Natco Pharma informed that it has submitted the abbreviated new drug application (ANDA) with the United States Food and Drug Administration (USFDA) for Risdiplam for oral solution.
The ANDA is a generic version of Evrysdi (Risdiplam) for oral solution by Genentech Inc.Risdiplam for oral solution is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
The drug maker believes it is amongst the first two companies to have filed a substantially complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of shared marketing exclusivity at the time of potential launch of the generic product under certain circumstances.
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.
Evrysdi has recorded sales of $571 million in the US market for the year 2023.
Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations. The company has manufacturing facilities in India which caters to both domestic and international markets including regulated markets like the United States of America and Europe.
The companys consolidated net profit surged 83.55% to Rs 677.30 crore on a 32.93% increase in revenue from operations to Rs 1,371.1 crore in Q2 FY25 over Q2 FY24.
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