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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Healthtrust
US Army
Johnson and Johnson
Colorcon
Express Scripts
UBS
Merck
Mallinckrodt

Generated: July 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022309

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NDA 022309 describes ANDROGEL, which is a drug marketed by Abbvie and is included in two NDAs. It is available from three suppliers. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ANDROGEL profile page.

The generic ingredient in ANDROGEL 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 022309
Tradename:ANDROGEL
Applicant:Abbvie
Ingredient:testosterone
Patents:11
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 022309
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 022309
Suppliers and Packaging for NDA: 022309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 N 0051-8462-30
ANDROGEL testosterone GEL;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 N 0051-8462-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:Apr 29, 2011TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 2, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Oct 12, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Fish and Richardson
Harvard Business School
Daiichi Sankyo
US Department of Justice
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Dow

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