Indian pharma cos adapting to us norms

The Indian pharma firms are devising new strategies to continue the business growth.


Hyderabad, May 27, 2014: The Indian generic drug companies are looking at new strategies to continue to benefit from the world’s largest pharmaceutical market, the US, as the exclusive marketing rights for off patent drugs are losing sheen. It has been reported that the US Food and Drug Administration (USFDA) has been clearing applications to make generic drugs that are going off patent at a fast pace that is resulting in increased competition in the US market.


Additionally, the FDA has been granting the joint ‘first to file’ (FTF) status for several generics diluting the value of the exclusive marketing right that comes with such a status. It may be noted here that FTF refers to a drug that enjoy a 180-day exclusive marketing period in which no other generic versions can be sold.


It is noteworthy that FTFs are a critical factor for growth for Indian companies that are making generic versions of expensive drugs. However, with the FDA amending guidelines to allow joint firsts to copycat drugmakers, the era of windfall gains from FTF is over.


In this changing scenario, the Indian drug firms are looking at niche products with huge entry barriers like complex generics. In fact, this strategy has resulted in increasing spends on R&D from the Indian drug firms significantly.


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