Pernix Therapeutics Holdings, a specialty pharmaceutical company, said it entered into a settlement agreement with Actavis Laboratories FL resolving patent litigation related to pain medication Zohydro ER (hydrocodone bitartrate).
“The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Actavis’s submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market a generic version of Zohydro ER,” said Pernix.
Under the terms of the agreement, Pernix will grant Actavis a license to begin selling a generic version of Zohydro ER on March 1, 2029, or earlier under certain circumstances.
Other details of the settlement are confidential.
The launch of Actavis’s generic product is contingent upon Actavis receiving final approval from the FDA of its ANDA for a generic version of Zohydro ER.
“We are pleased to have settled the outstanding litigation and appeal with Actavis,” said John Sedor, Pernix CEO.
“This agreement underscores the strength of our intellectual property around Zohydro ER, and aids in reducing litigation costs.
“We will continue to defend our existing patents, and intend to further expand our intellectual property portfolio around each of our core brands, including Zohydro ER.”
The settlement agreement also resolves a pending appeal related to a patent litigation between Recro Gainesville LLC and Actavis, which also relates to Actavis’s proposed generic version of Zohydro ER.
Pernix said that as required by law, the parties will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review.
A patent litigation brought by Pernix against Alvogen Malta Operations Ltd. related to Alvogen’s proposed generic version of Zohydro ER remains pending in the US District Court for the District of Delaware.