Pernix Therapeutics Reports Issuance of New Orange Book Patent for Zohydro® ER With BeadTek™ CII

Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX) announced that the United States Patent and Trademark Office has issued U.S. Patent Number 9,265,760 (the ‘760 patent), covering important safety information related to dosing patients with Zohydro ER with BeadTek.

According to the news release:

The ‘760 patent is broadly directed to a method of dosing patients with hepatic impairment with hydrocodone where no adjustment in start dose is needed for patients with mild or moderate hepatic impairment.  

The ‘760 patent, solely owned by Pernix, will be a significant addition to the Orange Book, bringing the total of Orange Book listed patents covering Zohydro ER with BeadTek to four. The ‘760 patent will expire July 25, 2033 and will be the second patent to be listed in the last six months as covering Zohydro® ER with BeadTek in the United States Food and Drug Administration’s (FDA) Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

Doug Drysdale, Chairman and CEO of Pernix Therapeutics commented:

The critically important safety information protected by the ‘760 patent can be found in the Zohydro ER label, and this patent is expected to provide a significant barrier for generic entry. We continue to invest in the Zohydro ER franchise and currently own or license over a half dozen pending patent applications relating to Zohydro ER with BeadTek.

Click here to view the full press release.