Natco Pharma submits application with USFDA for generic cancer drug

Natco Pharma announced that it has filed a new application with the US Food and Drug Administration for the marketing authorization of the generic version of Olaparib tablets, which is used to treat certain types of ovarian, breast, pancreatic, and prostate cancer. The firm has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for the product, a generic version of AstraZeneca's Olaparib tablets in strengths of 100mg and 150mg.

AstraZeneca sells olaparib tablets under the brand name Lynparza in the United States. Natco Pharma has been named as a defendant in a lawsuit filed in the United States District Court for the District of New Jersey by AstraZeneca and Kudos Pharmaceuticals. "Based on its filing date, Natco and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA is possibly sole first-to-file and may be eligible for 180 days of marketing exclusivity at the time of product launch," it added.

According to AstraZeneca, Lynparza had sales of USD 1,226 million in the US market for the fiscal year ending December 2022. On the BSE, Natco shares were trading 2.2 percent higher at Rs 537.50 per share.