VIVUS has filed a lawsuit in the U.S. District Court for the District of New Jersey against Actavis Laboratories FL, Inc., Actavis, Inc., and Actavis PLC, collectively referred to as Actavis.
The lawsuit was filed in response to an Abbreviated New Drug Application, or ANDA, filed by Actavis. In its application, Actavis seeks to market and sell generic versions of the currently approved doses of Qsymia® (phentermine and topiramate extended-release) capsules CIV prior to the expiration of U.S. Patents 7,056,890, 7,553,818, 7,659,256, 7,674,776, 8,580,298, and 8,580,299, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. VIVUS filed the lawsuit on the basis that Actavis's proposed generic products infringe each of these patents held by VIVUS.
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 VIVUS's receipt of the notice or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.