Press Release

Pernix Therapeutics Prevails in Zohydro® ER ANDA Litigation

MORRISTOWN, N.J., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company with a focus on Pain and CNS conditions, announced today that it received a favorable opinion in its litigation with Actavis Laboratories FL, Inc. regarding a proposed generic version of Zohydro ER. 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.

About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its integrated Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.

To learn more about Pernix Therapeutics, visit www.pernixtx.com.

 

CONTACT
Investor Relations
Matthew P. Duffy, 212-915-0685
LifeSci Advisors, LLC
matthew@lifesciadvisors.com

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