Pacira BioSciences Shares Plummet After FDA Filing for Generic Exparel.

Pacira BioSciences' shares fell after a Chinese drugmaker filed a marketing application seeking US approval of a generic version of its non-opioid pain therapy, Exparel. The generic product could potentially erode Exparel's market share and impact Pacira's revenue.

Pacira BioSciences (NASDAQ: PCRX) saw its shares fall on Tuesday following an announcement that a subsidiary of a Chinese drugmaker has filed a marketing application seeking U.S. approval for a generic version of its non-opioid pain therapy, Exparel. The WhiteOak Group, a unit of Zhejiang Haichang Biotechnology Co. Ltd., has submitted an Abbreviated New Drug Application (ANDA) to the FDA, challenging the validity of 19 patents related to Exparel Pacira down after FDA filing for generic Exparel^[1].

The PIV Notice from WhiteOak Group claims that the patents listed in the FDA’s Orange Book are invalid, unenforceable, or will not be infringed by its generic product. Pacira has identified two patent families with expiration dates of January 22, 2041, and July 2, 2044. Pacira has 45 days from the receipt of the PIV Notice to file a lawsuit, which would trigger a 30-month stay of potential FDA approval for WhiteOak’s product Pacira BioSciences Notified of Abbreviated New Drug Application Filing from The WhiteOak Group for EXPAREL®^[2].

Exparel generated $549M in net product sales for Pacira in 2024, making up 78% of the company’s topline. The potential entry of a generic version could significantly impact Pacira's revenue and market share. Pacira intends to vigorously assert and enforce its intellectual property rights, indicating a strong stance against the generic challenge Pacira down after FDA filing for generic Exparel^[1].

Pacira BioSciences is an industry leader in delivering innovative, non-opioid pain therapies. The company has three commercial-stage treatments: Exparel, ZILRETTA, and iovera. Exparel is a long-acting local analgesic that combines bupivacaine with multivesicular liposomes to provide extended pain relief, significantly reducing opioid consumption Pacira BioSciences Notified of Abbreviated New Drug Application Filing from The WhiteOak Group for EXPAREL®^[2].

The filing of the generic product by WhiteOak Group underscores the competitive landscape in the non-opioid pain therapy market. As Pacira faces this challenge, investors will closely monitor the company's response and the potential outcomes of the legal proceedings.