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Last Updated: November 30, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022504

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NDA 022504 describes AXIRON, which 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. Additional details are available on the AXIRON profile page.

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.
Summary for 022504
Tradename:AXIRON
Applicant:Eli Lilly And Co
Ingredient:testosterone
Patents:7
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022504
Paragraph IV (Patent) Challenges for 022504
Tradename Dosage Ingredient NDA Submissiondate
AXIRON SOLUTION, METERED;TRANSDERMAL testosterone 022504 2013-01-29

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION, METERED;TRANSDERMALStrength30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 23, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 26, 2027Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 27, 2027Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jul 13, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022504

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

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