Pacira Biosciences' EXPAREL (bupivacaine liposome injectable suspension) is currently under patent protection, with key patents expiring in the coming years.
When Does EXPAREL's Patent Protection End?
The primary U.S. patents protecting EXPAREL are set to expire in 2028. Specifically, U.S. Patent No. 9,895,424 is listed as expiring on March 2, 2028 [1]. Other related patents also contribute to its exclusivity. DrugPatentWatch.com tracks these patent expiries and potential generic entry dates [1].
Can Generic Versions of EXPAREL Be Filed Before 2028?
While the main patent expires in 2028, the actual launch of generic versions can be influenced by patent litigation and regulatory pathways. Companies can file Abbreviated New Drug Applications (ANDAs) for generics once a generic drug manufacturer believes it can demonstrate bioequivalence and that any valid patents are expired, invalid, or will not be infringed [2].
What is the Status of EXPAREL Generic Filings?
As of now, there is no approved generic version of EXPAREL on the market. The landscape for generic drug approvals involves complex patent challenges and regulatory reviews. Information on specific generic filings often emerges as these processes advance.
How Does EXPAREL Work?
EXPAREL is a non-opioid local anesthetic that utilizes DepoFoam technology. This technology is a multivesicular liposome in which the anesthetic is encapsulated. It is designed to provide pain control for an extended period after a single administration [3]. It works by slowly releasing bupivacaine into the target area, providing localized pain relief [3].