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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021454

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NDA 021454 describes TESTIM, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from three suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TESTIM profile page.

The generic ingredient in TESTIM is testosterone. There are sixty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 021454
Tradename:TESTIM
Applicant:Auxilium Pharms Llc
Ingredient:testosterone
Patents:10
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 021454
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 021454
Suppliers and Packaging for NDA: 021454
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTIM testosterone GEL;TRANSDERMAL 021454 NDA Physicians Total Care, Inc. 54868-4989 E 54868-4989-0
TESTIM testosterone GEL;TRANSDERMAL 021454 NDA Endo Pharmaceuticals, Inc. 66887-001 N 66887-001-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Oct 31, 2002TE:AB2RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 18, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR ADMINISTRATION OF TESTOSTERONE
Patent:➤ Sign UpPatent Expiration:Apr 21, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR ADMINISTRATION OF TESTOSTERONE
Patent:➤ Sign UpPatent Expiration:Apr 21, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD FOR ADMINISTRATION OF TESTOSTERONE

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fuji
Chubb
QuintilesIMS
Julphar
Daiichi Sankyo
US Department of Justice
Covington
Harvard Business School

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