Natco Pharma files ANDA for Bendamustine Hydrochloride powder

Natco Pharma and its marketing partner in the USA, Breckenridge Pharmaceutical, Inc., has filed an Abbreviated New Drug Application (ANDA) for Bendamustine Hydrochloride powder; IV infusion (25mg/vial and 100mg/vial). Breckenridge’s ANDA includes a paragraph IV 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. The company and Breckenridge believe that the ANDA was filed on the first-to-file date, providing 180 days of exclusivity. Teva (Cephalon) sells Bendamustine Hydrochloride under Brand name TREANDA, used as a chemotherapy medicine in oncology segment. According to IMS Health, the market size of Bendamustine Hydrochloride in the USA is approximately $660M for twelve months ending September 2013. 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.