Androgel is a drug owned by Besins Healthcare Ireland Ltd. It is protected by 15 US drug patents filed from 2013 to 2016. Out of these, 9 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 12, 2026. Details of Androgel'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). | |||
| US8466137 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8754070 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8466136 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8729057 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8466138 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8486925 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8759329 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8741881 | Testosterone gel and method of use |
Oct, 2026
(8 hours from now) | Active |
| US8446138 | Stability compensation circuit and DC-DC converter including the same |
Oct, 2026
(8 hours from now) | Active |
|
US9132089 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar, 2021
(5 years ago) |
Expired
|
|
US9125816 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar, 2021
(5 years ago) |
Expired
|
|
US6503894 (Pediatric) | Pharmaceutical composition and method for treating hypogonadism |
Mar, 2021
(5 years ago) |
Expired
|
| US6503894 | Pharmaceutical composition and method for treating hypogonadism |
Aug, 2020
(6 years ago) |
Expired
|
| US9132089 | Pharmaceutical composition and method for treating hypogonadism |
Aug, 2020
(6 years ago) |
Expired
|
| US9125816 | Pharmaceutical composition and method for treating hypogonadism |
Aug, 2020
(6 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 Androgel's patents.
Latest Legal Activities on Androgel's Patents
Given below is the list of recent legal activities going on the following patents of Androgel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Nov, 2025 | US8754070 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Nov, 2025 | US8759329 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Nov, 2025 | US8741881 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Oct, 2025 | US8729057 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Dec, 2024 | US8486925 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Nov, 2024 | US8466138 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Nov, 2024 | US8466137 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Nov, 2024 | US8466136 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Nov, 2024 | US8446138 |
| Expire Patent
Critical | 23 Oct, 2023 | US9132089 (Litigated) |
FDA has granted several exclusivities to Androgel. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Androgel, 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
Androgel.
Exclusivity Information
Androgel holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Androgel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 29, 2014 |
Several oppositions have been filed on Androgel'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 Androgel's generic, the next section provides detailed information on
ongoing and past
EP oppositions related to Androgel patents.
Androgel's Oppositions Filed in EPO
Androgel has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 21, 2013, by Oser, Andreas. This opposition was filed on patent number EP06836341A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06836341A | Aug, 2013 | Oser, Andreas | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but
Androgel 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 Androgel's family patents as well as insights into
ongoing legal events
on those patents.
Androgel's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Androgel:
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:
Androgel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 12, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Androgel Generic API suppliers:
Testosterone is the generic name for the brand Androgel. 14 different companies have already filed for the generic of Androgel, 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 Androgel's generic
How can I launch a generic of Androgel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Androgel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Androgel'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 Androgel -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 19 Jun, 2013 | 12 Oct, 2026 | Deferred | 12 Jul, 2017 | Less |
Alternative Brands for Androgel
Androgel which is used for treating conditions associated with a deficiency or absence of endogenous testosterone in males., has several other brand drugs in the same treatment category and 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 | Treatment Area | ||
|---|---|---|---|---|
| Eli Lilly And Co |
| |||
| Endo Operations |
| |||
| 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. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Acerus |
| ||
| Alza |
| ||
| Antares Pharma Inc |
| ||
| Auxilium Pharms Llc |
| ||
| Azurity |
| ||
| Endo Operations |
| ||
| Marius |
| ||
| Upsher Smith Labs |
| ||
| Verity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Androgel's active ingredient. Check the complete list of approved generic manufacturers for Androgel
About Androgel
Androgel is a drug owned by Besins Healthcare Ireland Ltd. It is used for treating conditions associated with a deficiency or absence of endogenous testosterone in males. Androgel uses Testosterone as an active ingredient. Androgel was launched by Besins in 2011.
Approval Date:
Androgel was approved by FDA for market use on 29 April, 2011.
Active Ingredient:
Androgel uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient
Treatment:
Androgel is used for treating conditions associated with a deficiency or absence of endogenous testosterone in males.
Dosage:
Androgel is available in the following dosage forms - gel form for transdermal use, gel, metered form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Prescription | TRANSDERMAL |
| 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED | Prescription | TRANSDERMAL |
| 1.62% (20.25MG/1.25GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Prescription | TRANSDERMAL |
| 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL, METERED | Prescription | TRANSDERMAL |
| 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Prescription | TRANSDERMAL |
| 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL | Prescription | TRANSDERMAL |