NATCO bags USFDA final nod for Tipiracil Hydrochloride and Trifluridine for US market

Natco Pharma Limited has announced the 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., the company informed.

As per the regulatory filing, Natco is one of the First-to-File for the product and may be eligible for a 180-day exclusivity at the time of launch. 

Further, 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, the company said.

Source: Media reports