Pacira Stock Slides 6.7% On ANDA Filing Threat To Flagship Drug

(RTTNews) - Pacira BioSciences, Inc. (PCRX) dropped 6.69% to $21.48, down $1.54, after receiving a Paragraph IV certification notice from The WhiteOak Group, which filed an Abbreviated New Drug Application - ANDA challenging the patents covering Pacira's lead product EXPAREL.

WhiteOak alleges that 19 patents listed in the FDA's Orange Book are invalid or non-infringed, threatening Pacira's market exclusivity. Pacira has 45 days to file suit, which, if done, would trigger a 30-month stay of FDA approval for the generic.

The challenge raises strategic risk for Pacira's non-opioid pain platform and could affect revenue forecasts and valuation if litigation or generic competition emerges.