Tolsura is a drug owned by Mayne Pharma International Pty Ltd. It is protected by 6 US drug patents filed from 2018 to 2021. Out of these, 5 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2033. Details of Tolsura'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). | |||
| US10463740 | Itraconazole compositions and dosage forms, and methods of using the same |
Jun, 2033
(6 years from now) | Active |
| US9713642 | Itraconazole compositions and dosage forms, and methods of using the same |
Jun, 2033
(6 years from now) | Active |
| US10806792 | Itraconazole compositions and dosage forms, and methods of using the same |
Jun, 2033
(6 years from now) | Active |
| US8921374 | Itraconazole compositions and dosage forms, and methods of using the same |
Jun, 2033
(6 years from now) | Active |
| US9272046 | Itraconazole compositions and dosage forms, and methods of using the same |
Jun, 2033
(6 years from now) | Active |
| US8771739 | Pharmaceutical compositions for poorly soluble drugs |
Jul, 2023
(3 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 Tolsura's patents.
Latest Legal Activities on Tolsura's Patents
Given below is the list of recent legal activities going on the following patents of Tolsura.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Jan, 2026 | US8771739 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Jan, 2025 | US9713642 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Apr, 2024 | US10806792 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Aug, 2023 | US9272046 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Apr, 2023 | US10463740 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 May, 2022 | US8921374 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 28 Apr, 2022 | US8921374 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Dec, 2021 | US8771739 |
| Recordation of Patent Grant Mailed
Critical | 20 Oct, 2020 | US10806792 |
| Patent Issue Date Used in PTA Calculation
Critical | 20 Oct, 2020 | US10806792 |
US patents provide insights into the exclusivity only within the United States, but
Tolsura 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 Tolsura's family patents as well as insights into
ongoing legal events
on those patents.
Tolsura's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Tolsura:
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:
Tolsura's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 21, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tolsura Generic API suppliers:
Itraconazole is the generic name for the brand Tolsura. 13 different companies have already filed for the generic of Tolsura, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tolsura's generic
Alternative Brands for Tolsura
Tolsura which is used for treating fungal infections including blastomycosis, histoplasmosis, and aspergillosis., 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, Tolsura's active ingredient. Check the complete list of approved generic manufacturers for Tolsura
About Tolsura
Tolsura is a drug owned by Mayne Pharma International Pty Ltd. It is used for treating fungal infections including blastomycosis, histoplasmosis, and aspergillosis. Tolsura uses Itraconazole as an active ingredient. Tolsura was launched by Mayne in 2018.
Approval Date:
Tolsura was approved by FDA for market use on 11 December, 2018.
Active Ingredient:
Tolsura uses Itraconazole as the active ingredient. Check out other Drugs and Companies using Itraconazole ingredient
Treatment:
Tolsura is used for treating fungal infections including blastomycosis, histoplasmosis, and aspergillosis.
Dosage:
Tolsura is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 65MG | CAPSULE | Prescription | ORAL |