Axiron is a drug owned by Eli Lilly And Co. It is protected by 11 US drug patents filed from 2013 to 2016. Out of these, 6 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 27, 2027. Details of Axiron'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). | |||
| US8435944 | Method and composition for transdermal drug delivery |
Sep, 2027
(2 years from now) | Active |
| US8419307 | Spreading implement |
Feb, 2027
(2 years from now) | Active |
| US8807861 | Spreading implement |
Feb, 2027
(2 years from now) | Active |
| US9289586 | Spreading implement |
Feb, 2027
(2 years from now) | Active |
| US9180194 | Method and composition for transdermal drug delivery |
Jun, 2026
(1 year, 6 months from now) | Active |
| US8993520 | Method and composition for transdermal drug delivery |
Jun, 2026
(1 year, 6 months from now) | Active |
| US8784878 | Transdermal delivery rate control using amorphous pharmaceutical compositions |
Jul, 2023
(1 year, 4 months ago) |
Expired
|
| US6923983 | Transdermal delivery of hormones |
Feb, 2017
(7 years ago) |
Expired
|
| US6299900 | Dermal penetration enhancers and drug delivery systems involving same |
Feb, 2017
(7 years ago) |
Expired
|
| US8071075 | Dermal penetration enhancers and drug delivery systems involving the same |
Feb, 2017
(7 years ago) |
Expired
|
| US6818226 | Dermal penetration enhancers and drug delivery systems involving same |
Feb, 2017
(7 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 Axiron's patents.
Latest Legal Activities on Axiron's Patents
Given below is the list of recent legal activities going on the following patents of Axiron.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2022 | US8807861 |
| Expire Patent Critical | 14 Jun, 2021 | US8435944 |
| Maintenance Fee Reminder Mailed Critical | 28 Dec, 2020 | US8435944 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jul, 2020 | US8419307 |
| Expire Patent Critical | 13 Jan, 2020 | US8071075 |
| Maintenance Fee Reminder Mailed Critical | 29 Jul, 2019 | US8071075 |
| Notice of Final Determination -Election Required | 09 Jan, 2019 | US6818226 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Oct, 2018 | US8807861 |
| Email Notification Critical | 02 Oct, 2018 | US8807861 |
| Correspondence Address Change Critical | 01 Oct, 2018 | US8807861 |
FDA has granted several exclusivities to Axiron. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Axiron, 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 Axiron.
Exclusivity Information
Axiron holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Axiron's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 23, 2013 |
Several oppositions have been filed on Axiron'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 Axiron's generic, the next section provides detailed information on ongoing and past EP oppositions related to Axiron patents.
Axiron's Oppositions Filed in EPO
Axiron has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 26, 2017, by Müller Fottner Steinecke Rechtsanwalts- Und Patentanwaltspartnerschaft Mbb. This opposition was filed on patent number EP03729716A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06741180A | Aug, 2017 | Müller Fottner Steinecke Rechtsanwalts- und Patentanwaltspartnerschaft mbB | Revoked |
| EP03729716A | Apr, 2017 | Müller Fottner Steinecke Rechtsanwalts- und Patentanwaltspartnerschaft mbB | Revoked |
US patents provide insights into the exclusivity only within the United States, but Axiron 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 Axiron's family patents as well as insights into ongoing legal events on those patents.
Axiron's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Axiron's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 27, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Axiron Generic API suppliers:
Testosterone is the generic name for the brand Axiron. 15 different companies have already filed for the generic of Axiron, 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 Axiron's generic
How can I launch a generic of Axiron before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Axiron's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Axiron'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 Axiron -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg/1.5 mL | 29 Jan, 2013 | 1 | 07 Aug, 2017 | 19 Feb, 2017 | Extinguished |
Alternative Brands for Axiron
Axiron which is used for treating conditions associated with a deficiency or absence of endogenous testosterone., 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.
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 Pharms Llc |
| |||
| Upsher Smith Labs |
| |||
| Verity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Testosterone, Axiron's active ingredient. Check the complete list of approved generic manufacturers for Axiron
About Axiron
Axiron is a drug owned by Eli Lilly And Co. It is used for treating conditions associated with a deficiency or absence of endogenous testosterone. Axiron uses Testosterone as an active ingredient. Axiron was launched by Eli Lilly And Co in 2010.
Approval Date:
Axiron was approved by FDA for market use on 23 November, 2010.
Active Ingredient:
Axiron uses Testosterone as the active ingredient. Check out other Drugs and Companies using Testosterone ingredient
Treatment:
Axiron is used for treating conditions associated with a deficiency or absence of endogenous testosterone.
Dosage:
Axiron is available in solution, metered form for transdermal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION, METERED | Discontinued | TRANSDERMAL |