Daijiworld Media Network – Hyderabad
Hyderabad, Jul 6: Granules India on Monday said it has secured sole first-to-file (FTF) status for its abbreviated new drug application (ANDA) for a generic version of Lumryz, a treatment for narcolepsy, strengthening its presence in the US complex generics market.
In a regulatory filing to the BSE, the Hyderabad-based pharmaceutical company said it has submitted an ANDA for sodium oxybate extended-release oral suspension, the generic equivalent of Lumryz extended-release oral suspension.
The drug is used in the United States to treat cataplexy, or sudden loss of muscle control, and excessive daytime sleepiness in patients suffering from narcolepsy.
Under the US regulatory framework, a company granted sole first-to-file status may become eligible for 180 days of generic market exclusivity if it successfully challenges patents protecting the branded medicine and satisfies applicable statutory and regulatory requirements.
The company said this is its second sole first-to-file ANDA. It had earlier secured the status for amphetamine extended-release tablets, the generic version of Dyanavel XR.
Commenting on the development, Granules India Chairman and Managing Director Krishna Prasad Chigurupati said the achievement marked another important milestone in the company's journey in the complex generics segment.
He said the development reflected the company's growing research and development and regulatory capabilities as it continued to build a differentiated pharmaceutical product portfolio.
Established in 1991, Granules India operates across the pharmaceutical value chain, manufacturing active pharmaceutical ingredients, formulation intermediates, finished dosage forms and peptide-based contract development and manufacturing products.
The company has 10 manufacturing facilities across India, the United States and Switzerland, and markets its products in more than 80 countries.