FDA Approves Pacira Bioscience's EXPAREL Manufacturing Process

FDA approves Pacira’s Exparel manufacturing process to meet its growing demand for pain management.

FREMONT, CA: Pacira BioSciences announces that FDA has approved its enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension), which is housed at a custom facility in Swindon, England, under a partnership with Thermo Fisher Scientific Pharma Services. The company is expected to start selling commercial products manufactured in this 200-liter suite by the end of 2021.

“This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL,” said Dave Stack, chairman, and chief executive officer of Pacira BioSciences. “Launching this new manufacturing site marks an important milestone for Pacira that will allow us to double our capacity to meet the growing demand for EXPAREL, while simultaneously improving our gross margins and extending our market exclusivity into 2041.”

In June 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,033,495 related to EXPAREL. 

The patent, Manufacturing of Bupivacaine Multi vesicular Liposomes, claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA's Approved “Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) in July 2021.

Pacira BioSciences is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patient’s journey along the neural pain pathway.

EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients six years of age and above for single-dose infiltration to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. A single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption.