Natco Pharma announced the submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Olaparib Tablets 100mg and 150mg.
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer.
Olaparib Tablets are marketed in the United States (US) by AstraZeneca under brand Lynparza.
NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by AstraZeneca and Kudos Pharmaceuticals.
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. Lynparza has recorded sales of USD 1,226 million in the US market for the year ending December 2022, as per AstraZeneca results presentation.
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