.

Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo
Baxter
Healthtrust
Chinese Patent Office
Accenture
Johnson and Johnson
Colorcon
Cantor Fitzgerald
US Department of Justice

Generated: November 23, 2017

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-two 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:
1
Applicant:
1
Ingredient:
1
Patents:2
Formulation / Manufacturing:see details

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength750MG/3ML (250MG/ML)
Approval Date:Mar 5, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 5, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:► SubscribePatent Expiration:Mar 14, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent 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
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Cipla
Healthtrust
US Department of Justice
Medtronic
Covington
Federal Trade Commission
Cantor Fitzgerald
Boehringer Ingelheim
Moodys
AstraZeneca

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot