Pacira Biosciences, Inc. (NASDAQ: PCRX) has announced a settlement in its litigations with Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and Evenus Pharmaceuticals Laboratories, Inc. related to patents for Exparel® (bupivacaine liposome injectable suspension). As part of the settlement, Pacira will provide Fresenius with a license to its patents required to manufacture and sell certain volume-limited amounts of generic bupivacaine liposome injectable suspension in the United States beginning in early 2030. The agreed-upon volume-limited percentages are confidential, but they start at a high-single-digit percentage and gradually increase in each 12-month period, reaching a percentage in the low thirties in 2033 and increasing modestly in the following years until reaching a maximum percentage in the high thirties for the final three years of the agreement.
Additionally, Pacira has agreed to provide Fresenius with a license to its patents required to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the U.S. beginning no earlier than 2039.
Frank D. Lee, Chief Executive Officer of Pacira, expressed confidence in the Exparel intellectual property portfolio and stated that the settlement agreement appropriately recognizes the strength of their patents and provides clarity around Exparel exclusivity. With the litigation resolved, the company looks forward to focusing on advancing its 5x30 strategy and building upon its leadership position in musculoskeletal pain and adjacencies by developing new treatments that address the significant unmet needs of millions of Americans living with chronic pain.
Pacira Biosciences prides itself on delivering innovative, non-opioid pain therapies to transform the lives of patients. The company's three commercial-stage non-opioid treatments are Exparel® (bupivacaine liposome injectable suspension), Zilretta® (triamcinolone acetonide extended-release injectable suspension), and Iovera®º. Pacira is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. Today the company's shares have moved 13.4% to a price of $25.98. For more information, read the company's full 8-K submission here.