Orexigen Therapeutics, Inc., a biopharmaceutical company, and its North American partner, Takeda Pharmaceuticals, have filed a lawsuit in the US District Court for the District of Delaware against Actavis Laboratories FL, Inc., Andrx Corporation, Actavis Pharma, Inc., and Actavis Inc., collectively referred to as Actavis. The lawsuit was filed in response to an abbreviated new drug application (ANDA) filed by Actavis. In its application, Actavis seeks to market and sell generic versions of the currently approved doses of Contrave (naltrexone HCl/bupropion HCl extended release) tablets prior to the expiration of US patents listed in the US Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. 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.

Contrave, approved by the US FDA in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/square meters or greater (obese), or 27 kg/square meters or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, Type 2 diabetes mellitus or dyslipidemia). Takeda Pharmaceuticals holds North American rights to Contrave and commercializes the medicine in the United States. In Europe, the medicine was approved in March 2015 with the brand name Mysimba.

Source: Orexigen Therapeutics