Orexigen, Takeda File Infringement Lawsuit Against Actavis

(RTTNews) - Orexigen Therapeutics Inc (OREX) on Friday said the company and its North American partner, Takeda Pharmaceuticals, have filed a lawsuit against Actavis (ACT) in the U.S. District Court for the District of Delaware.

The suit was filed against Actavis Laboratories FL Inc, Andrx Corp, Actavis Pharma Inc, and Actavis Inc.

The lawsuit was filed in response to an Abbreviated New Drug Application filed by Actavis. In its application, Actavis seeks to market generic versions of currently approved doses of Contrave (naltrexone HCl / bupropion HCl extended release) tablets prior to the expiration of U.S. Patents listed in the FDA's Approved Drug Products. Takeda and Orexigen filed the lawsuit on the basis that Actavis' proposed generic products infringe each of these patents.

In accordance with the Hatch-Waxman Act, as a result of having filed a lawsuit within 45 days of the Paragraph IV certification notice, FDA approval of the ANDA will be stayed 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.

Orexigen and Takeda said they plan to vigorously enforce Contrave intellectual property rights.