Sandoz Pulls US Sunosi ANDA, With Competition Still In The Distance

Unichem Recent Deal Pushes Current Expectation To 2042; Other ANDAs Filed

Sandoz’s withdrawal of its ANDA referencing Axsome Therapeutics’ Sunosi sleep disorder drug leaves potential competition years in the future, although other ANDA filers continue to circle.

Withdrawn Stamp
• Source: Shutterstock

Generic competition to Axsome Therapeutics’ Sunosi (solriamfetol) in the US has been tipped to remain from the market until 2040 at the earliest, after Sandoz withdrew its abbreviated new drug application referencing the sleep disorder drug.

Patent-infringement litigation that was pending in the US District Court for the District of New Jersey has been dismissed following...

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