Onmel is a drug owned by Sebela Ireland Ltd. It is protected by 4 US drug patents filed in 2013. Out of these, 1 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 03, 2028. Details of Onmel'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). | |||
| US8486456 | Itraconazole compositions with improved bioavailability |
Oct, 2028
(2 years from now) | Active |
| US8591948 | Antifungal compositions with improved bioavailability |
May, 2017
(9 years ago) |
Expired
|
| US6509038 | Antifungal compositions with improved bioavailability |
May, 2017
(9 years ago) |
Expired
|
| US7081255 | Antifungal compositions with improved bioavailability |
May, 2017
(9 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 Onmel's patents.
Latest Legal Activities on Onmel's Patents
Given below is the list of recent legal activities going on the following patents of Onmel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 29 Dec, 2025 | US8591948 |
| Maintenance Fee Reminder Mailed | 14 Jul, 2025 | US8591948 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Dec, 2024 | US8486456 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 May, 2021 | US8591948 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Dec, 2020 | US8486456 |
| Expire Patent
Critical | 27 Aug, 2018 | US7081255 |
| Maintenance Fee Reminder Mailed
Critical | 05 Mar, 2018 | US7081255 |
| Post Issue Communication - Certificate of Correction | 30 Apr, 2014 | US8486456 |
| Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 20 Mar, 2014 | US8486456 |
| Mail-Record a Petition Decision of Granted to Issue Patent in Name of the Assignee | 20 Mar, 2014 | US8486456 |
FDA has granted several exclusivities to Onmel. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Onmel, 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
Onmel.
Exclusivity Information
Onmel holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Onmel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 29, 2013 |
US patents provide insights into the exclusivity only within the United States, but
Onmel 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 Onmel's family patents as well as insights into
ongoing legal events
on those patents.
Onmel's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Onmel:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Onmel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 03, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Onmel Generic API suppliers:
Itraconazole is the generic name for the brand Onmel. 13 different companies have already filed for the generic of Onmel, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Onmel's generic
Alternative Brands for Onmel
Onmel which is used for treating onychomycosis of the toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes., has several other brand drugs using the same active ingredient (Itraconazole). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Itraconazole, Onmel's active ingredient. Check the complete list of approved generic manufacturers for Onmel
About Onmel
Onmel is a drug owned by Sebela Ireland Ltd. It is used for treating onychomycosis of the toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes. Onmel uses Itraconazole as an active ingredient. Onmel was launched by Sebela in 2010.
Approval Date:
Onmel was approved by FDA for market use on 29 April, 2010.
Active Ingredient:
Onmel uses Itraconazole as the active ingredient. Check out other Drugs and Companies using Itraconazole ingredient
Treatment:
Onmel is used for treating onychomycosis of the toenail caused by Trichophyton rubrum or Trichophyton mentagrophytes.
Dosage:
Onmel is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Discontinued | ORAL |