-- Lawsuit triggers 30-month stay under the Hatch Waxman Act -- BRISBANE, Calif., Nov. 26, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd. for patent infringement rel ...

Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from Qilu Pharmaceutical, indicating Qilu's intent to file a generic version of EXPAREL, which may challenge Pacira's patent rights [1][2]. Company Overview - Pacira BioSciences is focused on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera [5]. - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, utilizing a unique multivesicular liposome technology [6]. Patent and Legal Context - Qilu Pharmaceutical claims that 18 patents related to EXPAREL are invalid or unenforceable, which could allow them to market a generic version [2]. - The contested patents belong to two families, with expiration dates in 2041 and 2044 [3]. - Pacira has 45 days to respond to the PIV Notice and may file a lawsuit to protect its intellectual property, which would trigger a 30-month stay on FDA approval for Qilu's ANDA submission [4].

Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from The WhiteOak Group, which has filed an Abbreviated New Drug Application for a generic version of EXPAREL, claiming that the patents are invalid or not infringed [1][2] Patent and Legal Context - WhiteOak alleges that 19 patents related to EXPAREL are invalid, unenforceable, or will not be infringed by their product [2] - The contested patents are from two families, with expiration dates of January 22, 2041, and July 2, 2044 [3] - Pacira has 45 days to file a lawsuit to protect its intellectual property rights, which would trigger a 30-month stay of FDA approval for WhiteOak's ANDA submission [4] Company Overview - Pacira specializes in non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, significantly reducing opioid consumption by up to 78% [6]

Core Insights - Pacira BioSciences has announced a strategic collaboration with Johnson & Johnson MedTech to enhance the market reach of ZILRETTA, an extended-release treatment for osteoarthritis knee pain, by leveraging Johnson & Johnson's specialized sales force [1][2] - The partnership aims to significantly increase ZILRETTA sales calls and expand patient access, targeting a substantial portion of the seven million intra-articular knee injections administered annually in the U.S. [1][3] Company Overview - Pacira BioSciences specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [4] - ZILRETTA is the first and only extended-release intra-articular therapy approved by the FDA for osteoarthritis-related knee pain, utilizing proprietary microsphere technology for prolonged pain relief [5] Strategic Collaboration Details - The collaboration with Johnson & Johnson MedTech will enhance promotional efforts and extend ZILRETTA's reach beyond orthopedic practices into other specialties such as sports medicine, pain management, and rheumatology [3] - This partnership is part of Pacira's "5x30 strategy," which focuses on leveraging targeted collaborations to drive growth and improve patient outcomes with non-opioid treatments [2]

Core Insights - Pacira BioSciences, Inc. is focusing on non-opioid pain therapies to improve patient outcomes and reduce opioid dependency [1][4] - The film "The Next Frontier: Mark & Leah's Story" showcases the personal journey of Mark Allen, who overcame opioid dependency through non-opioid treatments [2][3] - The opioid crisis remains a significant public health issue, with chronic pain affecting approximately 82 million Americans and costing the U.S. up to $635 billion annually [4] Company Overview - Pacira offers three commercial-stage non-opioid treatments: EXPAREL, ZILRETTA, and iovera°, aimed at managing pain without opioids [5] - EXPAREL is a long-acting local analgesic approved for various pain management applications, while ZILRETTA is for osteoarthritis knee pain, and iovera° provides drug-free pain control [5] - The company is also developing PCRX-201, a gene therapy targeting prevalent diseases like osteoarthritis [5] Industry Context - The U.S. experienced approximately 80,391 drug overdose deaths in 2024, with opioid-related deaths decreasing to 54,743, indicating a need for alternative pain management solutions [4] - Despite the decline in opioid-related deaths, the overall opioid crisis continues to have a severe impact on public health [4] - Investment in novel pain treatments has decreased, highlighting the urgent need for innovative non-opioid therapies [4]