- 22 Nov 2024
- ICICI Securities
NATCO HAS SUBMITTED THE ANDA WITH USFDA FOR RISDIPLAM ORAL SOLUTION
News: Natco submitted an ANDA containing a Paragraph IV certification to the USFDA for the generic version of Evrysdi (Risdiplam) oral solution. Evrysdi, a brand of Genentech Inc., is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. The medication recorded sales of USD 571 million (₹4,823 crore) in the US market in 2023. NATCO asserts that it is likely among the first two companies to submit a substantially complete ANDA with a Paragraph IV certification for this product and anticipates qualifying for 180 days of shared marketing exclusivity upon the potential launch of the generic product, subject to specific conditions.Notably, NATCO 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.
Views: This filing is in sync with Natco’s strategy of chasing complex and limited competition products in the US. The filing has been challenged by the innovator in a US district court, which could pave the way for a possible out of court settlement. We continue to monitor development on the same.
Impact: Positive