Pacira BioSciences Notified of Abbreviated New Drug Application Filing from The WhiteOak Group for EXPAREL®

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]