Topicort is a drug owned by Taro Pharmaceuticals Inc. It is protected by 3 US drug patents filed from 2013 to 2014. 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 Sep 01, 2028. Details of Topicort'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). | |||
| US8277780 | Stable liquid desoximethasone compositions with reduced oxidized impurity |
Sep, 2028
(3 years from now) | Active |
| US8715624 | Stable liquid desoximethasone compositions with reduced oxidized impurity |
May, 2026
(1 year, 5 months from now) | Active |
| US5990100 | Composition and method for treatment of psoriasis |
Mar, 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 Topicort's patents.
Latest Legal Activities on Topicort's Patents
Given below is the list of recent legal activities going on the following patents of Topicort.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Apr, 2024 | US8277780 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Nov, 2021 | US8715624 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Apr, 2020 | US8277780 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Oct, 2017 | US8715624 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 09 Mar, 2017 | US8715624 (Litigated) |
| Email Notification Critical | 09 Mar, 2017 | US8715624 (Litigated) |
| Email Notification Critical | 07 Mar, 2017 | US8277780 (Litigated) |
| Change in Power of Attorney (May Include Associate POA) Critical | 07 Mar, 2017 | US8277780 (Litigated) |
| Correspondence Address Change Critical | 07 Mar, 2017 | US8715624 (Litigated) |
| Correspondence Address Change Critical | 06 Mar, 2017 | US8277780 (Litigated) |
FDA has granted several exclusivities to Topicort. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Topicort, 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 Topicort.
Exclusivity Information
Topicort holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Topicort's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Apr 11, 2016 |
US patents provide insights into the exclusivity only within the United States, but Topicort 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 Topicort's family patents as well as insights into ongoing legal events on those patents.
Topicort's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Topicort's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 01, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Topicort Generic API suppliers:
Desoximetasone is the generic name for the brand Topicort. 16 different companies have already filed for the generic of Topicort, with Lupin having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Topicort's generic
How can I launch a generic of Topicort before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Topicort's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Topicort'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 Topicort -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0025 | 18 Dec, 2013 | 1 | 20 Jan, 2017 | 23 Apr, 2028 | Extinguished |
About Topicort
Topicort is a drug owned by Taro Pharmaceuticals Inc. It is used for treating plaque psoriasis in patients 18 years of age or older. Topicort uses Desoximetasone as an active ingredient. Topicort was launched by Taro in 2013.
Approval Date:
Topicort was approved by FDA for market use on 11 April, 2013.
Active Ingredient:
Topicort uses Desoximetasone as the active ingredient. Check out other Drugs and Companies using Desoximetasone ingredient
Treatment:
Topicort is used for treating plaque psoriasis in patients 18 years of age or older.
Dosage:
Topicort is available in spray form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25% | SPRAY | Prescription | TOPICAL |