Pacira BioSciences Notified of Abbreviated New Drug Application Filing from Qilu Pharmaceutical (Hainan) Co., Ltd. for EXPAREL®
PaciraPacira(US:PCRX) Globenewswire·2025-10-27 12:00

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].