Indian pharmaceutical firm Natco Pharma has gained the US Food and Drug Administration (FDA)’s final approval for its abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf.

The original drug, produced by Taiho Oncology Inc., is primarily used for treating colorectal cancer.

Natco Pharma’s potential First-to-File status for the product may entitle the company to a 180-day exclusivity period at the time of launch. Given that Lonsurf generated annual sales of $211 million in the USA in the twelve months ending December 2022, as per IQVIA data, this exclusivity could position Natco Pharma favorably in the market.

This approval marks a significant milestone for the pharmaceutical company, expanding its portfolio in the oncology sector and paving the way for more affordable treatment options for patients battling colorectal cancer in the United States.

  Colorectal cancer, Lonsurf, Natco Pharma, Oncology, Taiho Oncology, Tipiracil Hydrochloride and Trifluridine Tablets, US FDA, US Food and Drug Administration, USA