Hyderabad: Granules India Ltd on Monday said it has secured the sole first-to-file status from the US Food and Drug Administration (FDA) for its abbreviated new drug application for sodium oxybate extended-release for oral suspension, a proposed generic version of Alkermes plc’s LUMRYZ extended-release oral suspension.The Hyderabad-based drugmaker said the designation is its second sole first-to-file ANDA, after amphetamine extended-release tablets, which were a generic equivalent of Dyanavel XR, and highlights progress in complex generics for the US market. Under US rules, a sole first filer may receive 180 days of generic market exclusivity if regulatory and legal conditions are met.Granules chairperson and managing director Krishna Prasad Chigurupati said the milestone reflects Granules’ research and regulatory strengths and supports its effort to build a differentiated portfolio while expanding access to affordable treatments.LUMRYZ is indicated in the US for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy. Granules said the filing strengthens its regulated-market strategy.
