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Pacira BioSciences, Inc, the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, announced that it has settled its litigations with Fresenius Kabi USA, LLC (Fresenius), Jiangsu Hengrui Pharmaceuticals Co and eVenus Pharmaceuticals Laboratories, related to patents for Exparel (bupivacaine liposome injectable suspension).
As part of the settlement, the parties will file consent judgments with the US 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 described below.
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 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.
While the agreed-upon volume-limited percentages are confidential, they begin at a high-single-digit percentage of the total volumes distributed in the US 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 months periods before reaching a maximum percentage in the high thirties of the total volumes distributed in the US 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 US beginning no earlier than 2039.
“We remain confident in our Exparel intellectual property portfolio and believe this settlement agreement appropriately recognizes the strength of our patents and provides clarity around Exparel exclusivity,” said Frank D. Lee, CEO of Pacira. “With the litigation resolved, we look forward to focusing on advancing our 5x30 strategy and building upon our 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 delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: Exparel (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis.
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