The aforementioned ANDA is the generic equivalent of LUMRYZ extended-release oral suspension.

LUMRYZ (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy. LUMRYZ is a registered trademark of Alkermes plc or its affiliates.

This event marks Granules’ second sole first-to-file ANDA, following its earlier success with amphetamine extended-release tablets, the generic equivalent of Dyanavel XR.

Dr. Krishna Prasad Chigurupati, chairman & managing director, Granules India, said: 'Securing Sole first-to-file status for our sodium oxybate extended release for oral suspension ANDA is another important milestone in our complex generics journey.'

Granules India is a vertically integrated, fast-growing Indian pharmaceutical company. It is among the few pharmaceutical companies in the world to be present across the entire manufacturing value chain — from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs) to peptides CDMO.