Granules India Secures Sole US FDA First-to-File Status for Generic Narcolepsy Drug

On Monday, the Hyderabad-based pharmaceutical company Granules India Ltd announced that it has secured the sole First-to-File status from the US Food and Drug Administration (FDA) for a key generic drug application. The company, which is headquartered in Hyderabad, received this designation for its abbreviated new drug application (ANDA) for sodium oxybate extended-release for oral suspension. This formulation is a proposed generic version of Alkermes plc’s drug, LUMRYZ extended-release oral suspension.

The achievement marks a major development for the Hyderabad drugmaker in its expansion into the United States healthcare market. Under US regulatory rules, a company that secures sole first-to-file status may receive 180 days of generic market exclusivity in the US, provided that all regulatory and legal conditions are fully met. This exclusivity period would prevent other generic competitors from entering the market during that timeframe.

The brand-name drug, LUMRYZ, is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients suffering from narcolepsy. By launching a generic alternative, Granules India hopes to expand patient access to more affordable treatments for the sleep disorder.

Krishna Prasad Chigurupati, the Chairperson and Managing Director of Granules India, commented on the regulatory milestone. Chigurupati stated that the achievement reflects the pharmaceutical company's research and regulatory strengths. He added that the development supports Granules India's ongoing efforts to build a differentiated portfolio of pharmaceutical products.

This represents the second sole first-to-file ANDA that Granules India has successfully secured. The company's first such designation was for amphetamine extended-release tablets, which are a generic equivalent of Dyanavel XR.

According to the company, this latest filing highlights its steady progress in developing complex generics specifically for the US market. Granules India stated that the milestone successfully strengthens its regulated-market strategy as it continues to grow its presence abroad.