Natco Pharma Limited — Updates, 21-11-2024: Press Release

Natco Pharma has submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA for a generic version of Risdiplam, indicated for spinal muscular atrophy treatment. This application includes a paragraph IV certification, positioning Natco as one of the first two companies to file this type of ANDA. The company anticipates potential marketing exclusivity for 180 days upon launch. In 2023, EVRYSDI, the branded version of Risdiplam by Genentech, recorded sales of USD 571 million in the U.S. market. Notably, Natco is involved in a lawsuit filed against it regarding this product. This development suggests a potential growth opportunity in the competitive generic pharmaceuticals market for Natco. Investors should watch closely as the situation evolves.