US obesity speciality Orexigen Therapeutics (Nasdaq: OREX) and partner, Japan’s Takeda Pharma (TYO: 4502) have received notification of a Paragraph IV certification for certain patents for their weight management product Contrave (naltrexone HCl and bupropion HCl extended release) which are listed in the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.
The certification resulted from the filing by Actavis (NYSE: ACT) of an Abbreviated New Drug Application (ANDA) challenging such patents for Contrave. Orexigen and Takeda plan to vigorously enforce Contrave intellectual property rights.
In accordance with the Hatch-Waxman Act, Takeda and Orexigen have 45 days after effective notice of the Paragraph IV certification to file suit against the ANDA filer in order to obtain an automatic stay of FDA approval of the ANDA until the earlier of (i) 30 months from Takeda's receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze