Granules India Secures Sole First-to-File ANDA for Sodium Oxybate ER
Granules India Limited announced on July 6, 2026, it secured Sole First-to-File (FTF) ANDA status for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ®. This is Granules' second FTF ANDA, reinforcing its R&D and regulatory capabilities in complex generics.
Securing Sole First-to-File status for an ANDA indicates a strong competitive advantage in launching a generic drug, potentially leading to increased market share and revenue. However, the actual financial impact will depend on market penetration and competition.
The company has achieved a significant regulatory milestone (Sole First-to-File ANDA status) for a new generic drug, which is a positive development for its business.
Granules India Limited announced on July 6, 2026, 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. This is the generic equivalent of LUMRYZ® extended-release oral suspension.
This achievement represents Granules' second Sole First-to-File ANDA, following their earlier success with Amphetamine Extended-Release Tablets. The company views this as a significant milestone in its complex generics journey, highlighting the strength of its R&D and regulatory capabilities.
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, stated, "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. LUMRYZ® (sodium oxybate) extended-release oral suspension is used 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.
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Granules India Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Granules India Limited. Read the original for the full detail.