Natco Pharma Ltd.

NATCO Pharma has submitted Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (USFDA) 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.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.