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Last Updated: November 26, 2020

DrugPatentWatch Database Preview

AXIRON Drug 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in fifteen countries.

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

US ANDA 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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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
INC ResearchPhase 3
Eli Lilly and CompanyPhase 1

See all AXIRON clinical trials

Paragraph IV (Patent) Challenges for AXIRON
Tradename Dosage Ingredient NDA Submissiondate
AXIRON SOLUTION, METERED;TRANSDERMAL testosterone 022504 2013-01-29

US Patents and Regulatory Information for AXIRON

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   Start Trial   Start Trial   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010   Start Trial   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010   Start Trial   Start Trial
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AXIRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1769785 CA 2012 00012 Denmark   Start Trial
1769785 91972 Luxembourg   Start Trial 91972, EXPIRES: 20220219
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1769785 C300522 Netherlands   Start Trial 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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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Boehringer Ingelheim
Baxter
Medtronic
AstraZeneca

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