Natco Pharma files ANDA for Trifluridine/ Tipiracil tablets

Natco Pharma announced its submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Lonsurf (Trifluridine/ Tipiracil) tablets (15mg/6.14mg and 20mg/8.19mg). NATCO believes that it is one of the first ANDA filers for the product and could be eligible for 180 days exclusivity under certain circumstances.

Lonsurf has recorded sales of USD 150 million for the year ending December 20 18 in the US market as per IQVIA. The drug is currently indicated for certain forms of Colorectal and Gastric Cancers. Lonsurf is a registered trademark of Taiho Oncology, INC.

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