Natco Pharma has submitted abbreviated new drug application (ANDA) for Risdiplam for oral solution, a generic version of Genentech Inc’s spinal muscular atrophy drug Evrysdi (Risdiplam) 0.75 mg/mL for oral solution.
Natco said it believes it is among one of the first two companies to have filed a substantially-complete ANDA containing a paragraph IV certification for the product. It thus expects to be eligible for 180 days of shared marketing exclusivity at the time of potential launch of the generic product under certain circumstances, Natco said on Thursday.
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, Hoffmann-La Roche Inc. and PTC Therapeutics, Inc., it said. Evrysdi has recorded sales of $571 million in the U.S. market for the year 2023.
Published – November 22, 2024 01:06 am IST
