Natco Pharma on Monday said it has submitted Abbreviated New Drug Application (ANDA) certification with the US Food and Drug Administration (FDA) for the generic version of Olaparib Tablets -- of 100mg and 150mg.
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer. It is marketed in the US by AstraZeneca under brand Lynparza.
"NATCO and its co-development and marketing partner Alembic Pharmaceuticals believe that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch of the product," the pharma company said in a regulatory filing to the exchanges.
In 2022, Lynparza has recorded sales of USD 1,226 million in the US market, the filing said, citing AstraZeneca results presentation.
( With inputs from ANI )
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