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Shares of Pacira BioSciences PCRX are rising today after the company announced that it has entered into a settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals and eVenus Pharmaceuticals Laboratories, related to patents for Exparel (bupivacaine liposome injectable suspension).
Following the settlement, which resolves the patent litigation brought by Pacira BioSciences against the companies, Consent Judgments will be filed in multiple courts, preventing Fresenius, like the others, from marketing generic bupivacaine liposome injectable suspension before the relevant patents expire, except as outlined in the agreement.
Exparel is PCRX’s flagship pain-management product, which was initially launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.
Year to date, shares of Pacira BioSciences have gained 21.6% against the industry’s 8.9% decline.
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PCRX’s Litigation Settlement Terms With Fresenius in Detail
As part of the settlement, Pacira BioSciences granted Fresenius a license to its patents, allowing limited-volume sales of generic bupivacaine liposome injectable suspension in the United States starting in early 2030. This license permits market entry of generic versions before the final patent for Exparel expires on July 2, 2044.
The exact volume limits have not been disclosed by PCRX. However, Fresenius will initially distribute a high-single-digit percentage of the total U.S. market supply and gradually increase each year, reaching the low thirties by 2033. It will continue to rise modestly over the following two years before peaking in the high thirties during the agreement’s final three years. Additionally, Pacira has granted Fresenius a license to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the United States, beginning no earlier than 2039.
This is a huge win for Pacira BioSciences. It protects the company’s Exparel sales from generic erosion in the U.S. market for pain management while enabling it to focus on other strategic priorities. The drug is the primary top-line driver for PCRX. In 2024, the drug generated sales worth $549 million, which indicates a rise of 2% year over year in the United States. Exparel sales accounted for 79% of the company’s net product revenues recognized during the same period.