VIVUS, Inc. VVUS has filed a lawsuit in the U.S. District Court for the District of New Jersey against Teva Pharmaceutical Industries Ltd. TEVA in response to an Abbreviated New Drug Application (ANDA) filed by the latter for the generic version of VIVUS’ obesity product Qsymia capsules CIV.
Teva intends to market and sell generic version of Qsymia capsules CIV before the expiration of certain patents listed in the Orange Book of the FDA.
As per the Hatch-Waxman Act, as the lawsuit has been filed within 45 days of the Paragraph IV certification notice, the FDA approval of the ANDA will be stayed until the earlier of the two cases – 30 months from VIVUS’ receipt of the notice or a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.
Qsymia is the lead product at VIVUS recording sales of $45.3 million in 2014. VIVUS’ financial performance hinges on the success of the drug. Sooner-than-expected entry of Qsymia generics will be a huge loss for VIVUS.
Also we are concerned about the competitive scenario in the obesity market. The obesity market already has products like Belviq, Contrave and Saxenda. We expect investor focus to remain on Qsymia going forward.