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Pernix Therapeutics Overcomes Challenge to Treximet® ‘183 Patent

MORRISTOWN, N.J., May 09, 2016 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (PTX), a specialty pharmaceutical company, today announced that on May 6, 2016, the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) denied a petition for inter partes review (IPR) filed by Graybar Pharmaceuticals, LLC (now Gray Square Pharmaceuticals, LLC) against Pozen, Inc. This petition, which was filed on November 12, 2015, sought review of certain claims of U.S. Patent No. 7,332,183 (’183 patent), which expires 2026. The ‘183 patent is licensed by Pernix and is one of several FDA Orange Book listed patents covering Treximet®, manufactured and sold by Pernix Therapeutics, (sumatriptan/naproxen sodium), a prescription medication for acute migraine attacks, with or without aura.

The PTAB Ruled: “After considering the Petition and Preliminary Response, we determine that Petitioner has not established a reasonable likelihood of prevailing with respect to any of the challenged claims of the ’183 patent. See 35 U.S.C. § 314(a). Accordingly, we deny the Petition, and do not institute inter partes review.”

“We are pleased with the PTAB’s decision to deny Gray Square’s petition,” said Doug Drysdale, Chairman and CEO of Pernix. “We continue to be confident in the validity of the ’183 patent and the other FDA Orange Book listed patents covering Treximet as well as all of our brands.”

The ‘183 patent has resulted in the denial of at least three generic companies gaining market entry until 2026. The validity of the ‘183 patent has been previously up-held by the Federal Circuit and now the PTAB; further strengthening this patent and reinforcing limited generic entry beyond 2018 and until the ‘183 patent expires in 2026. As a result, Pernix expects to retain a meaningful market share with its own authorized generic version of Treximet, which it intends to launch via its Macoven subsidiary, in 2018.

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