Acura Pharma settles with Par and Impax over Oxecta

US specialty pharma firm Acura Pharmaceuticals (Nasdaq: ACUR) saw its shares leap as much as 28% after it said that it has entered into distinct settlement agreements with each of Par Pharmaceutical (NYSE: PRX) and Impax Laboratories (Nasdaq: IPXL), to settle Acura's patent infringement action pending against them in the US District Court for the District of Delaware.

In the suit, Acura alleges that a generic Oxecta (oxycodone), a Pfizer drug for which Par and Impax are separately seeking approval to market in the USA under an Abbreviated New Drug Application filing with the US Food and Drug Administration, infringes a US patent owned by Acura. Par is the first filer of an ANDA for a copy of Oxecta and is entitled to the 180-day first filer exclusivity under applicable law and FDA regulations. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Under the terms of the accord with Par, the latter may launch its generic Oxecta in the USA, through the grant of a non-exclusive, royalty-bearing license from Acura to Par that would trigger on January 1, 2022. Acura currently has Orange Book patents that are due to expire between November 2023 and March 2025.