Pacira BioSciences, Inc. (Nasdaq: PCRX), a leader in non-opioid pain therapies, reported receiving a Paragraph IV Certification Notice Letter from Qilu Pharmaceutical (Hainan) Co., Ltd.
Qilu has filed an Abbreviated New Drug Application with the FDA for a product claiming to be a generic equivalent of EXPAREL, alleging that 18 EXPAREL patents are invalid.
Qilu alleges that the claims of 18 EXPAREL patents listed in the FDA's Orange Book are invalid.
Author summary: Pacira BioSciences notified of generic EXPAREL application filing.