Aurobindo expects drug filing opportunities in US to stay for another 5 yrs

Indian generics company Aurobindo Pharma Limited on Wednesday said the opportunity of launching new generic drugs in the US market would be inexhaustible at least for the next five years.

With sales growth in the increasingly competitive US market largely dependent on the number of new product launches, a robust pipeline of new drug filings becomes a basic prerequisite for a generics drug player to keep its business growing year after year.

Responding to an analyst's question on how many more years would the company be able to file the abbreviated new drug applications (ANDAs) for approval of new launches at the current rate of filing, Aurobindo Pharma founder chairman P V Ramprasad Reddy said there was a scope to file 60-70 ANDAs per year for another five years from now.

Emerged as one of the aggressive Indian generics players in seeking to file product approvals for the drugs going off-patent in the US market, Aurobindo has been filing around 40 ANDAs each year in recent past. It has a cumulative total of 510 ANDA filings out of which the US Food and Drug Administration (US FDA) had already accorded final approval for 356 products.

The company had launched 14 new products, including two injectables in the US market during the second quarter ended September 2018. Its US sales for the period stood at Rs 22.27 billion, which accounted for 47 per cent of the total company revenues for the period, registering a 6.1 per cent increase at current prices, declined by 2.6 per cent on constant currency basis, even after a reasonably high number of launches during the period.

The company has been acquiring ANDAs from other companies in addition to the in-house filings and its management told in the analyst call that it would keep looking for acquisition of such products especially to ramp up its branded generics portfolio.

In a related development, the company, which has announced the acquisition of a generic inhaler product under development from an Australian company yesterday said it was looking to file the ANDA in 2020 and expect product approval for the same by 2021.

The senior management of Aurobindo said they are looking at launching the Oncology products in the US market by the end of this year. 

Coming to the Chinese impact on the cost of raw materials, Aurobindo managing director N Govindarajan said in-house manufacturing and new partnerships aimed at producing certain drug intermediates locally has been pursued while keeping a watch on the Chinese developments. There has been a single-digit impact on raw material costs due to rise in prices of raw material imports from China, according to the company officials.