Pacira Settles Patent Litigation Over EXPAREL With Fresenius Kabi, Jiangsu Hengrui, And EVenus

(RTTNews) - Pacira BioSciences Inc. (PCRX) announced that it has settled 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, the companies will file Consent Judgments with the United States Court of Appeals for the Federal Circuit and the United States District Courts for the District of New Jersey and the Northern District of Illinois that enjoin Fresenius from marketing generic bupivacaine liposome injectable suspension before the expiration of the patents-in-suit, except as provided for in the settlement.

Pacira has agreed to provide Fresenius with a license to Pacira's patents required to manufacture and sell certain volume-limited amounts of generic bupivacaine liposome injectable suspension in the United States beginning on a confidential date that is sometime in early 2030. The license will permit entry of generic bupivacaine liposome injectable suspension before the July 2, 2044 expiration date of the last-to-expire of Pacira's Orange Book-listed patents for EXPAREL.

The company noted that the agreed-upon volume-limited percentages are confidential, But the companies begin at a high-single-digit percentage of the total volumes distributed in the U.S. market and increase gradually in each 12-month period following the volume-limited entry date until reaching a percentage in the low thirties in 2033 and increasing modestly in each of the next two 12-month periods before reaching a maximum percentage in the high thirties of the total volumes distributed in the U.S. for the final three years of the agreement.

In addition, Pacira has agreed to provide Fresenius with a license to Pacira's patents required to manufacture and sell an unlimited quantity of generic bupivacaine liposome injectable suspension in the U.S. beginning no earlier than 2039.