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Pacira BioSciences Notified of Abbreviated New Drug Application Filing for EXPAREL®
TAMPA, Fla., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"TAMPA, Fla., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, has received a Paragraph IV Certification Notice Letter advising that eVenus Pharmaceutical Laboratories, Inc. of Princeton, New Jersey, submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization for the manufacturing and marketing of a generic version of EXPAREL® (bupivacaine liposome injectable suspension) in the United States. In the Notice Letter, eVenus alleges that the claims of an FDA Orange Book-listed patent (U.S. Patent No. 11,033,495) are invalid, unenforceable and/or will not be infringed by eVenus’s manufacture, use, or sale of the product described in eVenus’s ANDA submission. The ‘495 patent marks the first deliverable from the company’s comprehensive patent strategy. This Paragraph IV challenge does not account for several additional patents that are forthcoming that include three allowed patents, two of which Pacira will file for Orange Book listing, and additional patents pending. These new patents will establish multiple layers of patent protection and extend the company’s proprietary position for EXPAREL into the 2040s. In February 2018, the FDA published rigorous criteria for proving bioequivalence to multivesicular liposomal bupivacaine. Matching comparative characteristics must be conducted on at least three batches of an ANDA product with at least one batch manufactured at commercial scale and include liposome composition, internal aqueous environment of the liposome, and in vitro drug release rates. Pacira is currently assessing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against eVenus. Pacira intends to vigorously defend its intellectual property rights relating to EXPAREL®. About Pacira BioSciences Pacira BioSciences, Inc. (Nasdaq: PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients’ journeys along the neural pain pathway. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and...