Granules India Secures Sole First-to-File ANDA for Generic LUMRYZ®, Bolstering Complex Generics Play

Granules India Limited is making significant waves in the global pharmaceutical arena. Recently, they announced a pivotal achievement that promises to bolster their competitive edge within the complex generics segment.

On July 6, 2026, the Hyderabad-headquartered company secured Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-release Oral Suspension – the generic equivalent of LUMRYZ® extended-release oral suspension. This “Sole First-to-File” designation is a highly coveted achievement in the pharmaceutical industry, typically granting the first generic applicant 180 days of market exclusivity upon approval, following the brand reference patent’s expiration. Such FTF status creates a crucial competitive advantage and can be a significant pathway to capturing substantial market share.

This strategic win for Granules India Limited marks its second Sole First-to-File (FTF) ANDA approval, building on an earlier success with Amphetamine Extended-release Tablets (generic equivalent of Dyanavel XR®).

The repeated successes underscore the company’s robust research and development capabilities and its strong commitment to developing complex, differentiated generic products for the lucrative U.S. market.

Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, emphasized this point: “This achievement reflects the strength of our R&D and regulatory capabilities while reinforcing our dedication to building a differentiated portfolio.”

For investors, securing Sole FTF status signals Granules India Limited’s continued ability to navigate intricate regulatory pathways successfully. LUMRYZ® (sodium oxybate) treats cataplexy or excessive daytime sleepiness in patients with narcolepsy – conditions involving significant unmet needs. The ANDA approval provides a potential avenue for substantial sales, estimated from IQVIA data at around $120 million annually.

By expanding access to affordable treatment options, Granules India Limited continues its mission while driving sustainable long-term growth and solidifying its position as an innovator in the complex generics landscape.