Pernix Therapeutics Holdings Inc (NASDAQ:PTX) investors have a smile on their faces Thursday morning, after the pharmaceutical firm announced that it received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of Zohydro ER.
Pernix shares reacted to the news, jumping about 40% in early trading.
Judge Gregory M. Sleet of the United States District Court for the District of Delaware concluded that Actavis’ proposed generic versions of Zohydro ER infringe U.S. Patent Nos. 9,132,096 (which expires on September 12, 2034) and 6,902,742 (which expires on November 1, 2019) following a trial that took place in October 2016. The Judge has entered an order enjoining Actavis from engaging in the commercial manufacture, use, offer to sell, or sale in the United States, or importation into the United States of Actavis’ Abbreviated New Drug Application (ANDA) product prior to expiration of the two patents. Actavis did not assert invalidity or unenforceability of the patents at trial.
“We are pleased with the Court’s decision as it confirms the strength and longevity of the Zohydro ER patent portfolio,” said John Sedor, Chairman and CEO of Pernix. “Zohydro ER is a core component of our product portfolio and we look forward to driving continued growth of the franchise.”
Both patents are listed in the FDA’s “Orange Book” for Zohydro ER and are licensed to Pernix by Recro Gainesville LLC. Recro and another generic pharmaceutical manufacturer, Alvogen Malta Operations Ltd., filed a stipulation of dismissal last year ending a patent infringement lawsuit Recro filed against Alvogen concerning its proposed generic version of Zohydro ER.
Pernix Therapeutics Holdings, Inc. 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. The firm distributes its products under the following brands: Treximet, Silenor, Zohydro ER with BeadTek, and Khedezla.