Granules has secured sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release (ER) for Oral Suspension, the generic equivalent of LUMRYZ extended-release oral suspension.

This achievement marks Granules’ second sole First-to-File ANDA, following its earlier success with Amphetamine ER tablets, the generic equivalent of Dyanavel XR, and further demonstrates the company’s growing capabilities in developing and advancing complex, differentiated generic products for the US market.

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director (CMD), 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. This achievement reflects the strength of our R&D and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio. We remain focused on expanding patient access to affordable treatment options and delivering sustainable long-term growth.”

The sole FTF designation further strengthens Granules’ position in the complex generics segment and underscores the company’s continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets.

LUMRYZ (sodium oxybate) ER oral suspension is indicated in the US for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.