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Sun Pharma In The News

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Indian pharma remains top in us generics

But the newer entrants prove nimbler than the slowing pioneers

 
Indian pharmaceutical companies led by Glen-mark, Aurobindo and Sun Pharma maintained their number one posi'tion in the US generics market, by bagging 33.17 per cent or 139 of 419 original Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (FDA) in 2010.
 
The Indian companies had a similar 33.17 per ent share or 142 of 428 ANDA approvals in 2009.
 
Generics are reverse-engi'neered, cheap versions of branded patented drugs.
 
Late-comers rise
Data from the FDA website for the past two years shows Glen-mark, Sun Pharma, Lupin and Aurobindo are going to dominate the US market in the coming years, likely displacing top drug companies such as Ranbaxy Laboratories and Dr Red-dy's Laboratories. These two leading Indian companies were the first among domestic drug manufacturers to enter and dominate the US generic mar'ket for the past decade.
 
Glenmark and its US sub'sidiary, Glenmark Generics, received the highest approvals from FDA in the past year, 18, bettering its previous year's performance of 11 approvals. Aurobindo Pharma, which led in 2009 with 18 approvals, came close behind with 17 ap'provals last year.
 
"We will continue with an average 15-20 filings every year in the US and will expand our of'ferings across therapies, especially niche segments. Our prod'ucts have been selling in the US for about six years and in such a short time, we have emerged as a leading generics organi'sation in the US, by growing organically," Glen Saldanha, man'aging director and chief executive of Glenmark Pharmaceuti'cals told Business Standard.
 
Glenmark's aggressive filings stem from the fact that the company is not looking at contract manufacturing alliances and is trying to build a prod'uct portfolio of itself in the US, said analysts.
"The US will remain the sin'gle largest pharmaceutical mar'ket, with three to five per cent growth expected next year. Pharmaceutical sales in the US will reach $320-330 billion," said a recent IMS Health report. The US generics market, which accounts for a little over 70 per cent of prescriptions in the US, was valued by IMS at about $31 bil'lion for the 12 months ended No'vember 2009. BCC Research estimates the US market had generic sales worth $34 bn in 2009.
Sun Pharma and its acquired Israeli subsidiary, Taro Pharmaceuticals, together got 15 approvals in 2010, as against 19 in the previous year. This is despite the fact that Sun's US subsidiary, Caraco Pharmaceuticals, which is facing a ban on production in the US due to regulatory issues, did not receive any final ap'provals for the past two years.
 
in 2009, but that number slumped to 11 in 2010. Ranbaxy facing FDA regulatory issues for its two facilities in India for the past few years, had only seven approvals in 2009 and just three in 2010. Both Dr Reddy's and Ranbaxy used to top the chart in previous years, with several approvals every year. Similarly, Wockhardt, which had 14 approvals in 2009, got only four in 2010.
 
"It is clear that Ranbaxy and Dr Reddy's are slowing in the US and others are catching up. If Dr Reddy's is now focusing more on large contracts with multi'national drug companies, like the one it did with Glaxo-SmithKline, Ranbaxy's trouble will continue till it resolves the FDA issues," said Ranjit Kapadia, vice-president, institution'al research, HDFC Securities.
 
Lupin is also emerging as a major Indian company in the US. It got just three approvals in 2009 but 12 in the past year. Lupin is already among the top five generic drug companies operating in the US market in terms of number of pre'scriptions, a first among In'dian generic companies selling drugs in the US.
 
Other leading Indian com'panies in the US market include Zydus Cadila, Alembic, Orchid, Strides Arcolab, Torrent, Hetero Drugs, Alkem Labs, Emcure and Unichem, with one to six approvals each in the past two years.