NATCO files generic Olaparib Tablets in USA

NATCO Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announces 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.

Shares of Natco Pharma Limited was last trading in BSE at Rs. 534.00 as compared to the previous close of Rs. 525.95. The total number of shares traded during the day was 34037 in over 2190 trades.

The stock hit an intraday high of Rs. 549.00 and intraday low of 522.85. The net turnover during the day was Rs. 18299391.00.

Lynparza® is a registered trademark of the AstraZeneca group of companies

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 ANDA ParaIV USFDA OlaparibTablets