Lupin, DRL in US big league
In a first, two Indian drug firms, Lupin Ltd and Dr Reddy’s Ltd, have made it to the list of top 10 generic companies in the fiercely competitive US market, placed eighth and tenth, respectively, in 2009. These companies have improved their standing in the $34-billion US generic market despite their apparent failure in getting market exclusivity under the highly-lucrative-yet-risky route of Para IV filings.
Lupin and DRL have also emerged as the fastest growing among the top 10 generic players in the US market, with Lupin growing at 50% and DRL at 40% just when three big players in the top-10 club have shown negative growth. The US generic drugs market is estimated to grow at a CAGR of 8.8% during 2010-2013.
Indian drug companies have been expanding in the US market through the ordinary ANDA (abbreviated new drug application) route, and in some cases, through out-of-court settlement with patent-holders who are keen to fend off a Para IV challenge. Such settlements tag the generic company as a player authorised by the patent-holder, normally an advantage in drubbing competition. A Para IV filing makes it must for the ANDA applicant to prove that its product or the use of it does not infringe on the patents listed in the relevant document (Orange Book), or that the relevant patents are invalid.
Lupin and DRL’s growth figures also outshine the average growth recorded by the top 10 generic firms at 6.5% in 2009 and the average growth of global pharma industry at just over 5.5%. While Lupin has climbed two notches up in the pecking order to the eighth position by improving its market share from 2.5% in 2008 to over 3.5% in 2009, DRL has broken into the hallowed league year by bettering its market share to 2.7% from 2.1%, according to the National Prescription Audit conducted by IMS in the US.
DRL had last year announced its aim to join the top-five list in next three-four years. Lupin, industry analysts believe, could achieve this feat faster. Considering that the gap between market shares of Pfizer’s subsidiary Greenstone which stands at fifth rank and Lupin is only of 0.8% point, it sounds fairly achievable.
The launch of the cardiovascular drug amlodipine (the generic version of Novartis’s Lotrel), combined with the four other US FDA approvals the company received this year, could boost its chances of entering the top-five club shortly. The year 2009 also saw Lupin emerging as the market leader in 10 out of the 23 products it has introduced in the US market. In 18 products, Lupin ranked in the top three by market share.
April 27, 2010