Ciclopirox is a drug owned by Alvogen Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2018. Details of Ciclopirox'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). | |||
| US7018656 | Antimycotic gel with high active substance release |
Sep, 2018
(6 years ago) |
Expired
|
| US7026337 | Antimycotic gel having high active compound release |
Nov, 2016
(8 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 Ciclopirox's patents.
Latest Legal Activities on Ciclopirox's Patents
Given below is the list of recent legal activities going on the following patents of Ciclopirox.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 07 May, 2018 | US7026337 |
| Maintenance Fee Reminder Mailed Critical | 20 Nov, 2017 | US7026337 |
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Mar, 2009 | US7026337 |
| Correspondence Address Change Critical | 24 Mar, 2009 | US7026337 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Sep, 2007 | US7026337 |
| Recordation of Patent Grant Mailed Critical | 11 Apr, 2006 | US7026337 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Apr, 2006 | US7026337 |
| Issue Notification Mailed Critical | 22 Mar, 2006 | US7026337 |
| Dispatch to FDC | 09 Mar, 2006 | US7026337 |
| Application Is Considered Ready for Issue Critical | 27 Jan, 2006 | US7026337 |
US patents provide insights into the exclusivity only within the United States, but Ciclopirox 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 Ciclopirox's family patents as well as insights into ongoing legal events on those patents.
Ciclopirox's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ciclopirox's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 05, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ciclopirox Generic API suppliers:
Ciclopirox is the generic name for the brand Ciclopirox. 17 different companies have already filed for the generic of Ciclopirox, with Fougera Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ciclopirox's generic
How can I launch a generic of Ciclopirox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ciclopirox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ciclopirox'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 Ciclopirox -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0077 | 10 May, 2006 | 1 | 07 Jan, 2009 | 05 Sep, 2018 | Extinguished |
Alternative Brands for Ciclopirox
Ciclopirox which is used for treating interdigital tinea pedis and tinea corporis caused by certain types of fungi., has several other brand drugs using the same active ingredient (Ciclopirox). 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 | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ciclopirox, Ciclopirox's active ingredient. Check the complete list of approved generic manufacturers for Ciclopirox
About Ciclopirox
Ciclopirox is a drug owned by Alvogen Inc. It is used for treating interdigital tinea pedis and tinea corporis caused by certain types of fungi. Ciclopirox uses Ciclopirox as an active ingredient. Ciclopirox was launched by Alvogen in 1997.
Approval Date:
Ciclopirox was approved by FDA for market use on 21 July, 1997.
Active Ingredient:
Ciclopirox uses Ciclopirox as the active ingredient. Check out other Drugs and Companies using Ciclopirox ingredient
Treatment:
Ciclopirox is used for treating interdigital tinea pedis and tinea corporis caused by certain types of fungi.
Dosage:
Ciclopirox is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Discontinued | TOPICAL |