On August 14, 2023, Acura Pharmaceuticals, Inc. and Zyla Life Sciences, LLC (as successor-in-interest to Egalet Corporation) agreed to terms for the termination of the Collaboration and License Agreement between Acura Pharmaceuticals, Inc. and Zyla dated January 7, 2015 for OXAYDO (oxycodone HCI tablets) in 5mg and 7.5mg strengths ("Product"). Zyla previously provided a Notice of Termination requesting a termination effective date of September 28, 2023 (?Effective Date?) to which Acura has agreed. At the Effective Date, Zyla?s licenses to Acura?s AVERSION patents and the trademarks AVERSION and OXAYDO will terminate and Zyla shall have no residual rights to manufacture, market, sell, have sold, distribute and otherwise exploit the Product.

Acura does not intend to continue marketing the Product or to actively seek a new marketing partner and has waived its right to transition of the marketing back to Acura. Zyla will retain ownership of the OXAYDO New Drug Application (?NDA?), which it intends to discontinue at the Effective Date, while Acura retains the right to transfer ownership of the NDA back to Acura up until March 16, 2025. Net sales of OXAYDO are approximately $3 million annually and Acura will continue to receive a royalty on net sales through the Effective Date.

OXAYDO (previously known as OXECTA and ACUROX) was initially licensed in 2007 to King Pharmaceuticals Research and Development, Inc. which was subsequently acquired by Pfizer, Inc. in 2011. The NDA for OXAYDO was approved by the US Food and Drug Administration in June 2011 as an early example of an opioid with abuse deterrent features with such features being highlighted in the Product?s labeling. Pfizer commenced commercialization of OXAYDO in early 2012 and terminated its license in 2014 and the Product reverted back to Acura.

OXAYDO was subsequently licensed to Zyla in early 2015 with a re-launch later that year. The majority of Acura?s U.S. patents covering OXAYDO begin expiring in November 2023 with the last patent expiring March 16, 2025. In 2013, Acura entered into settlement agreements with multiple generic manufacturers following patent infringement suits initiated by Acura against the generic companies, with Par Pharmaceuticals, Inc. being granted a royalty bearing license to Acura?s patent to begin marketing a generic after January 1, 2022.

To date, Par has not gained approval for a generic to OXAYDO.