BRISBANE, Calif. — November 26, 2025 — Leads & Copy — Pacira BioSciences, Inc. (Nasdaq: PCRX) has filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd.
The lawsuit concerns patent infringement related to EXPAREL® (bupivacaine liposome injectable suspension). Pacira is seeking an injunction to prevent the manufacture, use, and sale of generic products described in each company’s Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) before the expiration of Pacira’s EXPAREL patents.
The lawsuits triggered a 30-month stay of final FDA approval of the ANDAs under the Hatch Waxman Act.
EXPAREL is protected by 21 patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). These patents are from two distinct families and were granted after review by multiple examiners at the U.S. Patent and Trademark Office. The first family has an expiration date of January 22, 2041, and the second has an expiration date of July 2, 2044.
To commercialize a generic version of EXPAREL, The WhiteOak Group and Qilu Pharmaceutical would need to litigate and overcome Pacira’s patents, manufacture the products on a commercial scale, establish bioequivalence, and secure FDA approval.
Pacira said it has confidence in the strength of the EXPAREL franchise and its patent portfolio and plans to defend its intellectual property rights.
Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension); ZILRETTA® (triamcinolone acetonide extended-release injectable suspension); and iovera°º, a handheld device for delivering drug-free pain control.
The company is also developing PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy for treating diseases like osteoarthritis.
EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks.
The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. A single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated.
EXPAREL should not be used in obstetrical paracervical block anesthesia. Common side effects include nausea, constipation, and vomiting. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement, potentially lasting up to 5 days. It is not recommended for patients younger than 6 years old for injection into a wound, or younger than 18 years old for injection near a nerve, or in pregnant women. Patients with liver disease should consult their healthcare provider.
Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com
Media Contact: Kim Hamilton, (973) 254-4644 kim.hamilton@pacira.com
Source: Pacira BioSciences, Inc.
