Zydus Lifesciences Limited — Updates, 16-03-2025: Press Release

Zydus Lifesciences Limited has received final approval from the USFDA for the manufacture of Eluxadoline Tablets, 75 mg and 100 mg, indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). The tablets will be produced at the company’s facility in Ahmedabad. Zydus was among the first to submit a complete ANDA with a paragraph IV certification for this product, making it eligible for 180 days of shared generic exclusivity. The Eluxadoline tablets had annual sales of approximately USD 243.7 million in the U.S. market as of January 2025, presenting a significant commercial opportunity. With this approval, Zydus expands its portfolio, now totaling 419 approvals out of 483 ANDAs filed since FY 2003-04, strengthening its position in the pharmaceuticals market.