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Pacira BioSciences Notified of Abbreviated New Drug Application Filing from Qilu Pharmaceutical (Hainan) Co., Ltd. for EXPAREL®
BRISBANE, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative,
About this update from Pacira Biosciences, Inc.
[{"type":"text","content":"BRISBANE, Calif., Oct. 27, 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 reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from Qilu Pharmaceutical (Hainan) Co., Ltd., a private Chinese company. Qilu has filed an Abbreviated New Drug Application, or ANDA, with the FDA for a product claiming to be a generic equivalent of EXPAREL. In the PIV Notice, Qilu alleges that the claims of 18 EXPAREL patents listed in the FDA’s Orange Book (U.S. Patent Nos.11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, 12,151,024, 12,156,940, 12,251,468, 12,296,047, 12,318,483, 12,370,142) are invalid, unenforceable and/or will not be infringed by Qilu’s manufacture, use or sale of the product described in its ANDA submission. The company’s contested Orange Book listed patents are from two distinct patent families with the first family expiring on January 22, 2041, and the second family expiring on July 2, 2044. Pacira intends to vigorously assert and enforce its intellectual property rights and has 45 days from receipt of the PIV Notice to file a lawsuit if it deems the ANDA filer is infringing its intellectual property. The lawsuit will trigger an automatic 30-month stay of FDA approval of Qilu’s ANDA submission pursuant to the Hatch Waxman statute. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advanc...