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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-type	Androstanes
Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 022504

Androgens

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:	DISCN	Dosage:	SOLUTION, METERED;TRANSDERMAL			Strength	30MG/1.5ML ACTUATION
Approval Date:	Nov 23, 2010	TE:		RLD:	Yes
Patent:	➤ Sign Up	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:	➤ Sign Up	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:	➤ Sign Up	Patent Expiration:	Jul 13, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE

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	➤ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.