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Press Release

Pernix Therapeutics Announces the Issuance of Two New Orange Book Listed Patents for Zohydro® ER with BeadTek™

Posted on: 14 Sep 16

MORRISTOWN, N.J., Sept. 14, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company, today announced that the United States Patent and Trademark Office has issued U.S. Patent Numbers 9,421,200 (‘200 patent) and 9,433,619 (‘619 patent), covering important safety information related to dosing patients with Zohydro® ER with BeadTek™. These patents, in addition to recently issued U.S. Patent Numbers 9,265,760 (‘760 patent), 9,326,982 (‘982 patent), 9,333,201 (‘201 patent) and 9,339,499 (‘499 patent), are broadly directed to methods of dosing patients with mild or moderate hepatic impairment with hydrocodone.  The ‘760, ‘982, ‘201, ‘499, ‘200, and ‘619 patents expire on July 25, 2033.

“The ‘200 and ‘619 patents, solely owned by Pernix, further strengthen our intellectual property portfolio covering Zohydro ER with BeadTek,” said John Sedor, Chairman and CEO of Pernix Therapeutics.  “With the addition of these patents, Zohydro ER with BeadTek currently has nine patents listed in the FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. In addition, several other patent applications related to this product are pending.”

About Zohydro ER with BeadTek
Zohydro ER with BeadTek is an extended-release form of hydrocodone indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER with BeadTek does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. The active ingredient, hydrocodone, is the most commonly prescribed opioid in the U.S., with over 90 million prescriptions in 2015. Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents.  As covered by the ‘760, ‘982, ‘201, ‘499, ‘200 and ‘619 patents, no adjustment in starting dose for Zohydro ER is required for patients with mild or moderate hepatic impairment.  Zohydro ER with BeadTek is available in strengths 10mg, 15 mg, 20mg, 30 mg, 40mg, and 50mg.

For more information on Zohydro ER with BeadTek including important safety information and the full prescribing information, visit

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 two Pernix sales forces and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.

To learn more about Pernix Therapeutics, visit

Zohydro® ER is a registered trademark of Pernix Therapeutics Holdings, Inc.  BeadTek™ is a trademark used by Pernix under license.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements.  These statements reflect the Company’s current views, expectations and beliefs concerning future events.  These forward-looking statements include statements regarding:  planned development activities relating to a next-generation version of Zohydro ER, estimated annualized cost savings and potential for future revenue growth and profitability resulting from the restructuring of our salesforce and the recent management changes, increased usage of our three core products, Treximet, Silenor and Zohydro ER, increased usage of our prescription fulfillment program, Pernix Prescriptions Direct, and improved financial flexibility through a possible restructuring of our debt and other potential alternatives. The inclusion of forward-looking statements should not be regarded as a representation by Pernix that any of its plans will be achieved.  Investors should note that many factors, including the risks and uncertainties inherent in Pernix’s business, as more fully described in Pernix’s filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015 and subsequent filings with the SEC, could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in this press release.  The forward-looking statements in this press release are qualified by these risk factors.  These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


Last updated on: 15/09/2016

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