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Kabi Pens Agreement To Launch Generic Exparel In 2030 – With A Volume Limit

German Firm And Partner Jiangsu Hengrui Face Near Decade Of Cap On Volumes

 
• By Dean Rudge

With sales of $550m last year and a high barrier to entry, Exparel marks an intriguing target for abbreviated new drug application sponsors. Having shot down a US patent last year and won US FDA approval for its ANDA, Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary and partner Fresenius Kabi have just reached a settlement agreement.

Target_2030
• Source: Shutterstock

Fresenius Kabi is set to enjoy a 14-year jump on the US patents shielding Pacira BioSciences’ Exparel (bupivacaine) liposomal injectable, albeit with a volume limit that will last for nearly a decade, under the terms of a patent-litigation settlement agreement that resolves all outstanding legal proceedings. Exparel brought in sales of $550m last year.

The settlement provides Kabi with a license to Pacira’s patents required to manufacture and sell certain “volume-limited amounts” of generic bupivacaine liposome injectable suspension in the US beginning on a

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