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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Moodys
Queensland Health
Harvard Business School
US Army
Johnson and Johnson
QuintilesIMS
Mallinckrodt

Generated: June 23, 2018

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. It is available from three suppliers. 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-three drug master file entries for this compound. Nineteen 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 022504
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 022504
Suppliers and Packaging for NDA: 022504
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504 NDA Eli Lilly and Company 0002-1975 N 0002-1975-61
AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504 NDA Eli Lilly and Company 0002-1975 N 0002-1975-90

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION, METERED;TRANSDERMALStrength30MG/1.5ML ACTUATION
Approval Date:Nov 23, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
Patent:➤ Sign UpPatent Expiration:Sep 27, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Patent:➤ Sign UpPatent Expiration:Jul 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE

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 ➤ 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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Deloitte
Cerilliant
QuintilesIMS
Mallinckrodt
Accenture
Covington
Citi
Chubb

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