Pacira Settles Patent Dispute Over Exparel With Fresenius, Delays Pain Med' Generics Entry Until 2030, Stock Jumps

Pacira BioSciences, Inc. PCRX on Monday settled its litigations with Fresenius Kabi USA, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. related to patents for Exparel (bupivacaine liposome injectable suspension).

Exparel is Pacira BioSciences' non-opioid analgesic pain management and is indicated for postsurgical analgesia.

As part of the settlement, the parties 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.

In settlement of all outstanding claims in the litigations, 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 U.S. beginning on a confidential date that is sometime in early 2030.

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The license will permit generic bupivacaine liposome injectable suspension entry before the July 2, 2044, expiration date of the last-to-expire of Pacira’s Orange Book-listed patents for Exparel.

While the agreed-upon volume-limited percentages are confidential, they 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.

In an SEC filing, the company’s expected savings concerning, among other things, the avoidance of the fees, costs, time and resources associated with continuing the Litigations, the company will pay the Fresenius Parties $7.0 million.

Exparel net product sales were $147.7 million in the fourth quarter of 2024, a 3% year over year increase.

In August 2024, Pacira BioSciences announced that the U.S. District Court for the District of New Jersey found that the company's U.S. Patent No. 11,033,495 (the ‘495 patent) is not valid.

In November 2021, Pacira BioSciences filed a lawsuit in the United States District Court for the District of New Jersey against eVenus Pharmaceutical Laboratories for patent infringement of U.S. Patent Number 11,033,495.

Analyst Reaction:

• HC Wainwright maintains Pacira BioSciences with a Buy, raising the price target from $48 to $65.
• Needham reiterates Pacira BioSciences with a Buy and maintains a price target of $32.

Price Action: PCRX stock is up 16.8% at $26.77 at the last check on Tuesday.

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