Pernix Therapeutics Holdings Inc (NASDAQ:PTX) announced that it has entered into a settlement agreement with Actavis Laboratories FL (“Actavis”) resolving patent litigation related to Zohydro® ER (hydrocodone bitartrate). The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Actavis’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic version of Zohydro® ER.
Under the terms of the agreement, Pernix will grant Actavis a license to begin selling a generic version of Zohydro® ER on March 1, 2029, or earlier under certain circumstances. Other details of the settlement are confidential. 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.
“We are pleased to have settled the outstanding litigation and appeal with Actavis,” said John Sedor, Pernix’s Chairman and Chief Executive Officer. “This agreement underscores the strength of our intellectual property around Zohydro® ER, and aids in reducing litigation costs. We will continue to defend our existing patents, and intend to further expand our intellectual property portfolio around each of our core brands, including Zohydro® ER.”
The settlement agreement also resolves a pending appeal related to a patent litigation between Recro Gainesville LLC and Actavis, which also relates to Actavis’s proposed generic version of Zohydro® ER.
As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
A patent litigation brought by Pernix against Alvogen Malta Operations Ltd. related to Alvogen’s proposed generic version of Zohydro® ER remains pending in the U.S. District Court for the District of Delaware.
Shares of Pernix are currently trading almost flat – up $0.01 or 0.41% – to trade at $2.42. PTX has a 1-year high of $7.15 and a 1-year low of $2. The stock’s 50-day moving average is $2.52 and its 200-day moving average is $2.88.
Pernix engages in the research, development, and manufacture of biopharmaceutical products. It focuses on therapeutics for diseases on central nervous system, neurology, pain, and psychiatry. Its products include treatment of migraine pain and inflammation, insomnia, and depressive disorder. It distributes products under the following brands: Treximet, Silenor, Zohydro ER with BeadTek, and Khedezla.