Pacira BioSciences, Inc. (NASDAQ: PCRX) witnessed a sharp surge in its stock price following the resolution of its long-standing patent disputes. In after-hours trading, shares climbed by 22.59%, reaching $28.08.
The favorable market response follows PCRX’s announcement of a comprehensive settlement involving key litigants Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. concerning patents associated with EXPAREL, its proprietary bupivacaine liposome injectable suspension.
Settlement Terms and Legal Outcomes
As stipulated in the agreement, Consent Judgments will be submitted to the U.S. Court of Appeals for the Federal Circuit and U.S. District Courts in New Jersey and Northern Illinois. These filings will legally prohibit Fresenius from marketing a generic version of the drug prior to the expiration of the patents in question—except as specifically outlined in the settlement.
Under the agreement, Pacira has granted Fresenius a license to its patents, enabling it to manufacture and distribute limited volumes of generic bupivacaine liposome injectable suspension in the United States beginning on a confidential date in early 2030. This early entry precedes the July 2, 2044 expiration of the latest listed patent for EXPAREL in the FDA’s Orange Book.
Gradual Market Entry and Volume Limits
Although specific volume figures remain confidential, the agreement outlines a phased approach. Market entry will begin at a high-single-digit percentage of U.S. distribution and gradually increase on an annual basis. By 2033, this share is expected to reach the low thirties, with incremental growth leading to a maximum market share in the high thirties during the final three years of the agreement. Additionally, Fresenius will receive the right to manufacture and sell unlimited quantities beginning no earlier than 2039.
Strategic Focus and Forward Outlook
Pacira emphasized its confidence in the strength of its intellectual property. In order to ensure product exclusivity for EXPAREL, PCRX sees this resolution as a crucial step in validating its patent portfolio. Now that the lawsuit is over, Pacira plans to put more effort into its “5×30 strategy,” which calls for growing its market share in musculoskeletal pain management and creating cutting-edge treatments to treat chronic pain in the United States.
