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News: Natco Submitted ANDA containing a paragraph IV certification with the USFDA for the generic version of TABRECTA(brand of Novartis) (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets. Company believes it is 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 potential launch of the product under certain circumstances. TABRECTA has recorded sales of USD 126 million(Rs 1057 crore) in the US market for the year 2023 and is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.
Views: This is the new addition in Natco's list of limited competition products that the company is pesuing in the US. Although the launch timing and possible patent challenge from the innovator are some important aspects, Natco in the past has demonstrated capability to overcome such aspects.
Impact: Positive