Natco Pharma has submitted to the U.S. Food and Drug Administration an abbreviated new drug application for a generic version of Novartis’ cancer drug Tabrecta (capmatinib hydrochloride).
The company believes it is the first to have filed a substantially-complete ANDA containing a paragraph IV certification and expects to be eligible for 180 days of sole marketing exclusivity at the time of potential launch, of the product under certain circumstances, the Hyderabad-based generic drugmaker said on Thursday.
Tabrecta, indicated for treatment of adult patients with metastatic non-small cell lung cancer with a specific type of mutation, had $126 million sales in the U.S. market for 2023. Natco is seeking approval for generic version of Tabrecta Eq 150 mg base and Eq 200 mg base tablets. The company’s shares declined 2.66% to close at ₹1,499.55 each on the BSE.