Natco Pharma has submitted an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of TABRECTA (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets.

TABRECTA is the brand of Novartis. Natco claims to be the first company to have filed a substantially complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of the potential launch of the product under certain circumstances.

TABRECTA has recorded sales of USD 126 million in the US market for the year 2023.

Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.