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Sun Pharma announces USFDA approval for generic Uroxatral ER Tablets
Sun Pharma announced that USFDA has granted its subsidiary an approval for its
Abbreviated New Drug Application (ANDA) to market a generic version of Uroxatral ER,
alfuzosin hydrochloride extended release tablets. Sun Pharma, being the first-to-file an
ANDA for generic Uroxatral ER with a Para IV certification, has received a 180-day
marketing exclusivity. These alfuzosin hydrochloride 10mg tablets are therapeutically
equivalent to Uroxatal Extended Release tablets from sanofi-aventis. Alfuzosin
hydrochloride extended release tablets have annual sales of approximately US$250mn in
the US. Though a niche opportunity, the product is expected to contribute US$31mn and
US$16mn to the company’s sales and net profit, respectively. We are currently not
changing our estimates. At the CMP, the stock trades at 28.3x FY2012E and 21.6x
FY2013E earnings, respectively. We remain Neutral on the stock.
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