Pernix Therapeutics Announces Ruling in Patent Litigation Concerning Zohydro ER with BeadTek

Pernix Therapeutics (NASDAQ:PTX), a specialty pharmaceutical company, announced today that in the Company’s litigation against Alvogen Malta, the United States District Court for the District of Delaware found the asserted claims of U.S. Patent Nos. 9,265,760 and 9,339,499, which relate to methods of treating patients with mild and moderate hepatic impairment with hydrocodone bitartrate, to be infringed, but invalid.

As quoted in the press release:

While Pernix is pleased that the Court confirmed that Alvogen has infringed, it is disappointed with the Court’s invalidity ruling and intends to appeal this aspect of the Court’s decision.  Absent a reversal of the Court’s decision, pursuant to a previous settlement agreement dated September 29, 2016, between Alvogen and Recro Gainsville LLC, Alvogen can launch a generic version of Zohydro® ER with BeadTek®, subject to final approval of an ANDA from the FDA, as early as October 1, 2019.  All other terms of the settlement agreement are confidential.

Further, the Court’s decision has no immediate impact on Pernix’s settlement agreement with Actavis Laboratories FL that was announced on January 29, 2018, and also relates to a proposed generic version of Zohydro® ER with BeadTek®.  Under the terms of the Actavis settlement agreement, Pernix granted Actavis a license to begin selling a generic version of Zohydro^® ER with BeadTek® on March 1, 2029.  The launch of Actavis’s generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro^® ER with BeadTek®.

Click here to read the full press release.