Xolegel is a drug owned by Almirall Llc. It is protected by 3 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 24, 2020. Details of Xolegel'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). | |||
| US8232276 | Anhydrous topical skin preparations |
Nov, 2020
(3 years ago) |
Expired
|
| US8735393 | Anhydrous topical skin preparations |
Dec, 2018
(5 years ago) |
Expired
|
| US7179475 | Anhydrous topical skin preparations |
Dec, 2018
(5 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 Xolegel's patents.
Latest Legal Activities on Xolegel's Patents
Given below is the list of recent legal activities going on the following patents of Xolegel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 18 Mar, 2024 | US8232276 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Dec, 2019 | US8232276 |
| Post Issue Communication - Certificate of Correction | 15 Oct, 2012 | US8232276 |
| Recordation of Patent Grant Mailed Critical | 31 Jul, 2012 | US8232276 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Jul, 2012 | US8232276 |
| Issue Notification Mailed Critical | 11 Jul, 2012 | US8232276 |
| Dispatch to FDC | 28 Jun, 2012 | US8232276 |
| Application Is Considered Ready for Issue Critical | 28 Jun, 2012 | US8232276 |
| Issue Fee Payment Verified Critical | 27 Jun, 2012 | US8232276 |
| Issue Fee Payment Received Critical | 27 Jun, 2012 | US8232276 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Xolegel and ongoing litigations to help you estimate the early arrival of Xolegel generic.
Xolegel's Litigations
Xolegel been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 22, 2009, against patent number US8232276. The petitioner , challenged the validity of this patent, with Katherine M. Burnett et al as the respondent. Click below to track the latest information on how companies are challenging Xolegel's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8232276 | June, 2009 |
Decision
(17 May, 2010) | Katherine M. Burnett et al | |
US patents provide insights into the exclusivity only within the United States, but Xolegel 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 Xolegel's family patents as well as insights into ongoing legal events on those patents.
Xolegel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xolegel's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 24, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xolegel Generic API suppliers:
Ketoconazole is the generic name for the brand Xolegel. 17 different companies have already filed for the generic of Xolegel, with Teva having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xolegel's generic
Alternative Brands for Xolegel
Xolegel which is used for treating seborrheic dermatitis in humans., has several other brand drugs using the same active ingredient (Ketoconazole). 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 | |
|---|---|---|
| Kramer |
| |
| Norvium Bioscience |
| |
| Strongbridge |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ketoconazole, Xolegel's active ingredient. Check the complete list of approved generic manufacturers for Xolegel
About Xolegel
Xolegel is a drug owned by Almirall Llc. It is used for treating seborrheic dermatitis in humans. Xolegel uses Ketoconazole as an active ingredient. Xolegel was launched by Almirall in 2006.
Approval Date:
Xolegel was approved by FDA for market use on 28 July, 2006.
Active Ingredient:
Xolegel uses Ketoconazole as the active ingredient. Check out other Drugs and Companies using Ketoconazole ingredient
Treatment:
Xolegel is used for treating seborrheic dermatitis in humans.
Dosage:
Xolegel is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | GEL | Discontinued | TOPICAL |