Pacira BioSciences, Inc. (Nasdaq: PCRX) announced today that it has reached a settlement agreement with Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. regarding patent litigation for its flagship product EXPAREL® (bupivacaine liposome injectable suspension).
The settlement resolves all outstanding claims in the litigation and establishes a clear timeline for generic entry into the market. Under the terms of the agreement, Fresenius Kabi will be licensed to sell volume-limited amounts of generic bupivacaine liposome injectable suspension in the United States beginning on a confidential date in early 2030, well before the July 2, 2044 expiration date of Pacira's last Orange Book-listed patent for EXPAREL.
Settlement Terms and Market Impact
The agreement includes specific volume limitations that begin at a high-single-digit percentage of the total U.S. market distribution and increase gradually over time. According to the settlement, these percentages will rise to the low thirties by 2033 and reach a maximum in the high thirties during the final three years of the agreement.
Additionally, Pacira has granted Fresenius Kabi a license to manufacture and sell unlimited quantities of generic bupivacaine liposome injectable suspension in the U.S. 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, chief executive officer 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."
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. These judgments will prohibit Fresenius from marketing generic versions of the drug before the expiration of the patents-in-suit, except as specifically permitted by the settlement agreement.
EXPAREL's Market Position and Clinical Applications
EXPAREL is a long-acting local analgesic that represents a cornerstone of Pacira's non-opioid pain management portfolio. The drug is currently approved for multiple applications, including infiltration, fascial plane block, interscalene brachial plexus nerve block, adductor canal nerve block, and sciatic nerve block in the popliteal fossa for postsurgical pain management.
The settlement provides Pacira with a predictable timeline regarding market exclusivity for EXPAREL, allowing the company to continue its focus on expanding applications for the drug while developing its broader non-opioid pain management portfolio.
Pacira's Non-Opioid Pain Management Portfolio
Beyond EXPAREL, Pacira has established itself as a leader in non-opioid pain therapies with two other commercial products: ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release intra-articular injection for osteoarthritis knee pain, and iovera°, a novel handheld device that delivers immediate, long-acting, drug-free pain control using controlled cold temperature to target specific nerves.
The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with potential applications for treating prevalent conditions like osteoarthritis.
Strategic Implications
The resolution of this patent litigation represents a significant strategic win for Pacira, providing clarity on the timeline for generic competition while affirming the strength of the company's intellectual property. By securing market exclusivity for EXPAREL until at least 2030, with volume limitations extending well beyond that date, Pacira has protected a critical revenue stream that supports its ongoing research and development efforts.
The settlement allows Pacira to focus on its "5x30" strategy, though specific details of this initiative were not elaborated in the announcement. Industry analysts will likely view this development positively, as it removes a significant uncertainty regarding the company's future revenue projections and market position in the non-opioid pain management space.
Market Context and Unmet Needs
The settlement comes at a time when non-opioid pain management solutions continue to gain importance in addressing the ongoing opioid crisis. EXPAREL and Pacira's other products represent important alternatives for clinicians seeking to reduce opioid prescriptions while effectively managing acute and chronic pain.
With this litigation resolved, Pacira appears well-positioned to continue its leadership in developing innovative approaches to pain management that address significant unmet medical needs while reducing reliance on opioid medications.
