Super Generics-First Step of Indian Pharmaceutical Industry in the Innovative Space in US Market

The $90 billion Indian pharma industry has been unable to develop a new drug for the US market despite spending millions in research, even though Indian generics constitutes 40 per cent of US generic drug imports. Ranbaxy and Zydus have been able to launch indigenously developed new drugs in domestic market, but none of the Indian pharmaceutical companies have launched a new drug approved by USFDA. Until a few years ago (2005-2012), Para IV filing opportunities in the US had engaged the Indian firms quiet significantly. Today, that option is no longer is attractive due to limited Para IV opportunities being targeted by numerous firms. Of late, super generics have emerged as the industry's hope for the future. They have caught the attention of branded players as some categories enjoy a measure of patent protection (3-5 years) in US under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FFDCA). This article is aimed at studying the concept of incremental research in pharmaceutical industry, development cycle and regulatory pathway for super generics, profitability estimates and possibilities in future for Indian firms.