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FDA Approves First Generic Exparel – But What Will The Courts Say?

ANDA Holder eVenus Predicted To Settle; Potential For 2041 US Launch Or Later

 
• By Dean Rudge

Despite the first and only US FDA approval, Jiangsu Hengrui’s US eVenus has been tipped to stay out of the generic Exparel market until at least the end of the 2030s. Generics Bulletin investigates.

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• Source: Shutterstock

Jiangsu Hengrui’s US eVenus Pharmaceutical Laboratories subsidiary has won US Food and Drug Administration approval for the first generic version of Pacira BioSciences’ Exparel (bupivacaine) liposomal injectable, the long-acting local analgesic for post-surgical pain which brought in sales of nearly $550m last year.

Guarded strongly by demanding bioequivalence guidance and a litany of patents, Exparel has faced almost no threat from generic competition since its FDA approval in October 2011.

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