Natco Pharma’s abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets has received the final approval of U.S. Food and Drug Administration (U.S. FDA).
The product is a generic for Lonsurf, which is indicated primarily for treatment of colorectal cancer. Lonsurf is sold in the U.S. 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 the launch. Lonsurf had generated an annual sales of $211 million in the U.S. during the 12 months ended December 2022, the Hyderabad-based drugmaker on Friday said, citing IQVIA data. Natco shares closed 1.57% lower at ₹629.55 on the BSE.
