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 announced that it has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd. for patent infringement related to EXPAREL® (bupivacaine liposome injectable suspension).

The Pacira complaint seeks an injunction to prevent the manufacture, use, and sale of the generic products described in each company's Abbreviated New Drug Application (ANDA) filed with the U.S. Food and Drug Administration (FDA) prior to 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 currently protected by 21 patents listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). Pacira's EXPAREL patents are primarily from two distinct patent 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 successfully commercialize a generic version of EXPAREL, The WhiteOak Group and Qilu Pharmaceutical would have to effectively litigate and overcome Pacira's patents, manufacture these specific generic products on a commercial scale, establish bioequivalence, and secure approval from the FDA.

Pacira has full confidence in the strength of the EXPAREL franchise and its patent portfolio and plans to vigorously defend its intellectual property rights.