The largest generic and the most sought after target market for Indian Companies involved in the generic business is the US. As more companies gained the expertise to file Foreign Drug Administration (FDA) approval, the number of Abbreviated New Drug Applications (ANDA’s) approved dramatically. In 2005, the number increased to 52 and subsequently increased year on year, to reach 132 in 2008. In 2009, the total number of ANDAs approved was 125. In the first quarter of 2010, further 20 were approved. Recent addition to this is Dr. Reddy’s Laboratories who has received the approval from US Health Regulator to launch generic Zafirlukast tablets, used for treating asthma, in the American market.
The approval by the US Food & Drug Administration (USFDA) for its abbreviated new drug application for Zafirlukast tablets follows a favourable court judgement in the patent infringement case filed against it by patent holder Astra Zeneca, clearing the way for the launch of the product, which the company declared on the day of filing to Bombay Stock Exchange (BSE).
Subsequently on November 18, USFDA approved Dr Reddy’s ANDA for Zafirlukast tablets, a generic version of Astra Zeneca’s Accolate tablets, in the strengths of 10mg and 20mg.
Established in 1984, Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven basic research capabilities. The company develops, manufactures and markets a wide range of pharmaceutical products in India and overseas. Dr. Reddy's produces finished dosage forms, active pharmaceutical ingredients, diagnostic kits, critical care and biotechnology products. The basic research program of Dr. Reddy's focuses on cancer, diabetes, bacterial infections and pain management.
Dr Reddy’s Laboratories have the track record of launching various generic drugs naming Montelukast and Zafirlukast in India. These are non-steroidal drug indicated for prophylaxis and treatment of asthma in India.
Dr Reddy's Laboratories had reported 32 per cent rise in consolidated net profit for the second quarter ended September 30, 2010, to Rs 286.7 crore, banking on a strong performance in the global generic segment. Thus, with strong prospects in the US, coupled with robust domestic formulations growth, Dr Reddy’s Laboratories plans at least one launch every year in the low competition/patent challenge segment.