See the DrugPatentWatch profile for Exparel
Exparel, an injectable liquid intended for the treatment of pain, received FDA approval in 2021 for a new indication [1]. This approval expanded its use to include postoperative pain management in pediatric patients aged 6 to 11 years undergoing open-label hernia repair [2].
When Did Exparel Get Initial FDA Approval?
Exparel was initially approved by the FDA in October 2011 for postsurgical pain management in adults [3].
What Kind of Drug Is Exparel?
Exparel is a local anesthetic that utilizes DepoFoam technology to provide extended release of bupivacaine hydrochloride. This formulation allows for a single administration to control pain for a significant period following a surgical procedure [4].
What Are the Approved Uses for Exparel?
Since its initial approval, Exparel's indications have expanded. It is approved for controlling postoperative pain in adults following various surgical procedures, including orthopedic surgery, hemorrhoidectomy, and others [4]. The 2021 approval specifically added its use for postoperative pain in pediatric patients undergoing open-label hernia repair [2].
Are There Any Safety Concerns with Exparel?
As with any medication, Exparel has potential side effects. Common side effects reported in clinical trials include constipation, nausea, vomiting, and headache [4]. The FDA mandates post-marketing surveillance to monitor for any emerging safety issues.
How Does Exparel Work?
Exparel works by delivering bupivacaine directly to the site of incision or surgical trauma. The DepoFoam vehicle encapsulates the bupivacaine, which is then released slowly over time. This sustained release mechanism provides prolonged pain relief, reducing the need for opioid analgesics [4].
What Is the Patent Status of Exparel?
Drug patents provide market exclusivity. Information regarding the specific patents covering Exparel and their expiration dates can be found through resources like DrugPatentWatch.com [5]. Patent expiration is crucial for understanding when generic or biosimilar competition might emerge.