San Diego’s Orexigen Therapeutics Inc. and its partner, Takeda Pharmaceuticals, have filed a lawsuit against Actavis Laboratories FL Inc., Andrx Corp., Actavis Pharma Inc., and Actavis Inc., collectively referred to as Actavis.
The lawsuit was filed in response to an Abbreviated New Drug Application filed by Actavis, which seeks to market and sell generic versions of the currently approved doses of Contrave tablets prior to the expiration of U.S. patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Takeda and Orexigen filed the lawsuit alledging 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 the 30 months from Takeda's receipt of the notice or a district court decision finding that the identified patents are invalid, unenforceable or not infringed.
Contrave, approved by the FDA in September 2014, is indicated for chronic weight management in obese and overweight adults.