Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
Express Scripts
McKesson
Boehringer Ingelheim
Fish and Richardson
Argus Health
McKinsey
Cipla

Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022219

« Back to Dashboard

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-seven drug master file entries for this compound. One supplier is 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
Generic Entry Opportunity 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
Ingredient-typeAndrostanes
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 Solutions 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:RXDosage:INJECTABLE;INTRAMUSCULARStrength750MG/3ML (250MG/ML)
Approval Date:Mar 5, 2014TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 14, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent 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).

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
Healthtrust
Express Scripts
Farmers Insurance
McKesson
Baxter
Fuji
Harvard Business School

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.