Natco Pharma Seeks FDA Nod for Generic Lung Cancer Drug

Natco Pharma has filed an application with the US FDA for a generic version of Novartis' Tabrecta, used to treat metastatic non-small cell lung cancer. This move potentially grants Natco a 180-day marketing exclusivity period. Tabrecta sales reached USD 126 million in the US in 2023.

Natco Pharma on Thursday announced the submission of a product application to the US health regulator for a generic medication targeting metastatic non-small cell lung cancer.

The company has lodged an abbreviated new drug application (ANDA) featuring a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic counterpart of Novartis' Tabrecta (Capmatinib hydrochloride), according to a regulatory filing.

Natco claims to be the pioneer in filing a substantially-complete ANDA with a Paragraph IV Certification for this drug, anticipating 180 days of exclusive marketing rights upon potential product launch under specified conditions.

Industry data indicates Tabrecta garnered USD 126 million in US sales for 2023.

Capmatinib hydrochloride is intended for adult patients with metastatic non-small cell lung cancer featuring a distinct mutation.

Shares of Natco Pharma declined by 2.66 per cent to close at Rs 1,499.55 each on the BSE on Thursday.

(With inputs from agencies.)