Testim is a drug owned by Endo Operations Ltd. It is protected by 10 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 18, 2025. Details of Testim'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). | |||
| US7320968 | Pharmaceutical composition |
Jan, 2025
(1 year, 8 months ago) |
Expired
|
| US7608608 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7608609 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US8063029 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7608607 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7608610 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7608605 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7935690 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US8178518 | Pharmaceutical composition |
Apr, 2023
(3 years ago) |
Expired
|
| US7608606 | Pharmaceutical composition |
Apr, 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 Testim's patents.
Latest Legal Activities on Testim's Patents
Given below is the list of recent legal activities going on the following patents of Testim.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 17 Jun, 2024 | US8178518 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 01 Jan, 2024 | US8178518 (Litigated) |
| Expire Patent
Critical | 25 Dec, 2023 | US8063029 |
| Maintenance Fee Reminder Mailed
Critical | 10 Jul, 2023 | US8063029 |
| Expire Patent
Critical | 05 Jun, 2023 | US7935690 (Litigated) |
| Maintenance Fee Reminder Mailed
Critical | 19 Dec, 2022 | US7935690 (Litigated) |
| Expire Patent
Critical | 29 Nov, 2021 | US7608609 (Litigated) |
| Expire Patent
Critical | 29 Nov, 2021 | US7608606 (Litigated) |
| Expire Patent
Critical | 29 Nov, 2021 | US7608607 (Litigated) |
| Expire Patent
Critical | 29 Nov, 2021 | US7608605 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but
Testim 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 Testim's family patents as well as insights into
ongoing legal events
on those patents.
Testim's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Testim:
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:
Testim's generic launch date based on the expiry of its last outstanding patent is estimated to be Jan 18, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Testim Generic API suppliers:
Testosterone is the generic name for the brand Testim. 14 different companies have already filed for the generic of Testim, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Testim's generic
How can I launch a generic of Testim before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Testim's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Testim's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Testim -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 21 Aug, 2008 | 11 Jun, 2008 | Extinguished | Less |
Alternative Brands for Testim
Testim which is used for testosterone replacement therapy., has several other brand drugs using the same active ingredient (Testosterone). 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 | ||
|---|---|---|---|
| Acerus |
| ||
| Alza |
| ||
| Antares Pharma Inc |
| ||
| Auxilium Pharms Llc |
| ||
| Azurity |
| ||
| Besins Hlthcare |
| ||
| Eli Lilly And Co |
| ||
| Endo Operations |
| ||
| Marius |
| ||
| Tolmar |
| ||
| Upsher Smith Labs |
| ||
| Verity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Testim's active ingredient. Check the complete list of approved generic manufacturers for Testim
About Testim
Testim is a drug owned by Endo Operations Ltd. It is used for testosterone replacement therapy. Testim uses Testosterone as an active ingredient. Testim was launched by Endo Operations in 2002.
Approval Date:
Testim was approved by FDA for market use on 31 October, 2002.
Active Ingredient:
Testim uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient
Treatment:
Testim is used for testosterone replacement therapy.
Dosage:
Testim is available in gel form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG/5GM PACKET | GEL | Prescription | TRANSDERMAL |