Jatenzo is a drug owned by Tolmar Inc. It is protected by 10 US drug patents filed from 2019 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 12, 2039. Details of Jatenzo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10617696 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Apr, 2030
(5 years from now) | Active |
| US11179402 | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
Apr, 2026
(1 year, 4 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11564933 | Methods of treating testosterone deficiency |
Apr, 2039
(14 years from now) | Active |
| US8492369 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Dec, 2030
(6 years from now) | Active |
| US8778916 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Apr, 2030
(5 years from now) | Active |
| US11179403 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Apr, 2030
(5 years from now) | Active |
| US10543219 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Apr, 2030
(5 years from now) | Active |
| US11426416 | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
Apr, 2030
(5 years from now) | Active |
| US8241664 | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
Mar, 2029
(4 years from now) | Active |
| US11331325 | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
Jan, 2027
(2 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 Jatenzo's patents.
Latest Legal Activities on Jatenzo's Patents
Given below is the list of recent legal activities going on the following patents of Jatenzo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8241664 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 07 Feb, 2024 | US8241664 |
| Email Notification Critical | 25 Jan, 2024 | US11564933 |
| Email Notification Critical | 25 Jan, 2024 | US11426416 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Jan, 2024 | US11564933 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Jan, 2024 | US11426416 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 Jan, 2024 | US8241664 |
| Email Notification Critical | 23 Jan, 2024 | US8241664 |
| Email Notification Critical | 10 Jan, 2024 | US10543219 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Jan, 2024 | US11179403 |
FDA has granted several exclusivities to Jatenzo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jatenzo, 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 Jatenzo.
Exclusivity Information
Jatenzo holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Jatenzo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 27, 2022 |
Several oppositions have been filed on Jatenzo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Jatenzo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jatenzo patents.
Jatenzo's Oppositions Filed in EPO
Jatenzo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 26, 2023, by Aera A/S. This opposition was filed on patent number EP15186752A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP15186752A | Apr, 2023 | Aera A/S | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Jatenzo 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 Jatenzo's family patents as well as insights into ongoing legal events on those patents.
Jatenzo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jatenzo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 12, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jatenzo Generics:
There are no approved generic versions for Jatenzo as of now.
Alternative Brands for Jatenzo
Jatenzo which is used for treating testosterone deficiency in men., 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 | ||
|---|---|---|---|---|
| Besins Hlthcare |
| |||
| Eli Lilly And Co |
| |||
| Marius Pharms Llc |
| |||
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 Jatenzo
Jatenzo is a drug owned by Tolmar Inc. It is used for treating testosterone deficiency in men. Jatenzo uses Testosterone Undecanoate as an active ingredient. Jatenzo was launched by Tolmar in 2019.
Approval Date:
Jatenzo was approved by FDA for market use on 27 March, 2019.
Active Ingredient:
Jatenzo uses Testosterone Undecanoate as the active ingredient. Check out other Drugs and Companies using Testosterone Undecanoate ingredient
Treatment:
Jatenzo is used for treating testosterone deficiency in men.
Dosage:
Jatenzo is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 237MG | CAPSULE | Prescription | ORAL |
| 158MG | CAPSULE | Prescription | ORAL |
| 198MG | CAPSULE | Prescription | ORAL |