Acura Pharmaceuticals, Inc. entered into a settlement agreement with Impax Laboratories, Inc. and Par Pharmaceutical Companies, Inc. to resolve their patent litigation regarding Oxecta. Par was acquired by TPG Capital in 2012.
Oxecta is approved to manage the acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
With the litigation being settled, Par can now sell its generic version of Oxecta in the U.S. on Jan 1, 2022 or before under certain circumstances. Par’s launch of generic Oxecta depends on Acura’s grant of a non-exclusive, royalty-bearing license to Par. Par being the first Abbreviated New Drug Application filer for generic Oxecta is entitled to a 180-day exclusivity. Acura is entitled to get royalties of 10%–15% of Par's net profits from generic Oxecta sales.
As per the agreement, Impax can sell its generic version of Oxecta in the U.S. through the grant of a non-exclusive, royalty-free license from Acura. This will be effective 180 days after the first sale of a generic Oxecta in the U.S. or before under certain circumstances.
Meanwhile, other generic companies including Ranbaxy and Actavis Inc. (ACT - Free Report) are also seeking approval from the FDA to sell their generic version of Oxecta. Patent litigation against them is pending in the U.S. District Court. Acura has challenged the applications from these companies alleging infringement of U.S. patent no. 7,510,726, expiring in Nov 2023.
Acura currently carries a Zacks Rank #4 (Sell). Other companies that look well-positioned include Impax and Actelion Ltd. . While Actelion carries a Zacks Rank #1 (Strong Buy), Impax carries a Zacks Rank #2 (Buy).