)
Breckenridge Pharmaceutical Inc, a marketing partner in the US for Hyderabad-based pharmaceutical and bulk chemicals manufacturer Natco Pharma Limited, has filed an abbreviated new drug application (ANDA) for bendamustine hydrochloride powder, intravenous infusion (25mg/vial and 100 mg/vial).
Bendamustine hydrochloride powder is sold under the Treanda brand name by Teva Pharmaceutical Industries Limited’s subsidiary Cephalon Inc. It is used as chemotherapy medicine.
In a filing to the BSE on Monday, Natco said Breckenridge’s ANDA included a certification to obtain approval to engage in the commercial manufacture, use or sale of the drug before expiration of the ‘190’, ‘524’ and ‘863’ patents.
“Natco and Breckenridge believe that the ANDA was filed on the first-to-file date, providing 180 days of exclusivity,” the company said.
Natco Pharma's scrip is currently trading at Rs 840 on the BSE, up 2.83%, over the previous close of Rs 816.85 a share.
