Granules India has secured sole first-to-file (FTF) status for its abbreviated new drug application (ANDA) for Sodium Oxybate extended-release for oral suspension, the generic equivalent of Lumryz ER oral suspension of Alkermes plc.

This is Granules’ second sole FTF ANDA and follows the Amphetamine ER tablets, the generic equivalent of Dyanavel XR. LUMRYZ (sodium oxybate) ER oral suspension is indicated in the U.S. for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.

Granules said the sole FTF designation strengthens the company’s position in the complex generics segment and demonstrates its growing capabilities in developing and advancing complex, differentiated generic products for the U.S market.

“It reflects the strength of our research and development and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio,” CMD Krishna Prasad Chigurupati said. Strategic portfolio expansion in regulated markets remains a focus, the company said in a release on Monday (June 6, 2026).