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Last Updated: November 21, 2024

AXIRON Drug Patent Profile


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Which patents cover Axiron, and when can generic versions of Axiron launch?

Axiron is a drug marketed by Eli Lilly And Co and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in fifteen countries.

The generic ingredient in AXIRON is testosterone. There are sixty-nine drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Axiron

A generic version of AXIRON was approved as testosterone by ACTAVIS LABS UT INC on January 27th, 2006.

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Summary for AXIRON
Drug patent expirations by year for AXIRON
Drug Prices for AXIRON

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Drug Sales Revenue Trends for AXIRON

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Recent Clinical Trials for AXIRON

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Clarus Therapeutics, Inc.Phase 3
Syneos HealthPhase 3
INC ResearchPhase 3

See all AXIRON clinical trials

Paragraph IV (Patent) Challenges for AXIRON
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AXIRON Topical Solution testosterone 30 mg/1.5 mL 022504 1 2013-01-29

US Patents and Regulatory Information for AXIRON

AXIRON is protected by six US patents.

Patents protecting AXIRON

Spreading implement
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF

Method and composition for transdermal drug delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF

Spreading implement
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.

Method and composition for transdermal drug delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF

Method and composition for transdermal drug delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF

Spreading implement
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AXIRON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ⤷  Sign Up ⤷  Sign Up
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AXIRON

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Warner Chilcott UK Ltd. Intrinsa testosterone EMEA/H/C/000634
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
Warner Chilcott  Deutschland GmbH Livensa testosterone EMEA/H/C/000630
Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Withdrawn no no no 2006-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AXIRON

See the table below for patents covering AXIRON around the world.

Country Patent Number Title Estimated Expiration
South Korea 20050045946 TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
Eurasian Patent Organization 015473 ИНСТРУМЕНТ ДЛЯ НАНЕСЕНИЯ ОБЪЕМА ЖИДКОСТИ НА ОБРАБАТЫВАЕМУЮ ПОВЕРХНОСТЬ, СИСТЕМА И СПОСОБ ТРАНСДЕРМАЛЬНОГО ВВЕДЕНИЯ ФИЗИОЛОГИЧЕСКИ АКТИВНОГО ВЕЩЕСТВА В ОРГАНИЗМ БОЛЬНОГО (IMPLEMENT FOR APPLYING A VOLUME OF LIQUID TO A TREATED SURFACE, SYSTEM AND METHOD FOR TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICAL ACTIVE AGENT INTO A SUBJECT) ⤷  Sign Up
European Patent Office 1534235 COMMANDE DE DEBIT D'APPORT TRANSDERMIQUE UTILISANT DES COMPOSITIONS PHARMACEUTIQUES AMORPHES (TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
Mexico 2009007366 IMPLEMENTO PARA UNTAR. (SPREADING IMPLEMENT.) ⤷  Sign Up
South Korea 20100055542 TRANSDERMAL DELIVERY RATE CONTROL USING AMORPHOUS PHARMACEUTICAL COMPOSITIONS ⤷  Sign Up
Germany 122012000019 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AXIRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 91972 Luxembourg ⤷  Sign Up 91972, EXPIRES: 20220219
1769785 CA 2012 00011 Denmark ⤷  Sign Up
1769785 91971 Luxembourg ⤷  Sign Up 91971, EXPIRES: 20220219
0901368 CA 2012 00010 Denmark ⤷  Sign Up
0901368 91973 Luxembourg ⤷  Sign Up 91973, EXPIRES: 20220219
1769785 C300522 Netherlands ⤷  Sign Up PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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