Axiron Patent Expiration

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, 7 months from now)

Active
US8993520 Method and composition for transdermal drug delivery
Jun, 2026

(1 year, 7 months from now)

Active
US8784878 Transdermal delivery rate control using amorphous pharmaceutical compositions
Jul, 2023

(1 year, 3 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.

Given below is the list of recent legal activities going on the following patents of Axiron.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 07 Feb, 2022 US8807861
Expire Patent 14 Jun, 2021 US8435944
Maintenance Fee Reminder Mailed 28 Dec, 2020 US8435944
Payment of Maintenance Fee, 8th Year, Large Entity 06 Jul, 2020 US8419307
Expire Patent 13 Jan, 2020 US8071075
Maintenance Fee Reminder Mailed 29 Jul, 2019 US8071075
Notice of Final Determination -Election Required 09 Jan, 2019 US6818226
Change in Power of Attorney (May Include Associate POA) 02 Oct, 2018 US8807861
Email Notification 02 Oct, 2018 US8807861
Correspondence Address Change 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

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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
Patent litigations
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

Axiron has patent protection in a total of 15 countries. It's US patent count contributes only to 25.8% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Axiron.

Family Patents

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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 Generics:

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.

Drug Owner Drug Name Treatment Area
Besins Hlthcare
Androgel

(uses Testosterone)

Used for treating conditions associated with a deficiency or absence of endogenous testosterone in males.
Tolmar
Jatenzo

(uses Testosterone)

Used for treating testosterone deficiency in men.

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
Natesto
Alza
Testoderm
Testoderm Tts
Antares Pharma Inc
Xyosted (autoinjector)
Auxilium Pharms Llc
Striant
Azurity
Testosterone Cypionate
Endo Operations
Aveed
Fortesta
Testim
Marius Pharms Llc
Kyzatrex
Upsher Smith Labs
Vogelxo
Verity
Tlando


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