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Two Form Vanguard For First US Rivals to Banzel Suspension

 
• By Aidan Fry

Two companies now hold final US approvals for generics of Eisai’s Banzel oral suspension. But patent-litigation settlements could delay the entry of Bionpharma and Hikma to market.

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Two companies are the first to obtain final US approval for generic rufinamide suspensions • Source: Shutterstock

Bionpharma and Hikma have become the first two companies to obtain final abbreviated new drug application (ANDA) approvals for alternatives to Eisai’s Banzel (rufinamide) 40mg/ml oral suspension. Approvals for the treatments for seizures associated in pediatric and adult patients with Lennox-Gastaut Syndrome came just after the end of a six-month pediatric extension to Eisai’s US patent 7,750,028 on 19 April. But it is currently unclear when the generics will enter the market.

Hikma’s Roxane Laboratories had in late-2014 been sued by Eisai for alleged infringement of both the ‘028 patent and US...

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