Last Updated: September 24, 2026

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 six 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 is one drug master file entry for this compound. Sixteen 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:	6

Medical Subject Heading (MeSH) Categories for 022504

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION, METERED;TRANSDERMAL			Strength	30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 23, 2010	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Feb 26, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
Patent:	⤷ Start Trial	Patent Expiration:	Sep 27, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
Patent:	⤷ Start Trial	Patent Expiration:	Feb 26, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.

Expired US Patents for NDA 022504

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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