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. Four 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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 022219

Generic Entry Date for 022219^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing Dosage: INJECTABLE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022219

Mechanism of Action	Androgen 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	750MG/3ML (250MG/ML)
Approval Date:	Mar 5, 2014	TE:		RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	Mar 14, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	May 8, 2027	Product 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).