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Last Updated: July 3, 2020

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 two 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-nine 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 021454
Tradename:TESTIM
Applicant:Auxilium Pharms Llc
Ingredient:testosterone
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 021454
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 AUTHORIZED GENERIC Par Pharmaceutical, Inc. 0254-1012 0254-1012-11 30 TUBE in 1 CARTON (0254-1012-11) > 5 g in 1 TUBE
TESTIM testosterone GEL;TRANSDERMAL 021454 NDA Endo Pharmaceuticals, Inc. 66887-001 66887-001-05 30 TUBE in 1 CARTON (66887-001-05) > 5 g in 1 TUBE
Paragraph IV (Patent) Challenges for 021454
Tradename Dosage Ingredient NDA Submissiondate
TESTIM GEL;TRANSDERMAL testosterone 021454 2008-08-21

Profile for product number 001

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

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