FDA approves Jiangsu Hengrui’s generic Exparel

The Food and Drug Administraton has approved Jiangsu Hengrui Pharma's application for bupivacaine liposome, which is a generic of Pacira BioScience's non-opioid pain drug Exparel.

Hengrui is the parent company of eVenus Pharmaceutical Laboratories, which has been involved in patent litigation with Pacira over plans to sell a generic version of Exparel, per a Market Watch report, which noted that sales of Exparel accounted for $132.4 million of Pacira's first-quarter revenue of $167.1 million.

While the report said that information on the status of the patent litigation wasn't immediately available, it noted that during Pacira's first-quarter earnings, executives said they were expecting a court ruling by the end of June. 

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

eVenus won't be able to commercially launch its generic version of Exparel until the late 2030s at a minimum, the report said.

In a research note, Truist said that even if the initial court ruling is partially in favor of eVenus, an appeal by Pacira would trigger a 30-month stay. The analysts also note that Pacira has additional patents filed that will need to be litigated by eVenus "with little success, in our view,” per the report.

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