Natco Pharma Limited has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for a generic version of Tabrecta (Capmatinib hydrochloride). The application includes a paragraph IV certification.
Tabrecta, a brand owned by Novartis, is used to treat adult patients with metastatic non-small cell lung cancer (NSCLC) who have a specific type of mutation. The drug recorded sales of $126 million in the U.S. market in 2023.
Natco Pharma believes it is the first company to file a substantially complete ANDA with a paragraph IV certification for this product. If approved, the company may be eligible for 180 days of sole marketing exclusivity for the generic version under certain circumstances.
The generic version will be available in two strengths: 150mg and 200mg base tablets, equivalent to the brand-name product.
This filing is part of Natco Pharma’s ongoing efforts to expand its generic drug portfolio in the U.S. market. The company has disclosed this information in compliance with SEBI regulations.
