Kyzatrex is a drug owned by Marius Pharmaceuticals Inc. It is protected by 6 US drug patents filed from 2022 to 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 29, 2041. Details of Kyzatrex'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). | |||
| US12403146 | NA |
Mar, 2041
(15 years from now) | Active |
| US11617758 | Emulsion formulations |
Mar, 2033
(7 years from now) | Active |
| US12357643 | NA |
Mar, 2033
(7 years from now) | Active |
| US10576089 | Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols |
Dec, 2030
(5 years from now) | Active |
| US11590146 | Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols |
Dec, 2030
(5 years from now) | Active |
| US10576090 | Modulation of solubility, stability, absorption, metabolism, and pharmacokinetic profile of lipophilic drugs by sterols |
Dec, 2030
(5 years from now) | Active |
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 Kyzatrex's patents.
Latest Legal Activities on Kyzatrex's Patents
Given below is the list of recent legal activities going on the following patents of Kyzatrex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 05 Sep, 2023 | US10576090 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 01 Sep, 2023 | US10576089 |
| Recordation of Patent Grant Mailed
Critical | 04 Apr, 2023 | US11617758 |
| Patent Issue Date Used in PTA Calculation
Critical | 04 Apr, 2023 | US11617758 |
| Email Notification
Critical | 16 Mar, 2023 | US11617758 |
| Issue Notification Mailed
Critical | 15 Mar, 2023 | US11617758 |
| Recordation of Patent Grant Mailed
Critical | 28 Feb, 2023 | US11590146 |
| Patent Issue Date Used in PTA Calculation
Critical | 28 Feb, 2023 | US11590146 |
| Email Notification
Critical | 28 Feb, 2023 | US11590146 |
| Application Is Considered Ready for Issue
Critical | 24 Feb, 2023 | US11617758 |
FDA has granted several exclusivities to Kyzatrex. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Kyzatrex, 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
Kyzatrex.
Exclusivity Information
Kyzatrex holds 1 exclusivities. All of its exclusivities have expired in 2025. Details of Kyzatrex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 27, 2025 |
US patents provide insights into the exclusivity only within the United States, but
Kyzatrex 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 Kyzatrex's family patents as well as insights into
ongoing legal events
on those patents.
Kyzatrex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kyzatrex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 29, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kyzatrex Generics:
There are no approved generic versions for Kyzatrex as of now.
Alternative Brands for Kyzatrex
Kyzatrex which is used for treating testosterone deficiency., has several other brand drugs in the same treatment category and using the same active ingredient (Testosterone Undecanoate). 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 | Treatment Area | ||
|---|---|---|---|---|
| Tolmar |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Testosterone Undecanoate. Given below is the list of those drugs and companies owning them.
About Kyzatrex
Kyzatrex is a drug owned by Marius Pharmaceuticals Inc. It is used for treating testosterone deficiency. Kyzatrex uses Testosterone Undecanoate as an active ingredient. Kyzatrex was launched by Marius in 2022.
Approval Date:
Kyzatrex was approved by FDA for market use on 27 July, 2022.
Active Ingredient:
Kyzatrex uses Testosterone Undecanoate as the active ingredient. Check out other Drugs and Companies using Testosterone Undecanoate ingredient
Treatment:
Kyzatrex is used for treating testosterone deficiency.
Dosage:
Kyzatrex is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Discontinued | ORAL |
| 200MG | CAPSULE | Prescription | ORAL |
| 150MG | CAPSULE | Prescription | ORAL |