NATCO files generic Erdafitinib 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 Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths.

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib Tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa®. NATCO has been named as defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech Inc. and Otsuka holdings Co.'s Astex Therapeutics Ltd.

NATCO believes 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.

Balversa® has recorded sales of USD 36.5 million in the US market for the year ending December 2022, as per IQVIA database.

Shares of Natco Pharma Limited was last trading in BSE at Rs. 793.50 as compared to the previous close of Rs. 779.90. The total number of shares traded during the day was 51999 in over 3122 trades.

The stock hit an intraday high of Rs. 797.90 and intraday low of 773.70. The net turnover during the day was Rs. 40982657.00.

Balversa® is a registered trademark of the Janssen group of companies

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 ANDA USFDA Para4Certification ErdafitinibTablets