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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022219

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NDA 022219 describes AVEED, which is a drug marketed by Endo Pharms Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AVEED profile page.

The generic ingredient in AVEED is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
Summary for 022219
Tradename:AVEED
Applicant:Endo Pharms Inc
Ingredient:testosterone undecanoate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022219
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 022219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVEED testosterone undecanoate INJECTABLE;INTRAMUSCULAR 022219 NDA Endo Pharmaceuticals Inc. 67979-511 67979-511-43 1 VIAL, SINGLE-USE in 1 CARTON (67979-511-43) > 3 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 022219
Tradename Dosage Ingredient NDA Submissiondate
AVEED INJECTABLE;INTRAMUSCULAR testosterone undecanoate 022219 2014-06-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength750MG/3ML (250MG/ML)
Approval Date:Mar 5, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 14, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 27, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

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