Pacira BioSciences, Inc. (NASDAQ: PCRX) announced on October 23, 2025 that it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of Zhejiang Haichang Biotechnology Co. Ltd., regarding a pending Abbreviated New Drug Application (ANDA) for a generic version of its flagship product EXPAREL.
The notice lists 19 patents from two families— the first family expiring January 22, 2041 and the second family July 2, 2044— and requires Pacira to file a lawsuit within 45 days if it believes the ANDA infringes its intellectual property. A lawsuit would trigger a 30‑month stay of FDA approval under the Hatch‑Waxman statute, effectively delaying generic entry and preserving Pacira’s exclusivity and revenue stream from EXPAREL.
Pacira’s response underscores the importance of its patent portfolio in protecting the company’s primary cash‑flow generator. By asserting its rights, Pacira aims to maintain market dominance for EXPAREL and safeguard the company’s long‑term financial performance in the highly competitive non‑opioid pain management space.
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