Granules India Limited announced that it 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® extended-release oral suspension.
This achievement marks Granules’ second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release 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 U.S market.
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited, 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 First-to-File 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) 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.
