Details for New Drug Application (NDA): 022219
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NDA 022219 describes AVEED, which is a drug marketed by Endo Operations 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. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
The generic ingredient in AVEED is testosterone undecanoate. There are sixty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the testosterone undecanoate profile page.
Summary for 022219
| Tradename: | AVEED |
| Applicant: | Endo Operations |
| Ingredient: | testosterone undecanoate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022219
Generic Entry Date for 022219*:
Constraining patent/regulatory exclusivity:
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 USA, 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: | 7,718,640 | Patent Expiration: | Mar 14, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,338,395 | 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). | ||||||||
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