US Generics

The US Generic business is Lupin's main powerhouse of value creation. Lupin continues to increase its market shares for most of its marketed products through increased focus on execution, strong relationships with trade partners and an efficient and responsive supply chain, all supported by a globally integrated team, determined to explore better ways to create value.

In FY 2011, the US Generics business recorded growth of 39% reporting revenues of USD 308 million up from USD 221 million in FY 2010.

Of the 30 generic products marketed in the US, 14 are market leaders in terms of market share. Lupin holds Top 3 positions in 27 out of these 30 generic products and our growth is driven equally by in line as well as new product introductions.

A very lucrative product pipeline, good new product launches, deeper customer relationships and world class Intellectual property capabilities have been the key to the success of our US Generics business. As the fastest growing generic player in the US we believe that we have the required momentum in place to accelerate this growth further. The ceiling is far from reached as we are yet to realize the true value of one of the best generic pipelines in the US market.

During the year, the Company filed 21 Abbreviated New Drug Applications (ANDAs) with the United States Food and Drug Administration (US FDA). The Company continues to maintain its position as one of the Top 10 ANDA filers for the US market. The cumulative number of ANDA filings now stands at 148, with 48 approvals received till date. Lupin has 77 Para IV Filings with the US FDA. The cumulative first-to-file opportunities for the US generics market now stands at 20.