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Baxter
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Chinese Patent Office
Express Scripts
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Generated: January 21, 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 eleven 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:11
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 0002-1975-90 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR
AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504 NDA Eli Lilly and Company 0002-1975 0002-1975-61 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0002-1975-61) > 90 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION, METERED;TRANSDERMALStrength30MG/1.5ML ACTUATION
Approval Date:Nov 23, 2010TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:➤ SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
Patent:➤ SubscribePatent Expiration:Feb 19, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS 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 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Deloitte
Harvard Business School
Mallinckrodt
Medtronic
Colorcon
Chubb
Argus Health

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