of papulopustular rosacea with ivermectin
Mar, 2034

(9 years from now)

Active
US10206939 Treatment of papulopustular rosacea with ivermectin
Mar, 2034

(9 years from now)

Active
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
US9782425 Treatment of papulopustular rosacea with ivermectin
Mar, 2034

(9 years from now)

Active
US8080530 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US8415311 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US11033565 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US8470788 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US7550440 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US8815816 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US8093219 Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Apr, 2024

(5 months ago)

Expired
US6133310 Method of treatment of rosacea
Apr, 2019

(5 years ago)

Expired
US5952372 Method for treating rosacea using oral or topical ivermectin
Sep, 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 Soolantra's patents.

Given below is the list of recent legal activities going on the following patents of Soolantra.

Activity Date Patent Number
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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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

Soolantra has patent protection in a total of 28 countries. It's US patent count contributes only to 34.7% of its total global patent coverage. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Soolantra.

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

Alternative Brands for Soolantra

Soolantra which is used for treating inflammatory lesions of rosacea., has several other brand drugs in the same treatment category and 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 Treatment Area
Journey
Zilxi Used for treating inflammatory lesions of rosacea.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ivermectin. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Arbor Pharms Llc
Sklice


Apart from brand drugs containing the same ingredient, some generics have also been filed for Ivermectin, Soolantra's active ingredient. Check the complete list of approved generic manufacturers for Soolantra





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.

Approval 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