Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced its submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension.
Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer®. NATCO believes that its ANDA is possibly the sole firstto-file based on the filing date. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product.
Tracleer® is indicated for the treatment of pulmonary arterial hypertension. As per Johnson & Johnson's annual report, for the year ending 2018, Tracleer® had registered sales of approx. $268million in the US market, and the 32 mg is one strength that is indicated for pediatric patients.
Shares of NATCO PHARMA LTD. was last trading in BSE at Rs.546.95 as compared to the previous close of Rs. 532.95. The total number of shares traded during the day was 14222 in over 572 trades.
The stock hit an intraday high of Rs. 558.9 and intraday low of 524. The net turnover during the day was Rs. 7634803.