Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced final approval for its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf®) from the U.S. Food and Drug Administration (USFDA). Lonsurf® is sold in the US by Taiho Oncology Inc.

Natco believes it is one of the First-to-File for the product and may be eligible for a 180-day exclusivity at the time of launch. Lonsurf® is indicated primarily for the treatment of colorectal cancer. As per IQVIA data, Lonsurf® had generated annual sales of $211 million in USA during the twelve months ending December 2022.