Natco Pharma has announced its submission of an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification to the U.S. FDA for the generic version of EVRYSDI® (Risdiplam) 0.75 mg/mL Oral Solution. EVRYSDI, developed by Genentech Inc., is a widely used treatment.
NATCO believes it is among the first two companies to file a substantially complete ANDA for this product. This positions the company to potentially gain 180 days of shared marketing exclusivity upon the generic product’s launch, subject to regulatory approvals and legal proceedings.
The company has been named as one of the defendants in a lawsuit filed in the United States District Court for the District of New Jersey by Genentech, Inc., Hoffmann-La Roche Inc., and PTC Therapeutics, Inc.
