Shares of specialty pharmaceutical company Pernix Therapeutics Holdings, Inc. soared after it said it received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of pain medication Zohydro ER.
Pernix said that Judge Gregory M. Sleet of the US District Court for the District of Delaware concluded that Actavis’ proposed generic versions of Zohydro ER infringed two US patents — which expire in September 2034 and November 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,” said Pernix.
“Actavis did not assert invalidity or unenforceability of the patents at trial.”
Pernix CEO John Sedor said: “We are pleased with the court’s decision as it confirms the strength and longevity of the Zohydro ER patent portfolio.
“Zohydro ER is a core component of our product portfolio and we look forward to driving continued growth of the franchise.”
Pernix said both patents are listed in the FDA’s “Orange Book” for Zohydro ER and are licensed to Pernix by Recro Gainesville LLC.