BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Covington
Healthtrust
Harvard Business School
Moodys
Express Scripts
US Army
Novartis
Julphar
Cipla

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021454

« Back to Dashboard

NDA 021454 describes TESTIM, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from four 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-two 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
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 Stat Rx USA 16590-853 16590-853-30 30 TUBE in 1 PACKAGE (16590-853-30) > 5 g in 1 TUBE
TESTIM testosterone GEL;TRANSDERMAL 021454 NDA Physicians Total Care, Inc. 54868-4989 54868-4989-0 30 TUBE in 1 CARTON (54868-4989-0) > 5 g in 1 TUBE

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Moodys
Julphar
Fuji
Queensland Health
Boehringer Ingelheim
Citi
McKesson
Federal Trade Commission

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.

botpot