Pacira BioSciences is not filing a generic notification for EXPAREL. Instead, the company is responding to a Paragraph IV certification notice filed by Teva Pharmaceuticals, which asserts that Teva's proposed generic version of EXPAREL does not infringe on certain Pacira patents [1].
What is EXPAREL and why is Teva challenging its patents?
EXPAREL, developed by Pacira BioSciences, is a liposomal bupivacaine product used for local anesthesia. It provides pain relief for up to 72 hours after a single administration [2]. Teva Pharmaceuticals has filed a Paragraph IV certification notice, indicating that it believes certain patents protecting EXPAREL are invalid or will not be infringed by its generic version. This is a common pathway for generic drug manufacturers to challenge existing drug patents and seek market entry for their products [3].
What does a Paragraph IV certification mean for Pacira?
A Paragraph IV certification is a notification under the Hatch-Waxman Act. When a generic company submits an Abbreviated New Drug Application (ANDA) and certifies that its product does not infringe on listed patents, or that those patents are invalid, the patent holder has a limited time to respond. Pacira, as the patent holder, has the opportunity to sue Teva for patent infringement within 45 days of receiving Teva's notice [3]. If Pacira files a lawsuit, it can trigger an automatic 30-month stay on the FDA's approval of Teva's ANDA, preventing the generic from entering the market during that period or until a court rules on the patent validity [4].
What patents are involved in the EXPAREL litigation?
Pacira has listed several patents related to EXPAREL in the FDA's Orange Book. These patents cover various aspects of the drug, including its formulation and method of use. Teva's Paragraph IV certification specifically challenges the validity or non-infringement of some of these patents [1][3]. Details about which specific patents are being challenged are typically found in legal filings and may be publicly available through patent litigation databases. DrugPatentWatch.com tracks patent information for branded drugs, including those for EXPAREL [5].
When could a generic version of EXPAREL become available?
The availability of a generic EXPAREL depends on the outcome of the patent litigation initiated by Teva's Paragraph IV certification. If Pacira sues Teva and the 30-month stay is triggered, generic entry would be delayed. If Pacira does not sue, or if the litigation concludes with a ruling favoring Teva, the FDA could approve Teva's ANDA, allowing the generic to launch sooner. Without patent litigation, generic entry could occur after the 30-month stay expires or if the FDA approves the ANDA before that period [4].