Pacira BioSciences filed a patent‑infringement lawsuit on November 26, 2025, in the U.S. District Court for the District of Delaware against The WhiteOak Group, Inc. and Qilu Pharmaceutical (Hainan) Co., Ltd. The suit seeks an injunction to halt the manufacture, use and sale of the generic products described in each company’s Abbreviated New Drug Application (ANDA) for EXPAREL, Pacira’s long‑acting local anesthetic.
The lawsuit targets the generic ANDAs for EXPAREL, a product that generated $716.8 million in revenue over the past 12 months and represents a key contributor to Pacira’s overall sales. By securing a 30‑month stay under the Hatch‑Waxman Act, Pacira delays FDA approval of the generic applications, preserving its market exclusivity while the litigation proceeds.
Pacira’s 21‑patent portfolio, including two families that expire in 2041 and 2044, underpins the company’s strategy to protect EXPAREL’s commercial life. The 30‑month stay effectively extends the period during which Pacira can maintain exclusive sales of the drug, mitigating the risk of generic competition entering the market.
The company has a history of settling similar disputes, most recently agreeing to licensing arrangements with Fresenius Kabi, Jiangsu Hengrui, and eVenus in April 2025. Those settlements allowed limited generic entry at a later date, but the current filing signals a more aggressive defense of its intellectual property and a commitment to maintaining full exclusivity for the foreseeable future.
CEO Frank D. Lee emphasized confidence in Pacira’s patent portfolio, stating the company remains committed to protecting EXPAREL’s exclusivity. The lawsuit underscores Pacira’s broader strategy to secure long‑term revenue streams from a non‑opioid pain‑management solution that reduces opioid consumption, reinforcing its value proposition in a competitive market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.