Pacira BioSciences received a Paragraph IV certification notice from Qilu Pharmaceutical (Hainan) Co., Ltd. regarding a generic abbreviated new drug application for its long‑acting local anesthetic EXPAREL.
The notice lists 18 patents from two families, including U.S. Patents 11,033,495; 11,179,336; 11,278,494; 11,304,904; 11,311,486; 11,357,727; 11,426,348; 11,452,691; 11,819,574; 11,819,575; 11,925,706; 12,144,890; 12,151,024; 12,156,940; 12,251,468; 12,296,047; 12,318,483; and 12,370,142. The first family expires on January 22, 2041, and the second on July 2, 2044.
Pacira has 45 days to file a lawsuit under the Hatch‑Waxman Act, which would trigger a 30‑month stay of FDA approval for the generic product. The notice alleges the patents are invalid, unenforceable, or not infringed by Qilu’s product.
EXPAREL generated $549.0 million in net product sales in 2024, representing a substantial portion of Pacira’s $701.0 million total revenue. The company’s strategy to defend its patents is critical to maintaining its market position.
This is not the first Paragraph IV challenge for EXPAREL. Pacira previously settled with Fresenius Kabi USA, Jiangsu Hengrui Pharmaceuticals, and eVenus Laboratories in April 2025, and received a notice from The WhiteOak Group on October 21, 2025. The ongoing litigation underscores the competitive pressure on Pacira’s flagship product.
Pacira’s response will determine whether it can preserve its long‑acting local anesthetic franchise and protect its revenue stream in the face of new generic entrants.
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